Medical Devices

MEDWATCH Medical Device Reporting Code Instructions - Appendix D - Evaluation Results Code

 

Component / Subassembly Failures


A

401 Absorber (CO2) 411 Alarm, power
548 Accumulato 412 Alarm, pressure
402 Actuator 550 Alarm, self
431 Adapter 413 Alarm, visual
552 Air cleaner 414 Alarm, volumne
549 Air pump assembly 590 Alternator
403 Alarm 591 Altimeter
404 Alarm, assembly 592 Amplifier
405 Alarm, audible 593 Analyzer
407 Alarm, high inspiratory pressure 594 Annunciator
408 Alarm, LED 595 Antenna
409 Alarm, low inspiratory pressure 596 Arrester
410 Alarm, oxygen pressure 597 Attenuator

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B

598 Backpanel 737 Belt
599 Backplane 738 Blower
417 Bacterial filter 739 Bobbin
730 Baffle 740 Bolometer
553 Bags 741 Bolt
418 Ball 554 Bottom dead center sensor bracket
731 Ballast 742 Brake
419 Balloon 422 Breathing circuit
732 Barrier 743 Brush
420 Battery 745 Bus
733 Beam splitter 746 Bushing
734 Bearings 736 Buzzer
735 bell  

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C

423 Cable 558 Concentrator
747 Calibrator 559 Conductor coil
748 Camera 560 Connecting rod
749 Cannula, inner 435 Connector
750 Cannula, outer 764 Contact lens
424 Cap 436 Control switches
751 Capacitor 765 Controller
555 Capacitor (ceramic chip) 766 Converter
752 Carrier 767 Cooling module
556 Cascade 768 Cord
425 Cassette 769 Core
753 Caster 770 Counter
754 Cell 771 Coupler
426 Charger 772 Cover
755 Chassis 437 CPU (central processing unit) board
756 Choke 561 Crank arm assembly
427 Circuit board 438 CRT (cathode ray tube)
757 Clamp 773 Crystal
758 Clip 562 Cuff
759 Clock 563 Cup seal
428 CO2 monitor 774 Cups
429 CO2 monitor subassembly (only use when part of another device) 775 Current limiter
760 Coder 776 Current source
761 Coil 439 Cusp
762 Collimator 777 Cutter
763 Comparator 440 Cylinder
557 Compressor (air pump) 441 Cylinder valve

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D

778 Damper 445 Diaphragm
779 Data acquisition unit 790 Digitizer
780 Decoder 447 Diode
442 Defibrillator paddles 448 Discrete component/device (resistor, capacitor, diode)
443 Defibrillator subassembly (only use when part of another device) 791 Disk
781 Dehumidifier 416 Display
782 Dehydrator 792 Divider
783 Delay line 793 Dome
784 Demagnetizer 794 Doubler
785 Demodulator 795 Driver
786 Densitometer 796 Duct
787 Detector 797 Dummy load
788 Device deployer 798 Duplexer
789 Dial    

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E

450 EKG/ECG monitor 454 EPROM (erasable programmable read only memory)
449 EKG/ECG subassembly (only use when part of another device) 803 Equalizer
452 Electrical lead 804 Evaporator
451 Electrode 455 Exhalation filter
799 Emitter 805 Expander
800 Enclosure 806 Extender
801 Encoder 807 Extractor
802 Endoscope 808 Eyelet

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F

456 Fail-safe system 817 Flasher
809 Fan 458 Flowmeter
810 Fastener 818 Foil
811 Feedthru 819 Foot pedal
812 Ferrule 459 Foot switch
813 FET (field effect transistor) 820 Frame
814 Fiber 460 Function indicator
815 Film 564 Function lid
816 Filter 821 Furnace
457 Flange 822 Fuse

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G

461 Gas scavenging 826 Grille
823 Gasket 827 Grommet
462 Gauge/meters 828 Ground strap
824 Gear 829 Guide
565 Gears 463 Guidewire
825 Generator    

