Source Subset Code Subset Name Concept Code Source PT Source Definition Source Synonym(s) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50372 Absorber FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49804 Absorber (CO2) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49806 Accumulator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49807 Actuator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49808 Adapter (Adaptor) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49810 Air cleaner FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50339 Air Eliminator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49811 Air pump assembly FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49813 Alarm FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49812 Alarm, assembly FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49814 Alarm, audible FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49817 Alarm, high inspiratory pressure FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49815 Alarm, LED FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49819 Alarm, low inspiratory pressure FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49818 Alarm, oxygen pressure FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49820 Alarm, power FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49816 Alarm, pressure FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49821 Alarm, self FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49822 Alarm, visual FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49823 Alarm, volume FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49824 Alternator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50057 Altimeter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49825 Amplifier FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49826 Analyzer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49827 Annunciator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49828 Antenna FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50341 Applicator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49829 Arrester FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49830 Attenuator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50317 Automatic Injection System FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49831 Backpanel FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49832 Backplane FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49958 Bacterial filter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49833 Baffle FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49834 Bags FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49835 Ball FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49836 Ballast FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49837 Balloon FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49838 Barrier FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49839 Battery FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50346 Battery Charger FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49841 Beam splitter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49842 Bearings FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C51066 Bed, Assist Bar FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49843 Bell FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49844 Belt FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49845 Blower FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49846 Bobbin FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50056 Bolometer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49847 Bolt FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50289 Bolus mechanism FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49848 Bottom dead center sensor bracket FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49849 Brake FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49850 Breathing circuit FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49851 Brush FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50354 Bubble Detector FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49852 Bus FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49853 Bushing FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49854 Buzzer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49855 Cable FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49857 Calibrator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49858 Camera FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50343 Cannula FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50274 Cannula Guide FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49859 Cannula, inner FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49860 Cannula, outer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49861 Cap FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49862 Capacitor (ceramic chip) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49863 Carrier FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49864 Cascade FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49865 Cassette FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49866 Caster FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50344 Catheter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50345 Cautery FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49867 Cell FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49868 Charger FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49869 Chassis FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49870 Choke FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49871 Circuit board FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50347 Circuit Breaker FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49872 Clamp FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49873 Clip FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49874 Clock FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C53997 CO2 monitor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49875 CO2 monitor subassembly (only use when part of another device) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49876 Coder FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49877 Coil FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49881 Collimator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49882 Comparator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50129 Compressor (air pump) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C61402 Computer Hardware FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C61403 Concentrate FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49883 Concentrator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49878 Conductor coil FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49884 Connecting rod FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49885 Connector FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50295 Connector Pin FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50031 Contact lens FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50204 Control switches FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49887 Controller FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49888 Converter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50319 Cooling module Cooling System FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49890 Cord FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49893 Core FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49894 Counter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50352 Counterbalance FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49895 Coupler FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49896 Cover FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50332 CPU (central processing unit of computer system) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49897 CPU (central processing unit) board FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49898 Crank arm assembly FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50238 CRT (cathode ray tube) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49899 Crystal FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49900 Cuff FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50165 Cup seal FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49901 Cups FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49902 Current limiter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49903 Current source FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49904 Cusp FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49905 Cutter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50342 Cutter-Torque Cable FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49906 Cylinder FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50259 Cylinder valve FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49907 Damper FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50241 Data acquisition unit FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49908 Decoder FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49909 Defibrillator paddles FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49910 Defibrillator subassembly (only use when part of another device) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49911 Dehumidifier FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49912 Dehydrator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50353 Deionizer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49913 Delay line FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49914 Demagnetizer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49915 Demodulator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50055 Densitometer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49916 Detector FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49755 Device Component or Accessory FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49918 Device deployer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C68676 Device Ingredient or Reagent FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49919 Dial FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49920 Diaphragm FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49921 Digitizer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49922 Diode FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49924 Discrete component/device (resistor, capacitor, diode) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49925 Disk FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49927 Display FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49928 Divider FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49929 Dome FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49930 Doubler FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49931 Driver FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49932 Duct FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49933 Dummy load FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49934 Duplexer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50075 EKG/ECG monitor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49935 EKG/ECG subassembly (only use when part of another device) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50027 Electrical lead FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50336 Electrical Wire FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49936 Electrode FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50351 Electrode Contact FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50308 Emergency Stop Button or Switch FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50309 Emergency Table Stop FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49937 Emitter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49938 Enclosure FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49939 Encoder FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49940 Endoscope FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50338 Endoscopic Accessory FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50049 EPROM (erasable programmable read only memory) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49941 Equalizer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49942 Evaporator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49957 Exhalation filter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49943 Expander FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49944 Extender FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50359 External Fiberoptic FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49945 Extractor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49946 Eyelet FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50208 Fail-safe system FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49947 Fan FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49948 Fastener FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49949 Feedthru FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49950 Ferrule FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49951 FET (field effect transistor) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49952 Fiber FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50362 Fiberguide FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50358 Fiberoptic FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50348 Fiberoptic Cladding FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50349 Fiberoptic Cleaver FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49955 Film FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C69444 Film Processor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49956 Filter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49959 Flange FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49960 Flasher FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50054 Flowmeter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49961 Foil FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49962 Foot pedal FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50202 Foot switch FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49963 Frame FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50002 Function indicator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50284 Function Indicator Light FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49964 Function lid FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49965 Furnace FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49966 Fuse FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50314 Gas delivery system FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49967 Gas scavenging FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49968 Gasket FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50052 Gauges/meters Meter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49969 Gears Gear FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49970 Generator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49971 Grille FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49972 Grommet FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49973 Ground strap FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49974 Guide FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50271 Guidewire FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50281 Hand immobilizer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50275 Handpiece FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50276 Handrest FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49977 Handset FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50277 Haptic FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49978 Header FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49979 Headphone FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49980 Heads FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49982 Headset FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49983 Heart valve cage FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50029 Heart valve leaflet FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50150 Heart valve sewing ring FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49984 Heat exchanger FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49985 Heat sink FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49986 Heater FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49987 Heater rod FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49880 Helifix coil FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50335 Hemo Valve FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50302 Hermetic Seal FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49988 Hinge FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49989 Holder FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49953 Hollow fiber FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50279 Hose FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50280 Hose Line FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49990 Housing FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49991 Hub FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49992 Humidifier FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49993 Hybrid circuit FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50313 Hydraulic Bed System FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50312 Hydraulic System FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49994 IC (integrated circuit) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49995 IC (integrated circuit) chip FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49996 Igniter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49997 Imager FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49998 Impedance converter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50000 Indexer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50001 Indicator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50003 Inductor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50316 Injection System Injector system FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50004 Insulation FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50005 Integrator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50006 Intercom FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50007 Interconnection board intubate FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50008 Interface FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50009 Interrupter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50298 Intravenous Pole FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50010 Inverter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49999 IOL (intraocular lens) implant FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50011 Isolator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50012 Jack FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C54020 Jaw FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50013 Joint FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50015 Joystick FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50016 Jumper FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50017 Junction FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50018 Keyboard FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50019 Keyer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50020 Keypad FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50021 Kit FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C54021 Knife FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50022 Knob FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50023 Label FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50024 Laminate FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50025 Lamp FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50026 Laser FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50292 Laser nozzle FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C54022 Latch FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50282 Lead FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50028 Lead conductor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50326 Lead Tip FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50283 Leaflet FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50357 Leaflet Disk FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49923 LED (light emitting diode) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50030 Lenses FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50201 Limit switch FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50032 Limiter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50033 Line conditioner FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49840 Lithium iodide battery FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50034 Load FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50035 Lock FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50286 Locking mechanism FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50036 Locking sleeve FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50287 Lockout Mechanism FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50037 Logic board FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50038 Lower piston bearing FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50260 Luer valve FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50039 Magazine FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50040 Magnet FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50041 Magnetizer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50053 Magnetometer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50042 Magnetoresistor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50043 Magnifier FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50044 Manifold FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50045 Matrices FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50285 Mechanism FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50046 Membrane FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50047 Memory FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50082 Meter needle FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50067 Microcircuit FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50068 Microphone FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50069 Microscope FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50070 Mirror FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50071 Mixer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50072 Modem FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50073 Modulator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50074 Monitor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50076 Mother board FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50355 Motion Detector FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50077 Motor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50331 Motor Drive Unit FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50103 Motor roll pin FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50079 Mount FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C54010 Multiplier FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50080 Nebulizer (only use when part of another device) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50290 Needle FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50081 Network FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50083 None FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50291 Nozzle FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50325 Nozzle Tip FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50084 Nuts FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50085 O2 monitor subassembly (only use when part of another device) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50168 O2 sensor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50086 Obturator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50334 One-Way Valve FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49856 Optical cable FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49926 Optical disk FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49954 Optical fiber FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50087 Optocoupler FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50088 Oscillator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50089 Oscilloscope FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50091 Outlet FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50092 Oven FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50093 Overlay FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50065 Oximeter (only use when part of another device) Oximeter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50094 Oxygen analyzer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50095 Pad FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50293 Pallet FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50096 Panel FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50097 PC (printed circuit) board FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49917 Photodetector FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50098 Photomultiplier FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50328 Photomultiplier (PM) Tube FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50099 Phototransistor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50100 Pickup FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50261 Pilot balloon valve FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50101 Pin FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50296 Pipette FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49975 Piston guides FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49981 Piston heads FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50104 Piston Pads FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50105 Pivot FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50106 Plate FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50107 Plotter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50108 Plug FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50297 Plunger FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50109 Pointer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50110 Polarizer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50111 Port FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50112 Post FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50064 Potentiometer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49892 Power cord FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50113 Power lamp FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50114 Power module FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50115 Power supply FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50200 Power switch FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50116 Preamplifier FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50117 Prescaler FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50118 Preselector FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50167 Pressure sensor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50119 Pressure signal FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50239 Pressure tubing FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50120 Printer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50121 Probe FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50299 Probe, Transducer Pressure FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50122 Processor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50123 Programmer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50050 PROM (programmable read only memory) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50124 Prong FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50125 Protector FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50203 Proximity switch FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50126 Pulley FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50127 Pulser FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50128 Pump FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C54023 Pusher FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50063 Pyrometer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50130 Rail FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50051 RAM (random access memory) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50303 Rate modulated pacing sensor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50131 Reactor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50132 Reader FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50133 Receiver FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50330 Receiver Stimulator Unit FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50134 Recorder (tape, stripchart, etc.) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50135 Rectifier FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50136 Reed (electrically open) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50137 Regulator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50138 Relay FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50139 Repeater FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50140 Reservoir FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50141 Resistor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50143 Resonator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50144 Retainer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50102 Retaining pin FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50145 Reticle FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50146 Rheostat FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50147 Ribbon FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50148 Ring FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50151 Rivet FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50152 Robot FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50153 Rod FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50048 ROM (read only memory) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50154 Safety interlock FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50155 SAW (surface acoustic wave device) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50156 Scale FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50157 Scaler FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50158 Scanner FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50062 Scintillometer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50159 Scrambler FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50160 Screen FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50161 Screw FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50278 Screw Head FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50321 Screw Tapper FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50162 Scriber FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50163 Seal FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50164 Seal tracheal FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50360 Sediment Filter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50166 Sensor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50169 Servo FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50170 Shaft FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50171 Shield FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50172 Shift register FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50173 Shifter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50305 Shoulder Support FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50174 Shunt FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50175 Shutter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50301 Side Rail FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50176 Signal conditioner FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50177 Simulator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50178 Slide FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50149 