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U.S. Department of Health and Human Services

Medical Devices

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

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Component/Subassembly Failures

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

A

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

(To top of table)

B

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

(To top of table)

C

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

(To top of table)

D

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

(To top of table)

E

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

(To top of table)

F

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

(To top of table)

G

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

(To top of table)

H

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

(To top of table)

I

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

(To top of table)

J

   
853 Jack
854 Joint
855 Joystick
 
856 Jumper
857 Junction
   

(To top of table)

K

   
475 Keyboard
858 Keyer
859 Keypad
 
860 Kit
861 Knob

(To top of table)

L

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

(To top of table)

M

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

(To top of table)

N

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

(To top of table)

O

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

(To top of table)

P

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

(To top of table)

R

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

(To top of table)

S

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

(To top of table)

T

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

(To top of table)

U

   
444 User interface
   

(To top of table)

V

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

(To top of table)

W

 

 

 
1019 Washer
1020 Waveguide
1021 Window
 
430 Wire
544 Wiring harness

(To top of table)

Y

   
545 Y-piece connector
 
1022 Yoke

 To top of page

Computer-, Imaging System-, Microprocessor-Controlled Device Problems

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

A

   
617 Algorithm analysis
 
618 Algorithm problem

(To top of table)

B

   
657 Bus conflicts
 
633 Bus corruption

(To top of table)

C

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

(To top of table)

D

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

(To top of table)

E

   
664 Electromagnetic interference
 
648 Electrostatic discharge

(To top of table)

G

   
630 Glitch
   

(To top of table)

H

   
642 Heat
 
645 Humidity

(To top of table)

I

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

(To top of table)

K

   
 
621 Kernel
   

(To top of table)

L

   
638 Latch-up
 
644 Liquid ingress

(To top of table)

M

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

(To top of table)

N

   
665 None
   

(To top of table)

O

   
600 Other (code unspecified, describe in H10)
   

(To top of table)

P

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

(To top of table)

R

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

(To top of table)

S

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

(To top of table)

T

   
651 Temperature fluctuation
634 Timing violation
 
620 Token
632 Transmission effects

(To top of table)

U

   
613 User installation error
 
614 User maintenance error

(To top of table)

V

   
624 Vector processing
 
649 Vibration

(To top of table)

W

   
623 Watchdog
   

 To top of page

RESULTS OF EVALUATION CODES
(ordered alphabetically within each category)

DEVICE

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

A

   
703 Alarms inadequate or absent
   

(To top of table)

C

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

(To top of table)

D

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

(To top of table)

E

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

(To top of table)

F

   
141 Failure to cycle
 
142 Foreign material contamination

(To top of table)

I

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

(To top of table)

L

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

(To top of table)

M

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

(To top of table)

N

   
710 Negative results of device testing
 
709 None

(To top of table

O

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

(To top of table)

P

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

(To top of table)

Q

   
191 Quality assurance
   

(To top of table)

S

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

(To top of table)

T

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

(To top of table)

U

   
165 User instruction manual (use in conjunction with another labeling code)
 
701 User/device interface

 Top of page

USE OF DEVICE

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

C

   
201 Cleaning error
   

(Top of table)

D

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

(Top of table)

E

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

(Top of table)

F

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

(Top of table)

I

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

(Top of table)

L

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

(Top of table)

M

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

(Top of table)

N

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

(Top of table)

O

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

(Top of table)

P

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

(Top of table)

Q

   
191 Quality assurance
   

(Top of table)

R

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

(Top of table)

S

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

(Top of table)

T

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

(Top of table)

U

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

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PHYSIOLOGICAL / PROCEDURAL FACTORS

A B C D E F G H I J K L M N O P Q R S T U V W X Y

A

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

(To top of table)

C

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

(To top of table)

E

   
331 Environmental factors
   

(To top of table)

H

   
332 High/low temperature or humidity
   

(To top of table)

I

   
313 Inherent risk of procedure
   

(To top of table)

K

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

(To top of table)

N

   
346 Negative results of device testing
 
345 None

(To top of table)

O

   
300 Other (code unspecified, describe in H10)
   

(To top of table)

P

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

(To top of table)

R

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

(To top of table)

S

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

(To top of table)

U

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

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