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H

830 Handset 467 Heater
464 Header 566 Heater rod
831 Headphone 567 Helifix coil
832 Heads 837 Hinge
833 Headset 838 Holder
465 Heart valve cage 468 Hollow fiber
466 Heart valve leaflet 839 Housing
834 Heart valve sewing ring 469 Hub
835 Heat exchanger 470 Humidifier
836 Heat sink 471 Hybrid circuit

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I

474 IC (integrated circuit) 846 Integrator
472 IC (integrated circuit) chip 847 Intercom
840 Igniter 569 Interconnection board intubate
841 Imager 848 Interface
842 Impedance converter 849 Interrupter
843 Indexer 850 Inverter
844 Indicator 851 IOL (introcular lens) implant
845 Inductor 852 Isolator
473 Insulation    

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J

853 Jack 856 Jumper
854 Joint 857 Junction
855 Joystick    

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K

475 Keyboard 860 Kit
858 Keyer 861 Knob
859 Keypad    

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L

862 Label 868 Line conditioner
863 Laminate 570 Line cord
864 Lamp 479 Lithium iodide battery
865 Laser 869 Load
476 Lead conductor 870 Lock
477 LED (light emitting diode) 571 Locking sleeve
866 Lenses 480 Logic board
478 Limit switch 572 Lower piston bearing
867 Limiter 481 Luer valve

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M

871 Magazine 880 Microphone
482 Magnet 881 Microscope
872 Magnetizer 882 Mirror
873 Magnetometer 883 Mixer
874 Magnetoresistor 884 Modem
875 Magnifier 885 Modulator
483 Manifold 886 Monitor
876 Matrices 485 Mother board
484 Membrane 486 Motor
877 Memory 574 Motor roll pin
878 Meter 887 Mount
573 Meter needle 888 Multiplier
879 Microcircuit    

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N

889 Nebulizer (only use when part of another device) 1023 None
890 Network 891 Nuts

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O

487 O2 monitor subassembly (only use when part of another device) 400 Other (code unspecified, describe in H10)
892 O2 sensor 898 Outlet
488 Obturator 899 Oven
894 Optical cable 575 Overlay
893 Optical disk 489 Oximeter
546 Optical Fiber 490 Oximeter (only use when part of another device)
895 Optocoupler 490 Oximeter analyzer
897 Oscilloscope    

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P

900 Pad 580 Power lamp
901 Panel 913 Power module
492 PC (printed circuit) board 498 Power supply
902 Photodetector 499 Power switch
903 Photomultiplier 914 Preamplifier
904 Phototransistor 915 Prescaler
905 Pickup 916 Preselector
493 Pilot balloon valve 500 Pressure sensor
906 Pin 581 Pressure signal
576 Piston guides 501 Pressure tubing
577 Piston heads 917 Printer
578 Piston Pads 918 Probe
494 Pivot 919 Processor
907 Plate 920 Programmer
908 Plotter 503 PROM (programmable read only memory)
579 Plug 504 Prong
910 Pointer 921 Protector
911 Polarizer 922 Proximity switch
495 Port 923 Pulley
912 Post 924 Pulser
496 Potentiometer 925 Pump
497 Power cord 926 Pyrometer

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R

927 Rail 936 Resolver
505 RAM (random access memory) 937 Resonator
928 Reactor 938 Retainer
929 Reader 583 Retaining pin
930 Receiver 939 Reticle
507 Recorder (tape, stripchart, etc) 940 RFI (radio-frequency interference)
931 Rectifier 941 Rheostat
582 Read (electrically open) 942 Ribbon
932 Regulator 943 Ring
508 Relay 944 Rivet
933 Repeater 945 Robot
934 Reservoir 946 Rod
935 Resistor 509 ROM (read only memory)