Slip ring FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50179 Slotter line FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50180 Socket FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49809 Socket adaptor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50014 Solder joint FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50181 Solenoid FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49805 Sound absorber FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50182 Spacer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50183 Spark gap FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50184 Speaker FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50061 Spectrometer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50306 Speech Processor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50066 Spirometer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50185 Splicer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50186 Spooler FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50187 Spring FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50288 Spring Loading Mechanism FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50188 Stabilizer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50189 Stand FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50307 Staple FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50337 Steering Wire FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50190 Stent FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50078 Stepper motor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50191 Stiffener FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50192 Stopcock FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50333 Stopcock Valve FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50193 Strain relief FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50194 Strip line FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50195 Stylet FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50196 Substrate FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50197 Sunlamp FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50198 Suppressor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50364 Surgical Graft FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50365 Suture FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C54013 Switch, push button FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50199 Switches FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50205 Synchronizer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50206 Synthesizer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50207 Syringe FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50310 Syringe Drive FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50311 System FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50371 Table FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50320 Table Top FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50060 Tachometer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50209 Tape FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50210 Tee FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50211 Telemetry equipment FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50212 Telephone FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50213 Teleprinter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50214 Teletypewriter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50242 Television unit FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50215 Temperature compensator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50300 Temperature Probe FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50304 Temperature sensor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50216 Terminal FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50217 Terminal assembly FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50218 Terminator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50322 Test Strip FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50219 Thermistor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50220 Thermocouple FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50270 Thermocouple wire FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50059 Thermometer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50221 Thermostat FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50323 Thread FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50222 Thyristor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50223 Timer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50324 Tip FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49879 Tip conductor coil FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50294 Tomographic Pallet FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50350 T-piece connector FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50224 Trackball FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50225 Transceiver FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50226 Transducer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50227 Transformer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50228 Transistor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50229 Translator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50230 Transmission line FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50231 Transmitter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50232 Transponder FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50233 Transport FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50234 TRIAC Three Terminal Current Controlling Semiconductor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50235 Trimmer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50327 Trocar FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50236 Tube FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50237 Tube capillary FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50240 Tuner FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C54008 User interface FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50243 Valve Valve (one-way, hemo, stopcock, etc.) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C54016 Valve cam FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50244 Valve, control FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50245 Valve, directional FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50246 Valve, dump FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50247 Valve, exhalation FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50248 Valve, flap FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50249 Valve, flow FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50250 Valve, inhalation FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50251 Valve, inlet port FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50252 Valve, inspiratory FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50253 Valve, outlet port FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50254 Valve, PEEP (positive end expiratory pressure) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50255 Valve, pressure limit FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50256 Valve, relief FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50257 Valve, safety FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50258 Valve, selector FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50262 Vaporizer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50263 Varistor FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50264 VDT (video display terminal) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50265 Vibrator FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50266 Viewer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50058 Voltmeter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50267 Washer FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50315 Water Purification System FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49976 Waveguide FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50361 Wedge Filter FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C51067 Wheel FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C51069 Wheelchair, Tires FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C51068 Wheelchair, Wheels FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50268 Window FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50269 Wire FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50272 Wiring harness FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50273 Yoke FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49886 Y-piece connector FDA C54451 Medical Device Problem Codes FDA CDRH C63281 Aborted charge Issue associated with the spontaneous ending of the charging process in relation to the apparent surface voltage present on an electrostatic recording medium. Charge, aborted FDA C54451 Medical Device Problem Codes FDA CDRH C63036 Accessory incompatible Accessories, incompatible FDA C54451 Medical Device Problem Codes FDA CDRH C63312 Accidental spillage Issue associated with the unexpected flowing or pouring of liquids, gas or air substances into the environments or conditions in which the device is being used. Spillage, accidental FDA C54451 Medical Device Problem Codes FDA CDRH C63034 Advancement issue Issue associated with the forward movement of the device and/or device components to an intended location. FDA C54451 Medical Device Problem Codes FDA CDRH C63311 Air leak Air leak(s) FDA C54451 Medical Device Problem Codes FDA CDRH C63309 Alarm not visible FDA C54451 Medical Device Problem Codes FDA CDRH C63308 Ambient noise issue Issue associated with any undesired signal (electric or acoustic) from the environment that tends to interfere with the reception, interpretation, or processing of a signal pertinent to the device. FDA C54451 Medical Device Problem Codes FDA CDRH C63307 Ambient temperature tissue Issue associated with the thermal state in the immediate environment in which a device is being used. FDA C54451 Medical Device Problem Codes FDA CDRH C63306 Application interface becomes non-functional or program exits abnormally Crash or lock-up FDA C54451 Medical Device Problem Codes FDA CDRH C64349 Application network issue 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. FDA C54451 Medical Device Problem Codes FDA CDRH C63032 Application problems Issue associated with difficulties in attaching a device to another object including another device or device component or to a patient body part. FDA C54451 Medical Device Problem Codes FDA CDRH C63305 Application program issue Issue associated with the requirement for software to