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U.S. Department of Health and Human Services

Medical Devices

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Device Problem Code Hierarchy

Subset: Device Issue

  • Device Operational Issue - LEVEL 1 - Issue associated with any deviations from specifications relating to device operations (e.g. deployment, connection, electrical, computer software, infusion/flow, output, protective measure, and incompatibility issues).
    • Device Operates Differently than Expected C62955; FDA 2913 - Issue associated with any deviations from expected performance while operating and using the device.
      • Device displays error message C63205; FDA 2591 - Issue associated with a device prompting user with an error message in order to indicate a device problem
      • Device Stops Intermittently C62924; FDA 1599 - Issue associated with any deviation from device document specification relating to the irregular rate at which the device stops.
      • Failure to adhere or bond C63032; FDA 1031 - Issue associated with difficulties in attaching a device to another object including another device or device component or to a patient body part.
      • Failure to Fire C63177; FDA 2610 - Issue associated with a therapy or algorithm not being delivered or executed at the expected time.
      • Failure to Obtain Samples C63172; FDA 2533
      • Failure to Prime C63167; FDA 1492
      • Misassembled C62958; FDA 1398 - Issue associated with the use of the device characterized by incorrect assembly of device components, parts or constituents.
      • Prompts will not Clear C62861; FDA 2281
      • Therapy delivered to incorrect body area C62858; FDA 1508 - Issue associated with the device causing unintended therapeutic action to an area of the body other than the intended area.
      • Unintended Ejection C62817; FDA 1234 - Issue associated with unexpected discharge of device from expected location includes but not limited to devices such as clip appliers, film cartridge, staples
    • Calibration Issue C63028; FDA 2890 - Issue associated with the operation of the device, related to its accuracy, and associated with the calibration of the device
      • Failure to Calibrate C62994; FDA 2440 - Issue associated with the failure of the device to perform a self-calibration procedure or process designed to assure the accuracy and proper performance of the device.
        • Calibration Error C63284; FDA 1078
        • Failure to Recalibrate C63241; FDA 1517
        • Imprecision C63113; FDA 1307
      • Overcorrection C72890; FDA 3006 - Issue associated with an adjustment that surpasses a set of criterion.
    • Computer Software Issue C63269; FDA 1112 - Issue associated with written programs, codes, and/or software system that affects device performance or communication with another device.
      • Application Network Issue C64349; FDA 2879 - Issue associated with the deviations from documented system specifications that affects overall system performance and/or the performance of an individual device or collection of devices connected to that system.
      • Application Program Issue C63305; FDA 2880 - Issue associated with the requirement for software to fulfill its function within an intended use or application.
        • Application Interface becomes nonfunctional or program exits abnormally C63306; FDA 1138
        • Application Program Version or Upgrade Problem C63304; FDA 2881
        • Incorrect Error Code C63206; FDA 2963
        • Problem with Software Installation C67507; FDA 3013 - Issue associated with installing the device software in a manner that allows full functioning of the device. Source of installation could be manufacturer or user.
        • Programming Issue C62839; FDA 3014 - Issue associated with the written program code or application software used to satisfy a stated need or objective for functioning of the device. These do not include issues associated with the operating system
          • Incorrect Software Programming Calculations C63081; FDA 1495
            • Dose Calculation Error due to Software Problem C63220; FDA 1189
            • Parameter Calculation Error due to Software Problem C63083; FDA 1449
            • Power Calculation Error due to Software Problem C62916; FDA 1473
          • Medication Error C91396; FDA 3198 - Event in which the device software design results in errors of medication preparation or administration.
      • Data Issue C91397; FDA 3196 - Event in which data (charting, orders, results) is not correctly stored, transferred, updated, or displayed.
        • Loss of Data C63257; FDA 2903 - Event in which information is unintentionally permanently or temporarily lost, deleted, corrupted, or overwritten.
        • Patient Data Issue C91398; FDA 3197 - Event in which information is accessed by the healthcare provider and either the wrong patient or the wrong information is retrieved despite correct inquiry procedures.
      • Computer Operating System Issue C63270; FDA 2898 - Issue associated with the machinery operating system, a collection of software, firmware, and hardware elements that control the execution of computer programs and provides such services as computer resource allocation, job control, input/output control, and file management in a computer system.
        • Operating System Becomes Nonfunctional C62894; FDA 2996 - Issue associated with malfunction of the computer operating system as opposed to an application software issue.
        • Operating System Version or Upgrade Problem C62893; FDA 2997 - Issue associated with replacing an older operation system to an up-to-date operation system.
      • Computer System Security Issue C64348; FDA 2899
        • Unauthorized Access to Computer System C63259; FDA 3025 - Issue associated with an access that was not permitted to the computer system that may lead to modification of program, corruption of data, or and break in network security. This concept is closely associated with computer integrity which is the degree to which a system or component prevents unauthorized access to, or modification of, computer programs or data.
          • Application Security Issue C63042; FDA 2882 - Issue associated with the acquisition of computer programming codes that can replicate and spread from one computer system to another thereby leading to damaged software, hardware and data.
      • Data Back-Up Problem C63258; FDA 2902 - Issue associated with problems relating to a system, component, file, procedure, or person available to replace or help restore a primary item in the event of a failure or externally caused disaster.
        • Failure to Back-Up C63195; FDA 1047 - Issue associated with the inability to backup or to retrieve a backed up version (corrupted file) of device data or system files.
        • Failure to Convert to Back-Up C63189; FDA 1048
      • Date-related software issue C67508; FDA 2582 - Issue associated with programming of calendar dates and/or time as a factor in the operation of a medical device.
    • Connection Issue C62952; FDA 2900 - Issue associated with linking of device and/or device components and/or the functional units set up to provide means for a transfer of liquid, gas, electricity or data.
      • Blocked Connection C63288; FDA 2888 - Issue associated with linking of device and/or device components whereby their functional units set up to provide means for a transfer of fluid, gas, or data is prevented or impeded.
      • Decoupling C63256; FDA 1145 - Issue associated with the device and/or device components being unassociated in such a way that fluid, gas, power or signal information may not be transferred from one to another.
      • Disconnection C63223; FDA 1171 - Issue associated with the linking of device and/or device components having a sufficient open space to prevent gas, liquid or electrical current flow between connectors.
      • Failure to Disconnect C63180; FDA 2541 - Issue associated with the linking of device and/or device components whereby termination of the transfer of liquid, gas, electricity, or information cannot be accomplished, or linking components do not come apart, or disconnect, when expected.
      • Fitting Problem C63142; FDA 2183 - Issue associated with the connection of device and/or device components whereby channels, switching systems, and other functional units set up to provide means for a transfer of liquid, gas, electricity, or information do not match or fit.
      • Loose or Intermittent Connection C63055; FDA 1371
      • Misconnection C62915; FDA 1399 - Issue associated with the connection of device and/or device components being improper or not in accordance with device specification, requirements and intended uses.
    • Deployment Issue C63013; FDA 2906 - Issue associated with any deviations from device documented performance specifications relating to the sequence of events for activation and positioning of the device or one of its components into a specific body location.
      • Difficult to Deploy C63244; FDA 1157 - Issue associated with users experiencing difficulty or uneasiness to deploy device and/or device components to a specified location.