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S

947 Safety interlock 511 Solder joint
984 SAW (surface accoustic wave device) 512 Solenoid
949 Scale 968 Sound absorber
948 Scaler 969 Spacer
950 Scanner 970 Spark gap
951 Scintillometer 971 Speaker
952 Scrambler 972 Spectrometer
953 Screen 514 Spirometer
568 Screw 973 Splicer
954 Scriber 974 Spooler
432 Sceal 975 Spring
584 Seal tracheal 976 Stabilizer
510 Sensor 977 Stand
551 Servo 515 Stent
955 Shaft 516 Stepper motor
956 Shield 978 Stiffner
957 Shift register 517 Stopcock
958 Shifter 979 Strain relief
959 Shunt 980 Stip line
960 Shutter 518 Stylet
961 Signal conditioner 981 Substrate
962 Simulator 982 Sunlamp
963 Slide 983 Suppressor
964 Slip ring 519 Switches
965 Slotter line 985 Synchronizer
967 Socket 986 Synthesizer
966 Socket adapter 987 Syringe

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T

988 Table 1003 Thyristor
989 Tachometer 1004 Timer
990 Tape 586 Tip conductor coil
991 Tee 1005 Trackball
520 Telemetry equipment 1006 Transceiver
992 Telephone 522 Transducer
993 Teleprinter 523 Transformer
994 Teletypewriter 524 Transistor
995 Television unit 1007 Translator
996 Temperature compensator 1008 Transmission line
997 Terminal 1009 Transmitter
585 Terminal assembly 1010 Transponder
998 Termimator 1011 Transport
999 Thermistor 1012 TRIAC
1000 Thermocouple 1013 Trimmer
547 Thermocouple wire 525 Tube
1001 Thermometer 587 Tube capillary
1002 Thermostat 1014 Tuner

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U

444 User interface

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V

527 Valve 538 Valve, PEEP (positive and expriatory pressure)
528 Valve (one-way, stopcock, etc) 539 Valve, pressure limit
529 Valve, control 540 Valve, relief
530 Valve, directional 541 Valve, safety
589 Valve, dump 542 Valve, selector
531 Valve, exhaltion 543 Vaporizer
532 Valve, flap 1015 Varistor
533 Valve, flow 588 VDT (video display terminal)
534 Valve, inhalation 1016 Vibrator
535 Valve, inlet port 1017 Viewer
536 Valve, inspiratory 1018 Voltmeter
537 Valve, outlet port

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W

1019 Washer 430 Wire
1020 Waveguide 544 Wiring harness
1021 Window    

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Y

545 Y-piece connector 1022 Yoke

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Computer,Imaging System,Microprocessor-Controlled Device Problems


A

617 Algorithm analysis 618 Algorithm problem

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B

657 Bus conflicts 633 Bus Corruption

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C

652 Cache controller 663 Compression errors
653 cache memory; 603 Computer - user interface
635 Calculation error (pentium) 602 Computer hardware problem
601 Central processing unit/operating system-error/design 605 Computer software problem
643 Cold 616 Computer software problem - error/design
628 Communication 658 Conducted interference

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D

626 Data corruption 655 DMA controller (direct memory access)
631 Deadlock 646 Dust
647 Dirt    

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E

664 Electromagnetic 648 Electrostatic discharge

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G

630 Glitch    

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H

642 Heat 645 Humidity

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I

656 I/O (input/output)controller 637 Interrupt errors
627 I/O (input/output) integrity    

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K

621 Kernal    

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L

638 Latch-up 644 Liquid ingress

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M

606 Magnectic interference 629 Metastable state
607 Medical diagnosis software 608 Modem/communications failure
654 Memory access errors    

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N

665 None    

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O

600 Other (code unspecified,describe in H10)    

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P

609 Poor image resolution 662 Power sequencing
659 Power fluctuation 661 Power spike
610 Power loss/surge related complication 660 Power transient
    640 Power-up errors

