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U.S. Department of Health and Human Services

Medical Devices

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Evaluation Conclusion Code Hierarchy

Subset: Medical Device Evaluation Conclusions Terminology

  • CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS C91868; FDA 11 – LEVEL 1 - The device is undergoing an evaluation but has not yet been completed.
  • HUMAN FACTORS ISSUE C91874; FDA 19
    • DEVICE DIFFICULT TO OPERATE C91870; FDA 13 - Device problems including set-up, operation, and disassembly of equipment.
    • DEVICE FAILURE RELATED TO PATIENT CONDITION C91872; FDA 50 - A device problem that occurred in part or in total related to the patient's physiology.
    • DEVICE INCORRECTLY PREPARED FOR USE OR MODIFIED C91876; FDA 14 - A device that is incorrectly modified or prepared for use by distributor, service provider, or user facility.
    • FAILURE TO FOLLOW INSTRUCTIONS C91873; FDA 18 - A device problem related to the user not following the manufacturer's instructions.
    • OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO EVENT C91884; FDA 77 - A device problem related to the operator's technique or use environment.
    • USE ERROR CAUSED OR CONTRIBUTED TO EVENT C91895; FDA 61 - The interaction between the device and the user caused or contributed to the error. This includes inappropriate use of the device or failure to appropriately maintain the device.
  • INFRASTRUCTURE FAILURE C91877; FDA 21 - Device problems related to problems with the underlying framework, systems, and processes of an organization (e.g. as building power supply, network, oxygen systems).
  • KNOWN INHERENT RISK OF PROCEDURE C91878; FDA 22 - Device problems known and documented in the labeling (including both short or long term known complications or adverse reactions).
  • LABELING DEFICIENCY C91879; FDA 57 - Device problems that occur as the result of problems with the labeling (including package inserts, instruction manuals, instructions for use).
  • OFF-LABEL, UNAPPROVED, OR CONTRAINDICATED USE C91892; FDA 24 - Device problems related to its use during an unapproved procedure, in an unapproved patient, or for which it is contraindicated, or not listed on the label.
  • QUALITY SYSTEM DEFICIENCY C91885; FDA 25 - A defect in the processes or systems used in the design and manufacture of the device. Examples include problems within the change control, production, or quality control processes.
    • DESIGN DEFICIENCY C91869; FDA 12 - The device problem was traced back to the design specifications (e.g. in the requirements, testing processes, hazard analysis, implementation strategy).
    • DEVICE REPAIRED AND RETURNED C91888; FDA 63 - The device was repaired and returned to the user (reporter) following a reported device problem.
    • MAINTENANCE DEFICIENCY C91880; FDA 51 - Device problems that result from improper routine or preventative maintenance.
    • MANUFACTURING DEFICIENCY C91881; FDA 23 - The device problem was traced back to the manufacture of the device as opposed to systems used to control the manufacture of the device (quality system). Examples include problems with construction or assembly.
  • REUSE OF SINGLE USE DEVICE C91893; FDA 26 - Device problems related to the use of a device more than once when it is designed for only one use.
  • TRAINING DEFICIENCY C91889; FDA 27 - A device problem related to inadequate training.
  • UNABLE TO CONFIRM COMPLAINT C91894; FDA 67 - The device complaint or problem cannot be confirmed. If possible, choose a more specific reason from among the terms listed in this branch of the hierarchy.
    • CANNOT COMPLETE INVESTIGATION, INCOMPLETE DEVICE RETURNED C91867; FDA 10
    • DEVICE DISCARDED BY USER, UNABLE TO FOLLOW-UP C91871; FDA 70
    • DEVICE NOT MANUFACTURED BY REPORTING FIRM C91882; FDA 15
    • DEVICE NOT RETURNED C91883; FDA 92
    • DEVICE RECEIVED IN CONDITION MAKING EVALUATION IMPOSSIBLE C91886; FDA 94
    • DEVICE RECEIVED UNUSED IN ORIGINAL PACKAGE C91887; FDA 16
    • INCONCLUSIVE-INVESTIGATION IN PROGRESS C91875; FDA 20
    • NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION C91890; FDA 71
    • NO FAILURE DETECTED, DEVICE OUT OF SPECIFICATION C91891; FDA 75