        • Difficult or Delayed Activation C63035; FDA 2577
      • Failure to Deploy C63183; FDA 1158 - Issue associated with the inability of device and/or device components to be activated and positioned in a specified location.
      • Failure to Expand C96715; FDA 3270 - Issue associated with the device or one of its components failing to expand.
      • Failure to Separate C63159; FDA 2547 - Issue associated with the device or one of its components failing to detach or separate as intended.
      • Premature Deployment C62863; FDA 1484 - Issue associated with an early and unexpected deployment of the device and/or device components from the system.
      • Self-Activation or Keying C62844; FDA 1557 - Issue associated with the unintended activation of device, or device having been unexpectedly turned on during use.
    • Electrical Issue C63007; FDA 1198 - Issue associated with a failure of the electrical circuitry or components of the device
      • Capturing Issue C63027; FDA 2891 - Issue associated with the inability of device and/or device components to achieve successful depolarization and contraction of a cardiac chamber caused by a pacemaker output pulse.
        • Failure to Capture C62993; FDA 1081 - Issue associated with the failure to achieve effective and consistent depolarization of the heart resulting from the electrical stimulus of the pacemaker.
        • High Capture Threshold C95875; FDA 3266 - Issue with the amount of output energy needed to cause cardiac depolarization being higher than expected/desired.
        • Intermittent Capture C63069; FDA 1080 - Issue associated with the ineffective and inconsistent depolarization of the heart.
        • Unstable Capture Threshold C95876; FDA 3269 - Issue with the amount of output energy needed to cause cardiac depolarization being unstable.
      • Continuous Firing C63265; FDA 1123 - Issue associated with the excessive production of electrical impulses over a period.
      • Power Source Issue C63025; FDA 3010
        • Battery Issue C63030; FDA 2885
          • Battery Impedance Issue C64334; FDA 2884
            • High Battery Impedance C64336; FDA 2947
            • Low Battery Impedance C64335; FDA 2973
          • Failure to Run on Portable Mode C62990; FDA 1466
          • Low Battery C63048; FDA 2584
          • Premature Discharge of Battery C62864; FDA 1057
        • Charging Issue C63026; FDA 2892 - Issue associated with the inability of device and/or device components to successfully charge an electrical source.
          • Aborted Charge C63281; FDA 2288 - Issue associated with the premature ending of the charging process (e.g. of a battery or other charge storage device).
          • Delayed Charge Time C63280; FDA 2586 - Issue associated with an unexpected amount of time required to charge the device as required (for example, a delay in starting charging or a longer than expected charge time).
          • Failure to Charge C63193; FDA 1085 - Issue associated with inability to initiate the appropriate charging process (e.g. of a battery or other charge storage device)
        • Failure to Power-Up C62992; FDA 1476
          • Failure to Run on AC/DC C63162; FDA 1001
        • Unintended Energization C62818; FDA 1162
      • Device Inoperable C62979; FDA 1663 - Issue associated with the device being in a nonfunctional or inoperable state and cannot be used unless the causes of the inoperability are located and fixed.
      • Device Sensing Issue C63238; FDA 2917 - Issue associated with device features that are designed to respond to a physical stimulus (temperature, illumination, motion, cardiac rhythms) that do not transmit a resulting signal for interpretation or measurement.
        • Failure to Sense C63160; FDA 1559 - Issue associated with the failure of a device designed to respond to a physical stimulus (as temperature, illumination, motion) to transmit a resulting signal for interpretation or measurement.
        • Invalid Sensing C63061; FDA 2293 - Issue associated with the inaccuracy of a device designed to respond to an input (such as temperature, illumination, motion) to transmit a resulting signal that can not be used for interpretation or measurement.
          • Decreased Sensitivity C63253; FDA 2534 - Issue with the device being less sensitive to an input than intended or expected.
          • Failure to Analyze Rhythm C63196; FDA 1539
          • Failure to Select Signal C63161; FDA 1582
          • High Sensing Threshold C63121; FDA 2574 - Issue associated with the amount of input required by the device to detect a signal being higher than expected/desired.
          • Incorrect Interpretation of Rhythm C63086; FDA 1543
          • Increased Sensitivity C63078; FDA 2535 - Issue with the device being more sensitive to an input than intended or expected.
          • Loss of Threshold C63050; FDA 1633 - Issue associated with the loss of the minimum amount of energy, voltage, or current needed to consistently stimulate the heart muscle.
          • Low Sensing Threshold C63044; FDA 2575 - Issue associated with the amount of an input required by the device to detect a signal being lower than expected/desired.
          • Over-sensing C62881; FDA 1438
          • Sensing Intermittently C63065; FDA 1558
          • Under-sensing C62822; FDA 1661
      • Failure to Conduct C63191; FDA 1114 - Issue associated with the inability of a device and/or device components to allow a current of electricity to pass or to conduct electricity continuously along an electrical path.
      • Failure to Convert Rhythm C63190; FDA 1540 - Failure of a device therapy or set of therapies to terminate the arrhythmia that the therapy is meant to terminate.
      • Failure to Interrogate C63173; FDA 1332 - Issue associated with the device failure to appropriately respond to signals from a system designed to interrogate its status.
        • Difficult to Interrogate C63232; FDA 1331 - Issue associated with difficulty of a transponder system to trigger a response.
      • Failure to Pace or Properly Pace C63169; FDA 1439 - Issue associated with the inability of device and/or device components to generate a therapeutic simulated heart beat via electrical impulses once arrhythmia is detected.
        • Failure to Convert Rhythm C63190; FDA 1540
        • Failure to Spike C63157; FDA 2536 - Failure of device to generate a correctly-shaped pacing output, for example, a waveform that is too wide.
        • Inaccurate Synchronization C63101; FDA 1609 - Issue associated with an error due to imperfect timing of two operations; this may or may not include signal transmission time.
        • No Pacing C95877; FDA 3268 - Issue associated with the device ceasing to deliver paces.
        • Pacer Found in Back-Up Mode C62880; FDA 1440
        • Pacing Asynchronously C63298; FDA 1441 - Issue associated with a pacing transmission process such that between any two significant instants in the same group, there is always an integral number of unit intervals. Between two significant instants located in different groups, there are not always an integral number of unit intervals.
        • Pacing Inadequately C63097; FDA 1442 - Pacing voltage or pulse width is less than desired.
          • Pocket Stimulation C62872; FDA 1463 - Issue associated with a pocket of skin in which the pulse generator is housed.
        • Pacing Intermittently C63066; FDA 1443 - Issue associated with the failure of pacing device for a limited period of time, following which the item recovers its ability to perform its required function without being subjected to any external corrective action. Note: such as failure is often recurrent.
      • Failure to Shock or Properly Shock C63158; FDA 1573 - Issue associated with the inability of device and/or device components to provide an appropriate or successful electrical shock
        • Failure to Deliver Counter-shock C63185; FDA 1133 - Issue associated with the effective electromotive force within a system that fails to oppose the passage of current in a specified direction.
        • Failure to Discharge C63181; FDA 1169 - Issue associated with the failure of a battery or other charge storage device to appropriately discharge as intended.
        • Inappropriate Shock C63093; FDA 1574 - Issue associated with the inappropriate delivery of an electrical energy
        • Intermittent Shock C63064; FDA 2287 - Issue associated with the failure to deliver shock for a limited period of time, following which the item recovers its ability to perform its required function without being subjected to any external corrective action. Note: such as failure is often recurrent.