fulfill its function within an intended use or application. FDA C54451 Medical Device Problem Codes FDA CDRH C63304 Application program version or upgrade problem FDA C54451 Medical Device Problem Codes FDA CDRH C63042 Application security issue 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. Computer virus infection FDA C54451 Medical Device Problem Codes FDA CDRH C63301 Arcing Issue associated with arc strikes characterized by localized burn damage to a part from an arc caused by making or breaking an energized electrical circuit. FDA C54451 Medical Device Problem Codes FDA CDRH C63303 Arcing at electrodes FDA C54451 Medical Device Problem Codes FDA CDRH C63302 Arcing at paddles FDA C54451 Medical Device Problem Codes FDA CDRH C63300 Artifact Issue associated when an extrinsic agent, method or image produces any item (display, suspension etc) that is not naturally present. FDA C54451 Medical Device Problem Codes FDA CDRH C63299 Aspiration issue FDA C54451 Medical Device Problem Codes FDA CDRH C63297 Bacterial contamination of device Contamination, bacterial|Bacterial contamination FDA C54451 Medical Device Problem Codes FDA CDRH C64334 Battery impedance issue FDA C54451 Medical Device Problem Codes FDA CDRH C63030 Battery issue FDA C54451 Medical Device Problem Codes FDA CDRH C63296 Bent Issue associated with the change in angle of a material as a function of steadily applied forces. Bent Material|Bend material FDA C54451 Medical Device Problem Codes FDA CDRH C63294 Biocompatibility issue FDA C54451 Medical Device Problem Codes FDA CDRH C63293 Biofilm coating in device Biofilm coating FDA C54451 Medical Device Problem Codes FDA CDRH C63292 Biological environmental factor FDA C54451 Medical Device Problem Codes FDA CDRH C63290 Bleed back FDA C54451 Medical Device Problem Codes FDA CDRH C63289 Blockage within device or device component Blockage FDA C54451 Medical Device Problem Codes FDA CDRH C63288 Blocked connection 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. FDA C54451 Medical Device Problem Codes FDA CDRH C62973 Break Issue associated with undesired damage or breakage of those materials used in device construction. Device breakage|Material break FDA C54451 Medical Device Problem Codes FDA CDRH C63287 Buckled material Issue associated with an undesired bulge, bend, bow, kink, or wavy condition observed in the device material resulting from compressive stresses. FDA C54451 Medical Device Problem Codes FDA CDRH C63286 Burn of device or device component Issues associated with a discoloration or destruction as a result of thermal decomposition of the material used for the device construction. (Adapted from 10th ed. ASTM Dictionary of Engineering Science and Technology D3918, D20 page 77.) Burn|Burnt|Burned FDA C54451 Medical Device Problem Codes FDA CDRH C62972 Burst Issue associated with an undesired open breakage in the materials that are used in device construction. Material burst FDA C54451 Medical Device Problem Codes FDA CDRH C63285 Calcified Issue associated with the gradual decrease in the efficiency of the device comprising material(s) impregnated with calcium salts and deposition of calcareous material. Calcification|Calcified material FDA C54451 Medical Device Problem Codes FDA CDRH C63284 Calibration error Miscalibration FDA C54451 Medical Device Problem Codes FDA CDRH C63028 Calibration issue Issue associated with the comparison of a measurement system or device of unverified accuracy to a measurement system or device of unknown and greater accuracy, to detect and correct any variation from required performance specifications of the measurement of the system or device. FDA C54451 Medical Device Problem Codes FDA CDRH C63283 Capacitive coupling FDA C54451 Medical Device Problem Codes FDA CDRH C63027 Capturing issue 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. FDA C54451 Medical Device Problem Codes FDA CDRH C63282 Changes in ambient temperature in device environment Ambient temperature, changes in FDA C54451 Medical Device Problem Codes FDA CDRH C63026 Charging issue Issue associated with the inability of device and/or device components to successfully charge an electrical source. FDA C54451 Medical Device Problem Codes FDA CDRH C63279 Charred FDA C54451 Medical Device Problem Codes FDA CDRH C62945 Chemical issue Issue associated with any deviations from device documented performance specifications relating to any chemical characterization, i.e., element, compound, or mixture. FDA C54451 Medical Device Problem Codes FDA CDRH C63278 Chemical spillage Issue associated with unintentional pouring out or releasing of chemical substances. FDA C54451 Medical Device Problem Codes FDA CDRH C63277 Circuit Failure Issue associated with the electrical network paths on a physical medium, e.g. a circuit board where the signals fail to be conducted across two or more connected points. FDA C54451 Medical Device Problem Codes FDA CDRH C63276 Cleaning disinfecting or sterilization problem during device use 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. FDA C54451 Medical Device Problem Codes FDA CDRH C63275 Clumping in device or device ingredient Issue associated with the aggregation of particles, such as bacteria, into irregular masses. Clumping FDA C54451 Medical Device Problem Codes FDA CDRH C63274 Coagulation in device or device ingredient Issue associated with the undesired characterization of congealing, solidifying, thickening, curdling. Coagulation FDA C54451 Medical Device Problem Codes FDA CDRH C63273 Coiled FDA C54451 Medical Device Problem Codes FDA CDRH C63272 Collapse Issue associated with the buckling or crushing of material from external forces. FDA C54451 Medical Device Problem Codes FDA CDRH C63271 Communication or transmission issue Issue associated with any deviations from device documented performance specifications relating to the signal structures and information exchanges between integrated circuits and terminal interfaces both intra and interoperationally. FDA C54451 Medical Device Problem Codes FDA CDRH C63153 Component falling 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. Component(s) falling FDA C54451 Medical Device Problem Codes FDA CDRH C63022 Component incompatible Component(s), incompatible FDA C54451 Medical Device Problem Codes FDA CDRH C63021 Component missing 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. Components, missing FDA C54451 Medical Device Problem Codes FDA CDRH C63020 Component or accessory incompatibility 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. FDA C54451 Medical Device Problem Codes FDA CDRH C63270 Computer operating system issue 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. FDA C54451 Medical Device Problem Codes FDA CDRH C63269 Computer software issue Issue associated with any deviations from device documented performance specifications relating to written programs, codes, and/or software system that provide a capability to satisfy a stated need or objective which combines with one or more of the following: installation, software components, process, hardware, facilities and people. Computer software error FDA C54451 Medical Device Problem Codes FDA CDRH C64348 Computer system security issue FDA C54451 Medical Device Problem Codes FDA CDRH C63267 Confusing instruction for device use 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. FDA C54451 Medical Device Problem Codes FDA CDRH C62952 Connection issue Issue associated with linking of device and/or device components and/or the functional units set up to provide means for a transfer of fluid, gas, or data. FDA C54451 Medical Device Problem Codes FDA CDRH C63018 Contamination during use Issue associated with the undesired introduction of impurities either chemical or microbiological in nature, or of foreign matter into or onto the raw material or during production, sampling, packaging or repackaging, during transport or during use of the device. Contamination FDA C54451 Medical Device Problem Codes FDA CDRH C63265 Continuous firing Issue associated with the excessive production of electrical impulses over a period. FDA C54451 Medical Device Problem Codes FDA CDRH C63263 Corrosion 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. Corrode|Corroded FDA C54451 Medical Device Problem Codes FDA CDRH C62971 Crack 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. Material crack|Crack(s) FDA C54451 Medical Device Problem Codes FDA CDRH C63261 Cross reactivity Issue associated with the degree to which an antibody or antigen participates in cross reactions. FDA C54451 Medical Device Problem Codes FDA CDRH C63260 Cut in material Cut|Cut(s) FDA C54451 Medical Device Problem Codes FDA CDRH C63258 Data back-up problem 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. FDA C54451 Medical Device Problem Codes FDA CDRH C63257 Data corrupted FDA C54451 Medical Device Problem Codes FDA CDRH C67508 Date-related problem, not year 2000 (Y2K) Issue associated with programming of calendar dates and/or time as a factor in the operation of a medical device. FDA C54451 Medical Device Problem Codes FDA CDRH C63256 Decoupling Issue associated with the device and/or device components being un-associated in such a way that fluid, gas, power or signal information may not be transferred from one to another. FDA C54451 Medical Device Problem Codes FDA CDRH C63255 Decrease in pressure Pressure, decrease in FDA C54451 Medical Device Problem Codes FDA CDRH C63254 Decrease in suction Issue associated with the removal by suction of excess fluid or gas from a body cavity. Aspiration, incomplete|Incomplete aspiration|Suction, decrease in FDA C54451 Medical Device Problem Codes FDA CDRH C63252 Decreased pump speed Pump speed, decreased FDA C54451 Medical Device Problem Codes FDA CDRH C63253 Decreased sensitivity Sensitivity, decreased FDA C54451 Medical Device Problem Codes FDA CDRH C63251 Defective Alarm Alarm, defective FDA C54451 Medical Device Problem Codes FDA CDRH C63023 Defective component Issue associated with a device component having flaws of dimensional deviations greater than acceptable for the intended use. Components, defective FDA C54451 Medical Device Problem Codes FDA CDRH C63250 Defective item Issue associated with having flaws or dimensional deviations greater than acceptable for the intended use of the device. Device, defective FDA C54451 Medical Device Problem Codes FDA CDRH C63249 Deflation issue Issue associated with the inability of device and/or device components to release gas or air. Deflation difficulties FDA C54451 Medical Device Problem Codes FDA CDRH C62970 Degraded Issue associated with a deleterious change in the chemical structure, physical properties, or appearance in the materials that are used in device construction. Material degradation FDA C54451 Medical Device Problem Codes FDA CDRH