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R

641 Radiation effects 639 Reset errors
622 Real-time operating system 611 RF interference

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S

612 Safety interlock/feature failure 636 Stack errors
625 Sequence processing 619 State machine
650 Shock    

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T

651 Temperature fluctuation 620 Token
634 Timing violation 632 Transmission effects

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U

613 User installation error 614 User maintenance error

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V

624 Vector processing 649 Vibration

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W

623 Watchdog

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Results of Evaluation Codes (ordered alphbetically within each category)


A

703 Alarms inadequate or absent

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C

101 Component/subassembly failure (select specific code from Category D) 105 Computer/human interface problem
103 Computer hardware problem 705 Controls, switches, keypads difficult to read or use
104 Computer software problem 704 Critical information not displayed

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D

110 Design (unspecified) 113 Design - user interface
115 Design - maintenance difficult 706 Device difficult to assemble or set up
112 Design - not fail safe 708 Device performed according to specifications
114 Design - operational context 702 Display hard to read or misleading
111 Design - packaging deficiencies    

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E

120 Electrical problem (unspecified) 198 Electro-static interference
122 Electrical problem - open circuit 133 End of life - expected
123 Electrical problem - operating outside specifications 134 End of life - premature
121 Electrical problem - short circuit 138 Exceeded expected life of device
197 Electro-magnetic interference problem 140 Expected wear/deterioration

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F

141 Failure to cycle 142 Foreign material contamination

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I

196 Inadequate optical transmission 168 Instructions not available
143 Inadequate quality assurance/control 144 Insulation degradation/deterioration
102 Incompatible components    

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L

154 Labeling contains inadequate instructions for use/maintenance 159 Labeling is not available
157 Labeling contains incorrect instructions for use/maintenance 150 Labeling problems (unspecified)
151 Labeling difficult to read/see 145 Lubrication excessive
152 Labeling difficult to understand 146 Lubrication insufficient
153 Labeling does not provide necessary information 147 Lubrication, loss of
156 Labeling is incomplete 148 Lubrication, wrong SAE (specifications)
    149 Lubrication, wrong type used - oil vs grease

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M

170 Manufacturing 135 Material degradetion/deterioration, anticipated or expected
174 Manufacturing - materials 137 Material degradation/deterioration, unanticipated or unexpected
171 Manufacturing - packaging 136 Material problem - post production
172 Manufacturing - process 180 Mechanical problem (i.e. pump, motor, wiring, cable, battery, parts, friction, etc)
173 Manufacturing - quality control 175 Manufacturing - user interface

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N

710 Negative results of device testing 709 None

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O

707 Operating steps confusing 190 Out of specification
100 Other (code unspecified, describe in H10)    

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P

160 Package insert information inadequate/incorrect 163 Package mislabled
167 Package insert missing 131 Premature power source depletion
162 Package labeling inadequate/incorrect 132 Premature RRT indicator (recommended replacement time)

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Q

191 Quality assurance

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S

164 Service manual (use in conjuction with another labeling code) 195 Sterillization
192 Shelf life exceeded 193 Storage/shipment

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T

194 Telemetry failure 176 Tolerance stack-up (hardware/software)
 
 

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U

165 User instruction manual (use in conjuction with another labeling code) 701 User/devices interface

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Use of Device


C

201 Cleaning error

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D

213 Device used according to labeled indications 215 Device used with incompatible equipment
214 Device used in appropriate environment 203 Device used with incompatible medium/material
202 Device used with inappropriate material 204 Disinfection error
708 Device performed according to specifications 702 Display hard to read or misleading

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E

120 Electrical problem (unspecified) 198 Electro-static interference
122 Electrical problem - open circuit 133 End of life - expected
123 Electrical problem - operating outside specifications 134 End of life - premature
121 Electrical problem - short circuit 138 Exceeded expected life of device
197 Electro-magnetic interference problem 140 Expeted wear/deterioration