      • Grounding Malfunction C63125; FDA 1271 - Issue associated with the inability to connect conductors of an electronic system for the purpose of controlling or impeding ground currents and voltages.
    • Incompatibility Problem C62983; FDA 2960 - Issue associated with the device not being compatible with another device component or substance (medication, body fluid etc) that it contains or transports. Does not refer to device issues related to disconnection.
      • Component or Accessory Incompatibility C63020; FDA 2897 - Issue associated with the incompatibility of any device and/or device components while being operated in the same use environment thereby leading to a dysfunction between the device and its components.
        • Accessory Incompatible C63036; FDA 1004
        • Component Incompatible C63022; FDA 1108
      • Device-Device Incompatibility C63236; FDA 2919 - Issue associated with the incompatibility of two or more devices while being operated in the same use environment thereby leading to a dysfunction of more than one device.
      • Patient-Device Incompatibility C62919; FDA 2682 - Issue associated with the interaction between the patient's physiology or anatomy and the device that affects patient and/or device. (e.g. biocompatibility - Issues, patient's weight exceeds safe working load of a lifting device.)
        • Rejection C62853; FDA 1524
        • Size Incorrect for patient C62947; FDA 1583
      • Measurement System Incompatibility C63040; FDA 2982 - Issue associated with the incompatibility of the measurement systems between and/or within device systems that are inherent to the individual device thereby leading to miscalculated or mismatched measurements from those devices, e.g., international metric system versus U.S. measurement system.
    • Infusion or Flow Issue C63075; FDA 2964 - Issue associated with the device failing to deliver liquids or gases as intended (e.g. delivering drugs at incorrect rate, issues with drawing fluid from a system etc)
      • Deflation Issue C63249; FDA 1149 - Issue associated with the inability of device and/or device components to release its contents
      • Excess Flow or Over-infusion C62882; FDA 1311 - Issue associated with an overdose of delivery therapy, e.g., air, gas, drugs or fluids being delivered into a device or a patient under positive pressure that is being generated by a pump.
      • Filling Problem C63144; FDA 1233 - Issue associated with the method or amount of time associated with the delivery of a fluid. Time to delivery or amount of delivered entity may be affected.
        • Inability to Auto-fill C63106; FDA 1044
        • Overfill C62884; FDA 2404
        • Short Fill C62841; FDA 1575
        • Volume Accuracy Issue C62805; FDA 1675
      • Filtration Issue C62986; FDA 2941 - Issue associated with the process of passing a substance through a porous medium, e.g., a blood clot filter for the removal of suspended matter.
        • Inadequate Filtration Process C62985; FDA 2308
        • Ultra-filtration C62827; FDA 1656 - Issue associated with the transfer of fluid between the blood and dialysate through the dialysis membrane due to a pressure gradient (trans-membrane pressure) existing between the blood and dialysate compartments.
      • Improper Flow or Infusion C63110; FDA 2954 - Issue associated with the unsubstantiated regulation and delivery of therapy, e.g., air, gas, drugs or fluids into a device or a patient under positive pressure that is being generated by a pump.
        • Bleed Back C63290; FDA 1064
        • Free or Unrestricted Flow C63130; FDA 2945 - Issue associated with uncontrolled flow of infusion of air, gas or fluids.
        • Gradient Increase C63126; FDA 1270 - Issue associated with the increased rate of change in temperature, pressure, or other variables as a function of distance, time, etc.
        • Inaccurate Delivery C63104; FDA 2339
          • Inaccurate Dispensing C63103; FDA 2955
        • Inaccurate Flowrate C63102; FDA 1249
        • Intermittent Infusion C63067; FDA 2341
        • Reflux within Device C62854; FDA 1522 - Issue associated with a backward or return flow.
        • Restricted Flowrate C62849; FDA 1248
        • Tidal Volume Fluctuations C63138; FDA 1634 - Issue associated with the amount of gas that is inspired and expired during one respiratory cycle.
      • Inflation Issue C63076; FDA 1310 - Issue associated with the inability of a device and/or device components to expand or enlarge with the intended inflation agent (e.g. saline or air)
      • Insufficient Flow or Underinfusion C62823; FDA 2182 - Issue associated with an under-dose of intravenous therapy, i.e., drugs or fluids being delivered into a patient under positive pressure generated by a pump.
      • No Flow C62902; FDA 2991 - Issue arising from the device failing to deliver the specified liquid or gas.
        • Failure to Deliver C63186; FDA 2338
        • Failure to Infuse C63174; FDA 2340
        • Inability to Irrigate C63105; FDA 1337
      • Obstruction within Device C62897; FDA 2423
        • Occlusion within Device C62896; FDA 1423 - Issue associated with an obstruction or blockage within any of the device components (e.g. tube, opening, pipe) that results in a restriction of flow.
          • Blockage within Device or Device Component C63289; FDA 1065
          • Device Clogged C63024; FDA 1094
          • Difficult to Flush C63317; FDA 1251
      • Pressure Issue C62934; FDA 3012 - Issue associated with the application of a force either internal of external to the device that compromises the flow of fluid or gas.
        • Decrease in Pressure C63255; FDA 1490
        • Increase in Pressure C63080; FDA 1491
        • No Pressure C64243; FDA 2994
      • Pumping Issue C62860; FDA 3016 - Issue associated with pump performance deviating from specifications in a way to compromise flow or infusion
        • Decreased Pump Speed C63252; FDA 1500
        • Failure to Pump C63165; FDA 1502
        • Increased Pump Speed C63077; FDA 1501
        • Pre- or Post-Pumping Problem C62867; FDA 1477
        • Pumping Stopped C62859; FDA 1503
      • Suction Issue C62833; FDA 2170 - Issue associated with suction equipment, which may be a manual, electrical, vacuum or pressure source operated to evacuate and remove undesired substances (air, gas, fluid, or particulates via tubing and collection bag.
        • Aspiration Issue C63299; FDA 2883
        • Decrease in Suction C63254; FDA 1146 - Issue associated with the removal by suction of excess fluid or gas from a body cavity.
        • Increase in Suction C63079; FDA 1604
    • Output Issue C62941; FDA 3005 - Issue associated with any deviation from device documented performance specifications relating to the end result, data, or test results provided by the device.
      • Improper Device Output C63108; FDA 2953 - Issue associated with the measurements/values/data obtained from the device being different from displayed, printed, stored, or exported measurements/values/data.
        • False Device Output C63150; FDA 1226
        • Image Orientation Incorrect C62887; FDA 1305 - Issue associated with an incorrect image orientation on the device display.
          • Image Reversal C63115; FDA 1358
        • Improper Gas Output C63109; FDA 1266
        • Inappropriate Prompts C63094; FDA 2280
          • Inaudible Voice Prompts C63092; FDA 2283
          • No Voice Prompts C62899; FDA 2282
        • Incorrect Display C63088; FDA 1184 - Issue associated with device failure and malfunction when device does not display adequate results or have proper display.
          • Erratic Display C63207; FDA 1182
          • Image Display Error C63117; FDA 1304 - Event in which measurement functions produce erroneous results or the image display is corrupted.