C63247 Delayed alarm Alarm, delayed FDA C54451 Medical Device Problem Codes FDA CDRH C63280 Delayed charge time Charge times, delayed FDA C54451 Medical Device Problem Codes FDA CDRH C63014 Delivered as unsterile product Issue associated with the delivery of a device and/or device component that has any viable organism, either active or dormant, thereby compromising the device's sterility. Nonsterility FDA C54451 Medical Device Problem Codes FDA CDRH C63246 Delivery system failure FDA C54451 Medical Device Problem Codes FDA CDRH C63245 Dent in material Dent FDA C54451 Medical Device Problem Codes FDA CDRH C63013 Deployment issue Issue associated with any deviations from device documented performance specifications relating to the sequence of events for activation and positioning of a module to a specific location, e.g. for interventional stenting, optimal deployment can be defined as the stent being fully opened along the length of the stent and embedded in the arterial tissue or pathology. FDA C54451 Medical Device Problem Codes FDA CDRH C63243 Detachment of device component Component(s), detachment of|Device component detached FDA C54451 Medical Device Problem Codes FDA CDRH C63242 Detachment of device or device component Issue associated with the separation of the device and/or device components from its physical construct, integrity, or chassis. Device or device component detached FDA C54451 Medical Device Problem Codes FDA CDRH C63037 Device abrasion from instrument or another object Abrasion from instrument/object FDA C54451 Medical Device Problem Codes FDA CDRH C63033 Device alarm system issue 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. Alarm, failure to|Alarm failure FDA C54451 Medical Device Problem Codes FDA CDRH C63024 Device clogged Clogged FDA C54451 Medical Device Problem Codes FDA CDRH C63017 Device Contamination with biological material FDA C54451 Medical Device Problem Codes FDA CDRH C63016 Device contamination with blood or blood product Blood contaminated device FDA C54451 Medical Device Problem Codes FDA CDRH C63015 Device damaged prior to use Damage, internal/external|Item damaged prior to use|Damaged item FDA C54451 Medical Device Problem Codes FDA CDRH C63010 Device difficult to prepare 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. Prep, difficult to FDA C54451 Medical Device Problem Codes FDA CDRH C63008 Device disinfection or sterilization issue FDA C54451 Medical Device Problem Codes FDA CDRH C63004 Device emits odor FDA C54451 Medical Device Problem Codes FDA CDRH C62998 Device expiration issue Issue associated with the use beyond the expected maximum period of useful life as defined by the manufacturers. Expiration date exceeded FDA C54451 Medical Device Problem Codes FDA CDRH C62984 Device flammable Flammable FDA C54451 Medical Device Problem Codes FDA CDRH C62982 Device ingredient or reagent issue FDA C54451 Medical Device Problem Codes FDA CDRH C62979 Device inoperable 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, inoperable FDA C54451 Medical Device Problem Codes FDA CDRH C62996 Device Issue Malfunction|Device failure FDA C54451 Medical Device Problem Codes FDA CDRH C62977 Device maintenance issue Issue associated with deficient device servicing. Maintain, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C62975 Device marking unclear Issue associated with the clarity of any 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. FDA C54451 Medical Device Problem Codes FDA CDRH C62976 Device markings issue FDA C54451 Medical Device Problem Codes FDA CDRH C62974 Device markings worn out Issue associated with the aging or wear of any 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. FDA C54451 Medical Device Problem Codes FDA CDRH C62957 Device misassembled during manufacturing or shipping FDA C54451 Medical Device Problem Codes FDA CDRH C62955 Device operates differently than expected Issue associated with any deviations from documented performance specifications relating to device use in terms of unmet user needs or expectations while operating and using the device. FDA C54451 Medical Device Problem Codes FDA CDRH C62954 Device operational issue Issue associated with any deviations from specifications relating to device operations in terms of, deployment, connection, electrical, computer software, infusion/flow, output, protective-measure, and incompatibility issues. FDA C54451 Medical Device Problem Codes FDA CDRH C62951 Device or device component damaged by another device Issue associated with the mechanical action of one material scratching and grinding another material between two or more devices. FDA C54451 Medical Device Problem Codes FDA CDRH C64341 Device or device component incrementation issue FDA C54451 Medical Device Problem Codes FDA CDRH C63038 Device or device fragments location unknown Device/device fragments, unknown location of FDA C54451 Medical Device Problem Codes FDA CDRH C62946 Device or device fragments remain in patient Issue associated with the inability to retrieve device and/or device fragments during medical procedures. FDA C54451 Medical Device Problem Codes FDA CDRH C63240 Device packaging compromised Issue associated with the non-conformance to device specifications and minimum packaging requirements as the device may not be operating and functioning as intended. FDA C54451 Medical Device Problem Codes FDA CDRH C62938 Device performance issue Issue associated with the published instructions and requirements set forth by the device manufacturers for the procedures, methods, and techniques to use the designed equipment or systems. Performance FDA C54451 Medical Device Problem Codes FDA CDRH C62931 Device remains activated Issue associated with the occurrence of a signal line making a transition from its inactivated state to its active state and remains in this state when it is not expected to. FDA C54451 Medical Device Problem Codes FDA CDRH C63238 Device sensing issue 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. FDA C54451 Medical Device Problem Codes FDA CDRH C62927 Device setting does not match patient condition Issue associated with deviations from device-device documented performance specifications relating to device use in terms of the mismatch between the device setting parameters and the patient anatomical and/or physiological characteristics. FDA C54451 Medical Device Problem Codes FDA CDRH C62924 Device stops intermittently Issue associated with any deviation from device document specification relating to the irregular rate at which the device stops. FDA C54451 Medical Device Problem Codes FDA CDRH C62920 Device unsafe to use in environment FDA C54451 Medical Device Problem Codes FDA CDRH C63236 Device-device incompatibility 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. FDA C54451 Medical Device Problem Codes FDA CDRH C63035 Difficult or delayed activation Activation, difficult /delayed|Activation, difficult or delayed FDA C54451 Medical Device Problem Codes FDA CDRH C63235 Difficult to advance Issue associated with the difficulty to see a forward movement of the device and/or device components to an intended location. FDA C54451 Medical Device Problem Codes FDA CDRH C63244 Difficult to deploy Issue associated with users experiencing difficulty or uneasiness to deploy device and/or device components to a specified location. Deploy, difficult to FDA C54451 Medical Device Problem Codes FDA CDRH C63317 Difficult to flush Flush, difficult to FDA C54451 Medical Device Problem Codes FDA CDRH C63234 Difficult to fold or unfold 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. Fold, difficult to FDA C54451 Medical Device Problem Codes FDA CDRH C63233 Difficult to insert Issue associated with the use of the device in terms of user experiencing difficulty to introduce or to intervene with a device and/or device components, even if the operation is being performed according to labeled instructions for use. Insertion difficulties FDA C54451 Medical Device Problem Codes FDA CDRH C63232 Difficult to interrogate Issue associated with difficulty of a transponder system to trigger a response. Interrogate, difficult to FDA C54451 Medical Device Problem Codes FDA CDRH C63012 Difficult to open or close 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. FDA C54451 Medical Device Problem Codes FDA CDRH C63231 Difficult to open or remove packaging material Issue associated with difficulty for end-users to operate device, specifically as it relates to the opening or removal of the outer wrapping. FDA C54451 Medical Device Problem Codes FDA CDRH C63230 Difficult to position 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. Positioning difficulties FDA C54451 Medical Device Problem Codes FDA CDRH C64339 Difficult to program Program, difficult to FDA C54451 Medical Device Problem Codes FDA CDRH C63228 Difficult to remove 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. Removal difficulties FDA C54451 Medical Device Problem Codes FDA CDRH C63009 Difficult to use or set up Issue associated with any deviations from device documented performance specifications relating to device use in terms of users experiencing difficulty in setting up, preparing and/or using the device. FDA C54451 Medical Device Problem Codes FDA CDRH C63226 Difficult to wedge Issue associated with the use of the device in terms of user experiencing difficulty to mold into a triangular cross-section of device and/or device components, even if the operation is being performed according to labeled instructions for use. Wedge, difficult to FDA C54451 Medical Device Problem Codes FDA CDRH C63225 Disassembly FDA C54451 Medical Device Problem Codes FDA CDRH C63223 Disconnection 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. Broken Connection|Disconnect FDA C54451 Medical Device Problem Codes FDA CDRH C62950 Dislodged or dislocated Issue associated with mechanical force that displaces device and/or device components from an intended location. Dislocated|Dislodged FDA C54451 Medical Device Problem Codes FDA CDRH C63221 Display misread Issue associated with not correctly reading the patient or test result information provided by the device. FDA C54451 Medical Device Problem Codes FDA CDRH C63220 Dose calculation error due to software problem Dose calculation error FDA C54451 Medical Device Problem Codes FDA CDRH C63219 Dull FDA C54451 Medical Device Problem Codes FDA CDRH C63007 Electrical issue Issue associated with any deviations from device documented performance specifications relating to electrical processes of a device and/or device components that have an applied part or transferred energy to and from the patient or detect such energy transfer to or from the patient. Device electrical issue|Electrical failure FDA C54451 Medical Device Problem Codes FDA CDRH C63218 Electrical