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F

205 Failure to follow instructions 207 Failure to service/maintain according to manufacturer recommendations
206 Failure to remove packaging per use instructions 142 Foreign material contamination
141 Failure to cycle

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I

208 Incorrect technique/procedure 102 Incompatible components
196 Inadequate optical transmission 168 Instructions not available
143 Inadequate quality assurance/control 144 Insulation degradation/deterioration

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L

154 Labeling contains inadequate instructions for use/maintenance 159 Labeling is not available
157 Labeling contains incorrect instructions or use/maintenance 150 Labeling problem (unspecified)
151 Labeling difficult to read/see 145 Lubrication excessive
152 Labeling difficult to understand/see 146 Lubrication insufficient
153 Labeling does not provide necessary information 147 Lubrication, loss of
156 Labeling is incomplete 148 Lubrication,wrong SAE (specifications)
    149 Lubrication, wrong type used - oil vs grease

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M

170 Manufacturing 209 Misapplication/misuse of device
174 Manufacturing - materials 223 Modification of device - by authorized service organization
171 Manufacturing - packaging 225 Modification of devices - by distributor
172 Manufacturing - process 224 Modification of devices - by other service organization
173 Manufacturing - quality control 221 Modification of devices - by use/user facility biomedical engineering department
175 Manufacturing - user interface 236 Modification of devices - unspecified
135 Materials degradation/deterioration, anticipated or expected    
137 Materials degradation/deterioration, unanticipated of unexpected    
136 Material problem - post production    
180 Mechanical problem (i.e. pump, motor, wiring, cable, battery, parts, friction, ect.)    

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N

236 Negative results of device testing 710 Negative results of device testing
235 None 709 None

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O

200 Other (code unspecified, describe in H10) 100 Other (code unspecified, describe in H10)
707 Operating steps confusing 190 Out of specification

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P

160 Package insert information inadequate/incorrect 163 Package mislabled
167 Package insert missing 131 Premature power source depletion
162 Package labeling inadequate/incorrect 132 Premature RRT indicator (recommended replacement time)

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Q

191 Quality assurance

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R

230 Reuse of device - unspecified 231 Reuse of disposable device
232 Reuse of device beyond labeled specifications 233 Reuse of single use device
234 Reuse of device without following disinfection/sterilization instructions

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S

164 Services manual (use in conjuction with another labeling code) 195 Sterilization
192 Shelf life exceeded 193 Storage/shipment

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T

194 Telemetry failure 211 Timing error
176 Tolerence stack-up (hardware/software)

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U

165 User instruction manual (use in conjuction with another labeling code) 701 User/device interface
    212 Unapproved use of device

Physiological/Procedural Factors

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A

311 Anticipated adverse reaction - long term 310 Anticipated or known (physiological procedural related, but code unspecified)
312 Anticipated adverse reaction - short term    

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C

321 Caused by another drug/device 324 Caused by metal - microwave
323 Caused by magnetic fluid - MRI 325 Caused by operational context

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E

331 Environmental factors

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H

332 High/low temperature or humidity

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I

313 inherent risk of procedure

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K

314 Known long term complication of procedure 315 Known short term complication of procedure

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N

346 Negative results of device testing 345 None

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N

346 Negative results of device testing 345 None

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O

300 Other (code unspecified, describe in H10)

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P

333 Patient diagnosis contraindicated use of device 317 Patient's condition affected effectiveness of device
316 Patient's condition - predisposed event 318 Patient's condition contraindicated use of device

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R

322 Related to another drug/device 326 Related to operational context

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S

334 Support system problem (e.g.,facility oxygen flow system, electrical Failure of entire facility)

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U

340 Unanticipated (physiological/procedural related, but code unspecified) 343 Unanticipated long term complication of procedure
341 Unanticipated adverse reaction - long term 344 Unanticipated short term complication of procedure
342 Unanticipated adverse reaction - short term

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Page Last Updated: 06/19/2015
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