          • Issue with displayed error message C76129; FDA 2967 - Issue associated with error messages that are undecipherable or which fail to prompt the user toward appropriate corrective action.
          • Unable to Obtain Readings C62826; FDA 1516
        • Output above Specifications C62943; FDA 1432
          • Radiation overexposure C72892; FDA 3017 - Issue associated with excessive radiation emitted from radiological or diagnostic devices.
        • Output below Specifications C62942; FDA 3004
          • Radiation underexposure C72893; FDA 3018 - Issue associated with too little radiation emitted from radiological or diagnostic devices. Results in insufficient production of normal image contrast.
        • Output Energy Incorrect C63002; FDA 1431
          • Energy Output to Patient Tissue Incorrect C63001; FDA 1209
          • Energy Spectrum Incorrect C63000; FDA 1210
          • Failure to Deliver Energy C63184; FDA 1211
        • Poor Quality Image C62869; FDA 1408 - Issue associated with an image or any visual representation displayed by the device with non-distinctive characteristics.
          • Image Resolution Poor C62871; FDA 1306
        • Therapeutic or Diagnostic Output Failure C62828; FDA 3023 - Issue associated with the failure of the device to deliver any end results relating to treatment or identification of a disease.
      • Incorrect or Inadequate Result C62848; FDA 1535 - Issue associated with a nonconforming end result, data, or test results provided by the device to its performance specifications.
        • Display Misread C63221; FDA 1181 - Issue associated with not correctly reading the patient or test result information provided by the device.
        • False Negative Result C63149; FDA 1225 - Issue associated with the device incorrectly reporting that something has not been detected and misleads the operator into not taking certain actions when action should be taken.
        • False Positive Result C63147; FDA 1227 - Issue associated with the device incorrectly reporting that something has been detected and misleads the operator to take certain actions.
        • False Reading from Device Noncompliance C63145; FDA 1228 - Issue associated with the noncompliance of the device to meet its specific performance characteristics thereby causing a false reading.
        • High Readings C63123; FDA 2459
        • Incorrect Measurement C63085; FDA 1383
        • Incorrect or Inadequate Test Results C62829; FDA 2456
          • Artifact C63300; FDA 1036 - Issue associated with impurities or interference in a signal or image (e.g. ECG artifact).
          • High Test Results C63122; FDA 2457
          • Low Test Results C63045; FDA 2458
          • Missing Test Results C95878; FDA 3267 - Issue associated with the results of a test or measurement not appearing.
        • Low Readings C63046; FDA 2460
        • Unexpected Therapeutic Results C62821; FDA 1631 - Issue associated with the use of a medical device for therapeutic purposes.
      • No Device Output C62900; FDA 1435 - Issue associated with no measurement outcome, value, or data obtained from the device.
        • No Display or Display Failure C62904; FDA 1183 - Issue associated with the absence of visual indicator.
    • Protective Measure Issue C62932; FDA 3015 - Issue associated with any deviations from device documented performance specifications relating to the implemented and inherited design features specific to devices used for reducing risks to patient or caregiver or maintaining risks within specified levels.
      • Device Alarm System Issue C63033; FDA 1012 - Issue associated with electrical equipment or a system that detects alarm conditions (a state of the alarm system when it has determined that a potential or actual hazard exists) and, as appropriate, generates alarm signals.
        • False Alarm C63152; FDA 1013 - Issue associated with device providing incorrect alarm warning or alert to user.
        • Improper Alarm C63112; FDA 2951
          • Alarm not Visible C63309; FDA 1022
          • Defective Alarm C63251; FDA 1014
          • Delayed Alarm C63247; FDA 1011
          • Low Audible Alarm C63049; FDA 1016
          • Not Audible Alarm C63310; FDA 1019
      • Fail-Safe Mechanism Issue C62997; FDA 2936
        • Fail-Safe Design Failure C63199; FDA 1222 - Issue associated with safety features malfunctioning in such a way that results in harm to the patient or device operator.
        • Failure of device to Self-Test C62989; FDA 2937 - Issue associated with the device failing to perform an internal self-diagnostic process to ensure normal operation during or prior to use.
        • No Fail-Safe Mechanism C62903; FDA 2990
      • Failure to Auto Stop C62995; FDA 2938 - Issue associated with the inability of a device to turn itself off when the device is not in an operable condition.
        • Plunge C62873; FDA 1462
      • Premature Indicator Activation C62865; FDA 3011
        • Premature Elective Replacement Indicator C63315; FDA 1483
        • Premature End-of-Life Indicator C63320; FDA 1480
      • Reset Issue C62852; FDA 3019 - Issue associated with setting a variable, register, or other storage location back to a prescribed state.
        • Failure to Reset C62991; FDA 1532
        • Failure to Zero C62987; FDA 1683
        • Inappropriate or Unexpected Reset C63031; FDA 2959
      • Shielding Failure C62842; FDA 1568 - Issue associated with device inability to act as a barrier for absorption of radiation energy in X-rays, gamma rays, etc.
  • Facilities Issue - LEVEL 1 - Issue associated with the physical establishment and environment in which medical devices are transported, stored, processed, serviced or used within the user facility
    • Device Maintenance Issue C62977; FDA 1379 - Issue associated with the servicing of a device.
      • Failure to Service C62928; FDA 1563 - Issue associated with the lack of periodic preventative maintenance or performance assurance checks.
      • Inadequate Service C63098; FDA 1564 - Issue associated with inadequate periodic preventative maintenance or performance assurance checks.
      • Lack of Maintenance documentation or Guidelines C72671; FDA 2971 - Issue associated with user facility not receiving adequate service documentation, guidelines, or recommendations to perform preventative and corrective maintenance and performance assurance checks.
      • Maintenance Does not comply to Manufacturers Recommendations C62978; FDA 2974 - Issue associated with the noncompliance or nonperformance to manufacturer specifications relating to device routine maintenance, i.e., periodic inspection, failure detection, repair, and care of the device to sustain or restore acceptable operating conditions.
    • Disinfection or Sterilization Issue at User Location C63276; FDA 2895 - Issue associated with the undesired introduction of impurities to a device, or the insufficient removal of any visible soil, foreign material or organism deposits on the external surfaces, crevices, and joints of a device by a mechanical and/or manual process intended to render the device sterile, safe for handling, and/or for further processes to decontaminate. This issue is restricted to happening at the location where the device is used as opposed to during manufacturer or shipping.
      • Contamination During Use C63018; FDA 1120 - Issue associated with the undesired introduction of impurities either chemical or microbiological in nature, or of foreign matter into or onto the device at the user facility.
        • Contamination of Device Ingredient or Reagent C63266; FDA 2901
        • Device Contamination with Biological Material C63017; FDA 2908
          • Bacterial Contamination of Device C63297; FDA 2303
            • Biofilm Coating in Device C63293; FDA 1062
          • Device Contamination with Blood or Blood Product C63016; FDA 2317
        • Foreign Material Present in Device C63133; FDA 2944 - Issue associated with the presence of materials, which are not part of the documented device specifications and requirements.
      • Device Cleaning Issue C63099; FDA 1091 - Issue associated with the insufficient removal of unwanted visible soil, foreign material or organism deposits on the external surfaces, crevices, joints of a device by a mechanical and/or manual process intended to render the device sterile, safe for handling, and/or for further processes to decontaminate.