overstress Issue associated with an electrical activity that exceeded the specified threshold limit of the internal integrated circuitry. FDA C54451 Medical Device Problem Codes FDA CDRH C63217 Electrical power problem Issue associated with the power supply or electrical energy, including batteries that provide power for the parent device or power to run auxiliary functions, e.g., alarms or memory. FDA C54451 Medical Device Problem Codes FDA CDRH C63006 Electrical resistance issue Issue associated with the occurrence at which the ratio of voltage applied to a current flowing in a body, i.e., resistance, neglects capacitative and inductive effects. FDA C54451 Medical Device Problem Codes FDA CDRH C63216 Electrical shorting FDA C54451 Medical Device Problem Codes FDA CDRH C63215 Electromagnetic compatibility issue Issue associated with the ability of a system to function in its electromagnetic environment without introducing intolerable disturbances to anything in its environment. FDA C54451 Medical Device Problem Codes FDA CDRH C63214 Electro-magnetic interference (EMI) Issue associated with a measure of electromagnetic radiation from equipment. EMI FDA C54451 Medical Device Problem Codes FDA CDRH C63005 Electronic property issue 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. FDA C54451 Medical Device Problem Codes FDA CDRH C63213 Electro-static discharge Issue associated with the discharge of electricity between two bodies previously electrically charged. FDA C54451 Medical Device Problem Codes FDA CDRH C63212 Emergency power failure FDA C54451 Medical Device Problem Codes FDA CDRH C63001 Energy output to patient tissue incorrect FDA C54451 Medical Device Problem Codes FDA CDRH C63000 Energy spectrum incorrect FDA C54451 Medical Device Problem Codes FDA CDRH C63210 Entrapment of device or device component Issue associated with the device and/or device accessories caught within patient vasculature or tissue. Entrapment FDA C54451 Medical Device Problem Codes FDA CDRH C63209 Environmental control or utility issue 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. FDA C54451 Medical Device Problem Codes FDA CDRH C63207 Erratic display Display, erratic FDA C54451 Medical Device Problem Codes FDA CDRH C63205 Error message given Issue associated with device providing messages relating to any deviations from documented performance specifications in software, hardware, and/or user interface. FDA C54451 Medical Device Problem Codes FDA CDRH C63204 Escape FDA C54451 Medical Device Problem Codes FDA CDRH C62882 Excess flow or overinfusion Overinfusion|Overdelivery FDA C54451 Medical Device Problem Codes FDA CDRH C63202 Excessive cooling Issue associated with device or device part overcool in device active (working) or/and non-active (non-working) states. The concept does not refer to the problem resulted from ambient temperature. FDA C54451 Medical Device Problem Codes FDA CDRH C63201 Excessive manipulation Issue associated with the use of the device in terms of exceeding mechanical and operational techniques as being non-conforming to the device's intended use, specifications, procedure and process or service instructions and information provided by the device manufacturers. FDA C54451 Medical Device Problem Codes FDA CDRH C63200 Exit block Issue associated with the identification of a conduction delay or failure immediately distal to a pacemaker site. FDA C54451 Medical Device Problem Codes FDA CDRH C62999 Expiration date error Issue associated with the erroneous notion that the device has exceeded its effective use-life under proper facility storage and handling conditions. FDA C54451 Medical Device Problem Codes FDA CDRH C62808 Facilities issue Issue associated with the physical establishment and environment in which medical devices are used. User facility issue FDA C54451 Medical Device Problem Codes FDA CDRH C63199 Fail-safe design failure Issue associated with the stated condition that the equipment will contain self-checking features, which will cause a function to cease in case of failure, malfunction, or drifting out of tolerance. FDA C54451 Medical Device Problem Codes FDA CDRH C62997 Fail-safe mechanism issue FDA C54451 Medical Device Problem Codes FDA CDRH C62989 Failure of device to self-test Issue associated with the incapability to perform any procedural examination by itself prior to use. FDA C54451 Medical Device Problem Codes FDA CDRH C63198 Failure to advance Issue associated with the inability to see a forward movement of the device and/or device components to an intended location. Advance, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63197 Failure to align Issue associated with a circuit, equipment, or system whereby its functions fail to be properly synchronized or its relative positions properly oriented. Align, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63196 Failure to analyze rhythm Rhythm, failure to analyze|Failure to diagnose rhythm|Rhythm, failure to diagnose FDA C54451 Medical Device Problem Codes FDA CDRH C62995 Failure to auto stop Issue associated with the inability of a device to turn itself off when the device is not in an operable condition. FDA C54451 Medical Device Problem Codes FDA CDRH C63195 Failure to back-up Issue associated with the inability to backup or to retrieve a backed up version (corrupted file) of device data or system files. Back-up, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C62994 Failure to calibrate Issue associated with the performance of the device to assure it complies with the appropriate specifications for precision and conforms to device standards. Calibrate, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C62993 Failure to capture Issue associated with the failure to achieve effective and consistent depolarization of the heart resulting from the electrical stimulus of the pacemaker. Capture, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63193 Failure to charge Issue associated with failure to register charge immediately after charging in relation to the apparent surface voltage present on an electrostatic recording medium. Charge, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63192 Failure to charge shock capacitors Issue associated with the failure to convert electric energy into chemical energy within the cell or battery, (in shock capacitators). Note: this restoration of the active materials is accomplished by maintaining a unidirectional current in the cell or battery in the opposite direction to that during discharge; a cell or battery that is said to be charged is understood to be fully charged. FDA C54451 Medical Device Problem Codes FDA CDRH C63191 Failure to conduct 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. Conduct, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63190 Failure to convert rhythm Rhythm, failure to convert FDA C54451 Medical Device Problem Codes FDA CDRH C63189 Failure to convert to back-up Back-up, failure to convert to FDA C54451 Medical Device Problem Codes FDA CDRH C63188 Failure to cut Cut, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63187 Failure to cycle Issue associated with the occurrence of total time used to carry out a complete sequence of operations fails. Cycle, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63186 Failure to deliver Deliver, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63185 Failure to deliver countershock Issues associated with the effective electromotive force within a system that fails to oppose the passage of current in a specified direction. Countershock, failure to deliver|Failure to countershock FDA C54451 Medical Device Problem Codes FDA CDRH C63184 Failure to deliver energy Energy, failure to deliver FDA C54451 Medical Device Problem Codes FDA CDRH C63183 Failure to deploy Issue associated with the inability of device and/or device components to be activated and positioned in a specified location. Deploy, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63182 Failure to diagnose rhythm Rhythm, failure to diagnose FDA C54451 Medical Device Problem Codes FDA CDRH C63181 Failure to discharge Issue associated with the failure to see a discontinuous movement of electrical charges through an insulating medium, initiated by electron avalanches and supplemented by secondary processes. Discharge, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63180 Failure to disconnect Issue associated with the linking of device and/or device components whereby the functional units set up to provide means for a transfer of liquid, gas, electricity, or information do not come apart, or disconnect, when expected. Disconnect, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63179 Failure to disinfect Disinfect, failure to|Disinfection, inadequate/improper FDA C54451 Medical Device Problem Codes FDA CDRH C63178 Failure to dry Dry, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63177 Failure to fire Fire, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63176 Failure to flush Flush, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63175 Failure to fold Fold, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C64328 Failure to form staple FDA C54451 Medical Device Problem Codes FDA CDRH C63174 Failure to infuse Infuse, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63173 Failure to interrogate Issue associated with the inability of a device and/or device components to interrogate by radar, by signal, or by a combination of signals necessary to trigger a response via transmitter and receiver interrogating system. Interrogate, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63172 Failure to obtain samples Samples, failure to obtain FDA C54451 Medical Device Problem Codes FDA CDRH C63171 Failure to osseointegrate 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. Osseointegrate, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63170 Failure to override rhythm Rhythm, failure to override FDA C54451 Medical Device Problem Codes FDA CDRH C63169 Failure to pace or properly pace 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. Pace, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C62992 Failure to power-up Power-up, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63168 Failure to prepare device Issue associated with the use of device characterized by unsuccessful attempts to make the device ready for use. Prep, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63167 Failure to prime Prime, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63166 Failure to program Program, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63165 Failure to pump Pump, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63164 Failure to read input signal Input signal, failure to read FDA C54451 Medical Device Problem Codes FDA CDRH C63241 Failure to recalibrate