        • Device Disinfection or Sterilization Issue C63008; FDA 2909
          • Failure to Disinfect C63179; FDA 1175
          • Failure to Sterilize C63156; FDA 1596
        • Device Rinsing IssueC63107; FDA 2309
          • Failure to Flush C63176; FDA 1252
          • Failure to Remove Enzymatic Cleaner C63163; FDA 1213
        • Residue after Decontamination C62850; FDA 2325 - Issue associated with the decontamination process not adequately removing unwanted visible soil, foreign material, or organism deposits.
    • Environmental Control or Utility Issue C63209; FDA 2929 - Issue associated with the surrounding conditions in which the device is being used such as temperature, noise, lighting, ventilation, or other external factors such as power supply.
      • Ambient Noise Issue C63308; FDA 2877 - Issue associated with any undesired acoustic energy or vibration that tends to interfere with the operation of the device.
      • Ambient Temperature Issue C63307; FDA 2878 - Issue associated with compromised device performance at the ambient room temperature
        • Changes in Ambient Temperature in Device Environment C63282; FDA 1027
      • Biological Environmental Factor C63292; FDA 2887
        • Fungus in Device Environment C63128; FDA 2316 - Issue associated with the visibility of molds, mildews, yeasts, and/or mushrooms in the immediate environment in which a device is being used.
      • Device Expiration Issue C62998; FDA 1216 - Issue associated with the expiration date or shelf life of a product.
        • Expiration Date Error C62999; FDA 2528 - Issue associated with errors in identification of expiration date.
        • Shelf Life Exceeded C62926; FDA 1567 - Issue associated with the using a device after the marked or known shelf life.
      • Device Unsafe to Use in Environment C73118; FDA 2918
      • Electrical Power Problem C63217; FDA 2925 - Issue associated with the quality of the facility-supplied power.
        • Emergency Power Failure C63212; FDA 1205 - Issue associated with the failure of the facility's emergency power backup system(s) including generators and/or interruptible power systems (UPS).
        • Loss of Power C63052; FDA 1475 - Issue associated with the failure of primary power supplied by the facility.
        • Power Conditioning Issue C62868; FDA 1474 - Issue associated with a momentary overpower/over voltage from the utility and electrical systems of user facilities; - Issue associated with inadequate power conditioning such as the presence of fluctuation, surges, spikes, dropouts, noise and other such undesirable transients.
      • Environmental Particulates C72674; FDA 2930 - Issue associated with fine solids or liquid particles such as dust, smoke, fume, and/or mist suspended in the immediate atmosphere in which the device is being used.
      • Inadequate Lighting C62870; FDA 2957 - Issue associated with an inappropriate level of light or illumination in the immediate environment in which the device is being used or stored.
      • Medical Gas Supply Problem C72887; FDA 2985 - Issue associated with the facility-supplied medical gases such as medical air, oxygen, nitrous oxide, and nitrogen.
      • Moisture or Humidity Problem C62909; FDA 2986 - Issue associated with an unsatisfactory humidity level in the storage or use environment which affects device performance.
        • Moisture Damage C62910; FDA 1405 - Issue associated with damage inflicted upon the device or device components from water vapor or water in the immediate environment in which the device is being used.
      • Ventilation Issue in Device Environment C62807; FDA 3027
        • Fogging C63135; FDA 1253 - Issue associated with the visibility of water vapor in the immediate atmosphere in which the device is being used.
        • Fumes or Vapors C63129; FDA 2529 - Issue associated with the visibility, odor, or toxicity of an ambient vapor or gas which affects the operation of the device.
    • Inadequate Storage C63095; FDA 1600 - Issue associated with inadequate or inappropriate storage of the device, not otherwise described.
    • Installation-Related Problem C63074; FDA 2965 - Issue associated with unsatisfactory installation, configuration, and/or setup of a specific device or technology.
  • Human Factors Issue - LEVEL 1 - Issue associated with the interaction and interfacing between devices and users in terms of users' abilities, expectations, and limitations with work environments and system design.
    • Human-Device Interface Issue C76121; FDA 2949
      • Device Difficult to Maintain C79146; FDA 3134
      • Device Difficult to Setup or Prepare C63010; FDA 1487 - Issue associated with the use of the device in terms of user experiencing difficulty in preparing the device for use, even if the operation is being performed according to labeled instructions for use.
      • Difficult to Program or Calibrate C64339; FDA 1496 - Issue associated with the user's ability to cause device settings or actions to change to the state desired by the user.
      • Inadequate User Interface C63100; FDA 2958 - Issue associated with the means by which the operator and the equipment communicate or interact.
    • Inadequate Training C73117; FDA 1643 - Issue associated with facility not providing satisfactory initial and/or periodic user training covering operation of the device
    • Instruction for Use Issue C63072; FDA 1318 - Issue associated with the accuracy and appropriateness of any written, printed, graphic or audio/visual matter that is supplied with a medical device or its containers, wrappers; with any matter that accompanies a medical device including instructions related to identification, technical description and use of the medical device provided by the device manufacturer.
      • Inadequate instructions for healthcare professional C63087; FDA 1319 - Issue associated with inaccuracies in any written, printed, or graphic matter that is affixed to a medical device or its containers, wrappers; with any matter that accompanies a medical device including verbal instructions related to identification, technical description and use of the medical device provided by the device manufacturers.
      • Inadequate instructions for non-healthcare professional C63267; FDA 2956 - Issue associated with users being unclear and not able to follow any written, printed, or graphic matter that is affixed to a medical device or its containers, wrappers; with any matter that accompanies a medical device including verbal instructions related to identification, technical description and use of the medical device provided by the device manufactures that vary from the standard of medical care in a given environment.
    • Use of Device Issue C63318; FDA 1670 - Issue associated with the user's failure to process, service, or operate the device according to the manufacturer's recommendations or recognized best practices.
      • Device Handling Issue C95879; FDA 3265 - User handling not in accordance with specification.
      • Improper or Incorrect Procedure or Method C62862; FDA 2017 - Issue associated with the use of the device in terms of nonconforming to that device's intended use, specifications, procedure and process or service instructions and information provided by the device manufacturers.
      • Misassembled by Users C79147; FDA 3133
      • Use of Incorrect Control Settings C63264; FDA 1126 - Issue associated with the use of the device in terms of inappropriate and false control setting for the device's specified operation and/or intended use.
      • User used incorrect product for intended use C63082; FDA 1494
  • Physical Property Issue - LEVEL 1 - Issue associated with any deviations from specifications relating to device physical properties in terms of material integrity, mechanical, manufacturing/shipping, communication/transmission, optical, temperature, chemical, and electronic issues.
    • Chemical Issue C62945; FDA 2893 - Issue associated with any deviations from device documented performance specifications relating to any chemical characterization, i.e., element, compound, or mixture.
      • Chemical Spillage C63278; FDA 2894 - Issue associated with unintentional pouring out or releasing of chemical substances.
      • Device Emits Odor C63004; FDA 1425
      • Device Ingredient or Reagent Issue C62982; FDA 2910
        • Biocompatibility Issue C63294; FDA 2886
        • High pH C62981; FDA 2426
        • Sediment, Precipitate or Deposit in Device or Device Ingredient C62845; FDA 3021
          • Clumping in Device or Device Ingredient C63275; FDA 1095 - Issue associated with the aggregation of particles into irregular masses.
          • Coagulation in Device or Device Ingredient C63274; FDA 1096 - Issue associated with the undesired characterization of congealing, solidifying, thickening, curdling.
          • Cross Reactivity C63261; FDA 1137 - Issue associated with the degree to which an antibody or antigen participates in cross reactions.
          • Particulates C62879; FDA 1451 - Substances that consist of separate particles that are introduced by the device during use.
          • Precipitate in Device or Device Ingredient C62866; FDA 1478 - Issue associated with the separation of solid particles from a liquid as the result of a chemical or physical change.
      • Flashpoint Threshold Met C63139; FDA 2943 - Issue associated with approaching certain temperatures at which a combustible liquid ignites.
      • Improper Chemical Reaction C63111; FDA 2952 - Issue associated with an unexpected or inappropriate chemical reaction or effect.
    • Communication or Transmission Issue C63271; FDA 2896 - Issue associated with the device sending or receiving signals or data. This includes transmission among internal components of the device and other external devices to which the device is intended to communicate.
      • Failure to Read Input Signal C63164; FDA 1581
      • Failure to Transmit Record C63155; FDA 1521
      • Radio Signal Problem C62856; FDA 1511 - Issue associated with the wireless transmission signal in the lowest range of the electromagnetic spectrum.
      • Telemetry Discrepancy C62830; FDA 1629 - Issue associated with variability of the transmission of signals, which can be characterized as telemetry channel coding, a method of processing data sent from a source to a destination so that distinct messages are created which are easily distinguishable from one another.
      • Wireless Communication Issue C104820; FDA 3283 - Issue related to the transmission and reception of wireless medical device signals and data and the effects on the safety, effectiveness and functions of the medical device. These include issues related to wireless transmission and reception such as data integrity, timeliness, and reliability of transmitted signals and data. It can include issues with the RF wireless technology characteristics and performance (e.g., frequency, output power, range, reception), wireless quality of service, wireless coexistence, security of wireless signals and data, and electromagnetic compatibility.
    • Electronic Property Issue C63005; FDA 2928 - Issue associated with any deviations from device documented performance specifications relating to devices, circuits, or systems utilizing electrons and in association with components to convert, control and condition of electric power (alternating or direct current), and of voltage and current.
      • Arcing C63301; FDA 2583 - Issue associated with electrical current flowing through a gap between two conductive surfaces, typically resulting in a visible flash of light.
        • Arcing at Electrodes C63303; FDA 2289
        • Arcing at Paddles C63302; FDA 1032
      • Circuit Failure C63277; FDA 1089 - Issue associated with a failure of the internal network paths or electrical circuitry (i.e. electrical components, circuit boards, wiring)
        • Capacitive Coupling C63283; FDA 1079
        • Electrical Shorting C63216; FDA 2926
        • Intermittent Continuity C63068; FDA 1121
      • Electrical Overstress C63218; FDA 2924 - Issue associated with an electrical activity that exceeded the specified threshold limit of the internal integrated circuitry.
      • Electromagnetic Compatibility Issue C63215; FDA 2927 - Issue associated with the ability of a system to function in its electromagnetic environment without introducing intolerable disturbances to anything in its environment.
        • Electromagnetic Interference (EMI) C63214; FDA 1194 - Issue associated with a measure of electromagnetic radiation from equipment.
        • Electro-Static Discharge C63213; FDA 2149 - Issue associated with the discharge of electricity between two bodies previously electrically charged.
        • Radiofrequency Interference (RFI) C62855; FDA 2314 - Issue associated with the degradation of the reception of a wanted signal caused by RF disturbance.
      • Failure to Shut Off C62988; FDA 2939 - Issue associated with the device not powering off when a shut down was requested.
        • Device Remains Activated C62931; FDA 1525 - Issue associated with the device continuing to be in an active state after deactivation was requested.
      • Impedance Issue C63114; FDA 2950 - Issue associated with electrical impedance levels between device components or device and patient connections
        • High Impedance C63124; FDA 1291 - Issue associated with higher than intended electrical impedance levels between device components or device and patient connections
        • Low Impedance C63047; FDA 2285 - Issue associated with lower than intended electrical impedance levels between device components or device and patient connections.
      • Spark C62837; FDA 2595 - Issue associated with a flash of light related to an electrical discharge in an unexpected location.
    • Manufacturing or Shipping Issue Associated with Device C63041; FDA 2975 - Issue associated with any deviations from device documented performance specifications relating to nonconformity during manufacture to the design of an item or to specified manufacturing processes.
      • Component Missing C63021; FDA 2306 - Issue associated with the absence of any part, substance, software, hardware, or raw material that is designed to be put together as part of the finished device or product.
      • Device Markings Issue C62976; FDA 2911 - Issue associated with the written, printed or graphic material that is affixed to a medical device or any of its containers or wrappers or accompanying the device including verbal instructions, relating to identification, technical description, and usage which are provided by the device manufacturers. Issue can include but is not limited to this material being unclear, missing worn out, incorrect or inaccurate.
      • Defective Item C63250; FDA 2588 - Issue associated with having flaws or dimensional deviations greater than acceptable for the intended use of the device.
        • Defective Component C63023; FDA 2292 - Issue associated with a device component having flaws of dimensional deviations greater than acceptable for the intended use.
      • Device Damaged Prior to Use C63015; FDA 2284
        • Shipping Damage or Problem C62925; FDA 1570
      • Device Misassembled during Manufacturing or Shipping C62957; FDA 2912
      • Incorrect Device or Component Shipped C63084; FDA 2962 - Issue associated with the delivery of an inappropriate device or device component to a user facility.
      • Item Contaminated during Manufacturing or Shipping C63019; FDA 2969 - Issue associated with the presence of any unexpected foreign substance found on the surface or in the package materials, which may affect optimal performance for its intended use.
        • Delivered As Unsterile Product C63014; FDA 1421 - Issue associated with the device being received in such a manner to indicate that its sterility has been compromised (e.g. sterile packaging breached, visible contaminate present)
      • Packaging Issue C62939; FDA 3007 - Issue associated with the materials used to construct the cover or outer wrapping of the device.
        • Device Packaging Compromised C63240; FDA 2916 - Issue associated with the nonconformance to device specifications and minimum packaging requirements as the device may not be operating and functioning as intended.
          • Incomplete or Missing Packaging C62940; FDA 2312
          • Tear, Rip or Hole in Device Packaging C62831; FDA 2385
          • Unsealed Device Packaging C62810; FDA 1444
        • Difficult to Open or Remove Packaging Material C63231; FDA 2922 - Issue associated with difficulty for end-users to operate device, specifically as it relates to the opening or removal of the outer wrapping.
          • Failure to Unwrap C63154; FDA 2940 - Issue associated with problems removing the materials used to construct the cover or outer wrapping of the device.
      • Product Quality Issue C62948; FDA 1506 - Issue associated with an inherent device and/or device component characteristic that is not satisfactory as specified or delivered
        • Dull C63219; FDA 2407
        • Nonstandard Device or Device Component C62898; FDA 1420 - Issue associated with a material that does not meet the specifications or requirements for which it was manufactured, and has not been subjected to use or processing other than that required for its initial manufacture.
        • Out-Of-Box Failure C62944; FDA 2311
    • Material Integrity Issue C62968; FDA 2978 - Issue associated with any deviations from device documented performance specifications relating to the limited durability of all material used to construct the device.
      • Break C62973; FDA 1069 - Issue associated with undesired damage or breakage of those materials used in device construction.
        • Fracture C63132; FDA 1260 - Issue associated with a partial or full-thickness crack in the device materials.
        • Loss of or Failure to Bond C63194; FDA 1068 - Issue associated with lack or loss of adherence between materials intended to be joined together by an adhesive.
          • Solder Joint Failure C62838; FDA 2324
        • Material Fragmentation C62969; FDA 1261 - Issue associated with small pieces of the device breaking off unexpectedly
      • Buckled Material C63287; FDA 2889 - Issue associated with an undesired bulge, bend, bow, kink, or wavy condition observed in the device material resulting from compressive stresses.
      • Burst C62972; FDA 1074 - Issue associated with the pressure inside a vessel or container rising to such a degree that the container ruptures.
      • Crack C62971; FDA 1135 - Issue associated with an undesired separation and/or a visible opening along the length or width in the materials that are used in device construction.
      • Degraded C62970; FDA 1153 - Issue associated with a deleterious change in the chemical structure, physical properties, or appearance in the materials that are used in device construction.
        • Calcified C63285; FDA 1077 - Issue associated with buildup of calcium salts on the device or its components.
        • Corrosion C63263; FDA 1131 - Issue associated with the chemical or electrochemical reaction between materials, usually a metal and its environment that produces a deterioration of the metal and its properties.
        • Flaked C63141; FDA 1246 - Issue associated with the detachment of small pieces of the coating film of a material.
        • Material Erosion C63208; FDA 1214 - Issue associated with a progressive loss of a material from a solid surface.
        • Naturally Worn C62906; FDA 2988 - Issue associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.
        • Peeled C62878; FDA 1454 - Issue associated with stresses of sufficient magnitude to exceed the strength of adhesion between the device material and its coating, i.e., insulation pulling away from a wire, label peeling off.
          • Delamination C50433; FDA 2904 - Issue associated with peeling of composite materials. Occurs when layers are separated as a result of continuous stress or impact. Results in loss of mechanical toughness.
        • Pitted C62874; FDA 1460 - Issue associated with the corrosion of a material's surface, confined to a point or small area that takes the form of cavities.
        • Unraveled Material C62811; FDA 1664
      • Material Deformation C63248; FDA 2976 - Issue associated with an undesired material change in shape or property caused by external forces.
        • Dent in Material C63245; FDA 2526
        • Failure to Fold C63175; FDA 1255
        • Failure to Unfold or Unwrap C62949; FDA 1669 - Issue associated with the comprising materials' deformation in that a device fails to open its wrapping or open/extend to a certain fashion or form i.e. balloon or lens.
        • Material Frayed C63131; FDA 1262 - Issue associated with the comprising materials having damaged edges.
        • Material Invagination C63063; FDA 1336
        • Material Rigid or Stiff C62847; FDA 1544
        • Material Twisted C62962; FDA 2981
          • Bent C63296; FDA 1059
            • Folded C63134; FDA 2630
            • Kinked C63060; FDA 1339
            • Wrinkled C62804; FDA 2614
          • Coiled C63273; FDA 1098
          • Knotted C63059; FDA 1340
          • Material Torqued C64340; FDA 2980 - Issue associated with a movement of forces that produces or tends to produce rotation or torsion of a material.
          • Uncoiled C62825; FDA 1659
        • Melted C62908; FDA 1385 - Issue associated with a solid device or device components being transformed into a molten or liquid state
        • Mushroomed C62907; FDA 2987
        • Stretched C62835; FDA 1601 - Issue associated with an increase or elongation in a materials' dimension.
      • Material Discolored C63224; FDA 1170 - Issue associated with an undesired streak, pattern, and/or a noticeable change in color from the rest of the materials used in device construction.
      • Material Disintegration C63222; FDA 1177 - Issue associated with material breaking into small fragments or particles
        • Metal Shedding Debris C62918; FDA 1804
      • Material Distortion C72894; FDA 2977 - Issue associated with undesired physical appearance of device material resulting from excessive stress or impact.
      • Material Perforation C62967; FDA 2205 - Issue associated with an undesired material damage characterized by closely spaced punched or drilled holes.
        • Cut in Material C63260; FDA 2454
        • Hole in Material C63120; FDA 1293 - Issue associated with an opening not characteristic of the normal material.
        • Material Puncture C62966; FDA 1504 - Issue associated with the comprising material(s) being penetrated, pierced or punctured, especially with a sharp or pointed object.
        • Material Rupture C62965; FDA 1546 - Issue associated with the bursting or tearing apart of a material.
      • Material ProtrusionC72891; FDA 2979 - Issue associated with undesired physical appearance of device material, specifically when material extends beyond or above the device surface.
      • Material Opacification C62895; FDA 1426 - Issue associated with an undesirable opaqueness or cloudiness.
      • Material Separation C62964; FDA 1562 - Issue associated with an undesired disassociation or breaking apart of device materials
      • Scratched Material C62846; FDA 3020 - Issue associated with an undesirable shallow cut or narrow groove in the surface of the device materials.
        • Device Abrasion from Instrument or another Object C63037; FDA 1387
      • Split C62963; FDA 2537 - Issue associated with an undesired tearing of the material membrane that may be due to exceeding the tensile stress limits belonging to the materials used in device construction.
      • Torn Material C62832; FDA 3024 - Issue associated with comprising material(s) being pulled apart or into pieces by force, wrenching, or laceration.
    • Mechanical Issue C62961; FDA 1384 - Issues associated with any deviations from device documented performance specifications relating to mechanical defects, including moving parts or subassemblies, etc.
      • Delivery System Failure C63246; FDA 2905
      • Detachment of Device or Device Component C63242; FDA 2907 - Issue associated with the separation of the device and/or device components from its physical construct, integrity, or chassis.
        • Detachment of Device Component C63243; FDA 1104 - Issue associated with the unintentional separation of the device and/or its components from something to which it is connected or attached.
        • Disassembly C63225; FDA 1168
      • Device or Device Component Damaged by another Device C62951; FDA 2915 - Issue associated with one device and/or device component causing harm to another device and/or component
      • Dislodged or Dislocated C62950; FDA 2923 - Issue associated with mechanical force that displaces device and/or device components from an intended location.
        • Component Falling C63153; FDA 1105 - Issue associated with an undesirable descent of a device component due to the force of gravity, usually from a higher to a lower level, usually the ground or floor.
        • Device or Device Fragments Location Unknown C63038; FDA 2590
        • Escape C63204; FDA 2931
          • Tip-over C62921; FDA 2589
        • Slippage of Device or Device Component C62840; FDA 1584
      • Leak C63058; FDA 1354 - Issue associated with the escape of a liquid or gas from the vessel or container in which it is housed.
        • Fluid Leak C63137; FDA 1250
          • Hot Oil Leak C63119; FDA 1298
          • Peri-valvular Leak C62876; FDA 1457 - Issue associated with the escape of blood around a heart valve, particularly around its leaflets.
          • Strikethrough C62834; FDA 2538
        • Gas Leak C63127; FDA 2946 - Issue associated with the unintended escape of a gas from the container in which it is housed.
          • Air Leak C63311; FDA 1008
        • Gel Leak C63316; FDA 1267
        • Radiation Leak C62857; FDA 1357
      • Mechanical Jam C63039; FDA 2983 - Issue associated with a problem that prevents or restricts the motion of the device or its components.
        • Looping C63056; FDA 1370
      • Mechanics Altered C62960; FDA 2984 - Issue associated with device mechanical functioning of machinery, moving parts or tools of the device being changed or modified.
        • Failure to Align C63197; FDA 2522 - Issue associated with a circuit, equipment, or system whereby its functions fail to be properly synchronized or its relative positions properly oriented.
        • Failure to Cut C63188; FDA 2587
        • Failure to Cycle C63187; FDA 1142 - Issue associated with the device failing to complete a series of processes or events
        • Failure to form staple C64328; FDA 2579
      • Misfire C62914; FDA 2532 - Issue associated with failure of device to discharge its load (e.g. surgical stapler failed to partially or completely deploy its staples)
      • Noise, Audible C99179; FDA 3273 - Issue associated with any unintended sound which emanates from a device (for example, squeaking from two parts rubbing together or buzzing sounds from electrical components).
      • Osseointegration Issue C62886; FDA 3003 - Issue associated with interconnection between bone tissue and implanted device.
        • Failure to Osseointegrate C63171; FDA 1863 - Issue associated with the failure to see direct anchorage of an implant by the formation of bony tissue around the implant without the growth of fibrous tissue at the bone-implant interface.
        • Loss of Osseointegration C63053; FDA 2408
      • Positioning Issue C63034; FDA 3009 - Issue associated with the movement of the device and/or device components to an intended location.
        • Difficult to Advance C63235; FDA 2920 - Issue associated with difficulty moving the device or its components to an intended location (e.g. difficulty in advancing guidewire)
        • Difficult to Insert C63233; FDA 1316 - Issue associated with problems introducing or inserting the device, even if the user is operating the device in accordance with the instructions for use or labeling.
        • Difficult to Position C63230; FDA 1467 - Issue associated with the use of the device in terms of user experiencing difficulty to put device and/or device components in place, even if the operation is being performed according to labeled instructions for use.
        • Difficult to Remove C63228; FDA 1528 - Issue associated with the use of the device in terms of user experiencing difficulty to take out or get rid of a device and/or device components, even if the operation is being performed according to labeled instructions for use.
        • Entrapment of Device or Device Component C63210; FDA 1212 - Issue associated with the device and/or device accessories caught within patient vasculature, tissue, or other devices or device components.
        • Failure to Advance C63198; FDA 2524 - Issue associated with failure to move the device or its components to an intended location
        • Malposition of Device C63043; FDA 2616 - Issue associated with device being positioned in a location other than intended or specified.
        • Physical Resistance C62875; FDA 2578
        • Sticking C62836; FDA 1597
      • Retraction Problem C62929; FDA 1536 - Issue associated with drawing back the device and/or device component to an intended location.
      • Structural Problem C62923; FDA 2506 - Issue associated with the basic physical construction or physical make up of the device.
        • Collapse C63272; FDA 1099 - Issue associated with the buckling or crushing of material from external forces.
        • Difficult to Fold or unfold C63234; FDA 1254 - Issue associated with the use of the device in terms of user experiencing difficulty to close or to spread out/extend length of a device, even if the operation is being performed according to labeled instructions for use.
        • Difficult to Open or Close C63012; FDA 2921 - Issue associated with the use of the device in terms of user experiencing difficulty opening and closing the device, even if the operation is being performed according to labeled instructions for use.
        • Incomplete Coaptation C63090; FDA 2507 - Issue associated with the heart valve leaflet not closing properly.
      • Unintended Movement C62814; FDA 3026 - Issue associated with an undesired movement of device, which may be related to device malfunction, misdiagnosis, or mistreatment.
        • Migration of Device or Device Component C62917; FDA 1395 - Issue associated with an undesired movement of device and/or device components, related to its movement away from or dislodging from a source.
          • Expulsion C50554; FDA 2933 - Issue associated with the unintended ejection of device component materials.
        • Unintended Arm Motion C62820; FDA 1033
        • Unintended Collision C62819; FDA 1429 - Issue associated with device or device components impacting with another object.
        • Unintended Head Motion C62816; FDA 1284
        • Unintended System Motion C62813; FDA 1430 - Issue associated with any motion of the system or components that was not initiated by the user.
        • Unstable C62809; FDA 1667 - Issue associated with the connection of device and/or device components not possessing stability, or is unbounded.
        • Vibration C62806; FDA 1674 - Issue associated with an oscillation wherein the quantity is a parameter that defines the motion of a mechanical system.
          • Extrusion C50557; FDA 2934 - Issue associated with the unintended projection of device component materials.
    • Optical Issue C62953; FDA 3001 - Issue associated with problems transmitting visible light affecting the quality of the image transmitted or otherwise affecting the intended application of the visible light path.
      • Light Interference C63057; FDA 2972
      • Optical Decentration C62891; FDA 1360 - Issue associated with being off-center of optical lenses.
        • Misfocusing C62913; FDA 1401
      • Optical Discoloration C62890; FDA 2999 - Issue associated with an optical streak or other pattern on the signal surface that causes a noticeable change of color from the rest of the pultruded surface.
      • Optical Distortion C62889; FDA 3000 - Issue associated with an optical defect in an image-forming system whereby the image is not the shape of an ideal image of the object.
      • Optical Obstruction C62888; FDA 3002 - Issue associated with the blocking of optical devices, e.g., visual pathways.
    • Temperature Issue C62922; FDA 3022 - Issue associated with the device producing unintended temperatures (for issues related to environmental/ambient temperatures refer to code C63307)
      • Burn of Device or Device Component C63286; FDA 1071 - Issues associated with a discoloration or destruction as a result of thermal decomposition of the device or its components
        • Charred C63279; FDA 1086
      • Excessive Cooling C63202; FDA 2932 - Issue associated with the device or its components producing temperatures that are lower than specified.
      • Fire C63143; FDA 1245 - Issues associated with the combustion of device components, resulting in any of the following: light, flame, smoke.
      • Flare or Flash C63140; FDA 2942 - Issue associated with device-related burn with an unsteady flame.
      • Insufficient Cooling C63071; FDA 1130 - Issue associated with device or device parts being insufficiently cool in device active (working) or/and non-active nonworking) state.
      • Insufficient Heating C63070; FDA 1287 - Issue associated with the device or its components producing temperatures that are not as high as what is specified.
      • Overheating of Device or Device Component C62883; FDA 1437 - Issue associated with the device producing high temperatures, such that its operation is compromised (e.g. overheating that produces melting of components or automatic shutdown)
        • Unintended Magnet Quench C62815; FDA 1377
      • Smoking C63003; FDA 1585 - Issue associated with a cloud of vapor or gas generated from the device, generally associated after a fire or a burn.

Missing Value Reason - LEVEL 1

  • No Code Available C64343; FDA 3191
  • No Information C53269; FDA 3190
  • No Known Device Problem C76126; FDA 2993
  • Not Applicable C48660; FDA 3189