Recalibrate, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63163 Failure to remove enzymatic cleaner Enzymatic cleaner, failure to remove FDA C54451 Medical Device Problem Codes FDA CDRH C62991 Failure to reset Reset, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63162 Failure to run on AC/DC AC/DC, failure to run on FDA C54451 Medical Device Problem Codes FDA CDRH C62990 Failure to run on portable mode Portable mode, failure to run on FDA C54451 Medical Device Problem Codes FDA CDRH C63161 Failure to select signal Signal, failure to select FDA C54451 Medical Device Problem Codes FDA CDRH C63160 Failure to sense 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. Sensing, none FDA C54451 Medical Device Problem Codes FDA CDRH C63159 Failure to separate Issue associated with the inability of device and/or device components to become fully detached or broken from a mounted system, e.g., in interventional stenting procedures, the stent, once delivered to the correct and intended location, will normally deploy and separate from its mounting apparatus. Separate, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C62928 Failure to service Issue associated with the lack of periodic manufacturing service for checks of basic operation, maintenance, and fault finding. Service, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63158 Failure to shock or properly shock Issue associated with the inability of device and/or device components to provide a short duration of high force or high energy to a target location. Shock, failure to deliver FDA C54451 Medical Device Problem Codes FDA CDRH C62988 Failure to shut off FDA C54451 Medical Device Problem Codes FDA CDRH C63157 Failure to spike Issue associated with the distortion in the form of a pulse waveform of relatively short duration superimposed on an otherwise regular or desired pulse waveform. Spike, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63156 Failure to sterilize Sterilization, inadequate|Sterilization failure FDA C54451 Medical Device Problem Codes FDA CDRH C63155 Failure to transmit record Record, failure to transmit FDA C54451 Medical Device Problem Codes FDA CDRH C62949 Failure to unfold or unwrap 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. Difficult to unfold or unwrap FDA C54451 Medical Device Problem Codes FDA CDRH C63154 Failure to unwrap Issue associated with problems removing the materials used to construct the cover or outer wrapping of the device. Unwrap, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C62987 Failure to zero Zero, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63152 False alarm Issue associated with device providing incorrect alarm warning or alert to user. Alarm, false FDA C54451 Medical Device Problem Codes FDA CDRH C63151 False claim in device label Issue associated with 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, are inaccurate, and lack supporting data. Note that labeling can also include DVDs, discs, websites provided by device manufacturers. False claim FDA C54451 Medical Device Problem Codes FDA CDRH C63150 False device output False output FDA C54451 Medical Device Problem Codes FDA CDRH C63149 False negative result 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-negative test result FDA C54451 Medical Device Problem Codes FDA CDRH C63147 False positive result Issue associated with the device incorrectly reporting that something has been detected and misleads the operator to take certain actions. False-positive test result FDA C54451 Medical Device Problem Codes FDA CDRH C63145 False reading from device non-compliance Issue associated with the non-compliance of the device to meet its specific performance characteristics thereby causing a false reading. False readings FDA C54451 Medical Device Problem Codes FDA CDRH C63144 Filling problem Issue associated with the application of a material into a physical volume, e.g., tubing of an infusion pump or balloon catheter of an air pump. FDA C54451 Medical Device Problem Codes FDA CDRH C62986 Filtration issue 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. FDA C54451 Medical Device Problem Codes FDA CDRH C63143 Fire Issue associated with destructive burning or combustion of inflammable materials as manifested by any or all of the following: light, flame, heat, smoke. FDA C54451 Medical Device Problem Codes FDA CDRH C63142 Fitting problem 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. Fitting problems FDA C54451 Medical Device Problem Codes FDA CDRH C63141 Flaked Issue associated with the detachment of small pieces of the coating film of a material. Flaking|Flaked material FDA C54451 Medical Device Problem Codes FDA CDRH C63140 Flare or flash Issue associated with device-related burn with an unsteady flame. FDA C54451 Medical Device Problem Codes FDA CDRH C63139 Flashpoint threshold met Issue associated with approaching certain temperatures at which a combustible liquid ignites. FDA C54451 Medical Device Problem Codes FDA CDRH C63137 Fluid leak Fluid leak(s) FDA C54451 Medical Device Problem Codes FDA CDRH C63135 Fogging Issue associated with the visibility of water vapor in the immediate atmosphere in which the device is being used. FDA C54451 Medical Device Problem Codes FDA CDRH C63134 Folded Fold FDA C54451 Medical Device Problem Codes FDA CDRH C63133 Foreign material present in device Issue associated with the presence of materials, which are not part of the documented device specifications and requirements. Foreign material FDA C54451 Medical Device Problem Codes FDA CDRH C63132 Fracture Issue associated with any mechanical discontinuity in the material; it therefore is the collective term for joints, faults, cracks, etc. Fracture(s) of device/material FDA C54451 Medical Device Problem Codes FDA CDRH C63130 Free or unrestricted flow Issue associated with uncontrolled flow of infusion of air, gas or fluids. FDA C54451 Medical Device Problem Codes FDA CDRH C63129 Fumes or vapors Issue associated with the visibility or odor of vapor or gas in the immediate atmosphere in which the device is being used. Fumes/vapors FDA C54451 Medical Device Problem Codes FDA CDRH C63128 Fungus in device environment Issue associated with the visibility of molds, mildews, yeasts, and/or mushrooms in the immediate environment in which a device is being used. Fungus FDA C54451 Medical Device Problem Codes FDA CDRH C63127 Gas leak Issue associated with the unintended leakage of the state of matter in which the molecules are practically unrestricted by intermolecular forces so that the molecules are free to occupy all space within an enclosure. In vacuum technology, the word gas has been loosely applied to the uncondensed gas and vapor within a vacuum system. FDA C54451 Medical Device Problem Codes FDA CDRH C63316 Gel leak Gel leakage FDA C54451 Medical Device Problem Codes FDA CDRH C63126 Gradient increase Issue associated with the increased rate of change in temperature, pressure, or other variables as a function of distance, time, etc. FDA C54451 Medical Device Problem Codes FDA CDRH C63125 Grounding malfunction Issue associated with the inability to connect conductors of an electronic system for the purpose of controlling or impeding ground currents and voltages. FDA C54451 Medical Device Problem Codes FDA CDRH C64336 High battery impedance FDA C54451 Medical Device Problem Codes FDA CDRH C63124 High impedance Issue associated with a higher than intended total opposition that a circuit presents to the flow of an alternating current. Impedance, high FDA C54451 Medical Device Problem Codes FDA CDRH C62981 High pH pH, high FDA C54451 Medical Device Problem Codes FDA CDRH C63123 High Readings Readings, high FDA C54451 Medical Device Problem Codes FDA CDRH C63122 High test results Test results, high FDA C54451 Medical Device Problem Codes FDA CDRH C63121 High threshold Threshold, high FDA C54451 Medical Device Problem Codes FDA CDRH C63120 Hole in material Issue associated with an opening not characteristic of the normal material. Hole|Hole(s) FDA C54451 Medical Device Problem Codes FDA CDRH C63119 Hot oil leak FDA C54451 Medical Device Problem Codes FDA CDRH C63118 Human factors issue 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. FDA C54451 Medical Device Problem Codes FDA CDRH C63117 Image display error FDA C54451 Medical Device Problem Codes FDA CDRH C62887 Image orientation incorrect Issue associated with an incorrect image orientation on the device display. FDA C54451 Medical Device Problem Codes FDA CDRH C62871 Image resolution poor FDA C54451 Medical Device Problem Codes FDA CDRH C63115 Image reversal FDA C54451 Medical Device Problem Codes FDA CDRH C63114 Impedance issue Issue associated with the electrical characteristics of the complex resistive and reactive attributes of a component in an alternating current and direct current circuits. FDA C54451 Medical Device Problem Codes FDA CDRH C63113 Imprecision FDA C54451 Medical Device Problem Codes FDA CDRH C63112 Improper alarm FDA C54451 Medical Device Problem Codes FDA CDRH C63111 Improper chemical reaction Issue associated with inappropriate mixing of chemicals. FDA C54451 Medical Device Problem Codes FDA CDRH C63108 Improper device output Issue associated with the inaccurate outcome of a measurement, the value, or the data obtained from the device that may lead to inappropriate medical action or treatment. FDA C54451 Medical Device Problem Codes FDA CDRH C63107 Improper device rinsing Rinsing, improper FDA C54451 Medical Device Problem Codes FDA CDRH C63110 Improper flow or infusion 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. FDA C54451 Medical Device Problem Codes FDA CDRH C63109 Improper gas output Gas output, improper FDA C54451 Medical Device Problem Codes FDA CDRH C62862 Improper or incorrect procedure or method Issue associated with the use of the device in terms of non-conforming to that device's intended use, specifications, procedure and process or service instructions and information provided by the device manufacturers. Improper or incorrect method|Procedure, improper/incorrect|Method improper/incorrect FDA C54451 Medical Device Problem Codes FDA CDRH C63106 Inability to autofill Autofill, unable to FDA C54451 Medical Device Problem Codes FDA CDRH C63105 Inability to irrigate Irrigate, inability to FDA C54451 Medical Device Problem Codes FDA CDRH C63104 Inaccurate delivery Delivery, inaccurate FDA C54451 Medical Device Problem Codes FDA CDRH C63103 Inaccurate dispensing FDA C54451 Medical Device Problem Codes FDA CDRH C63102 Inaccurate flowrate Flowrate, inaccurate FDA C54451 Medical Device Problem Codes FDA CDRH C63101 Inaccurate synchronization Issue associated with an error due to imperfect timing of two operations; this may or may not include signal transmission time. Synchronization, inaccurate FDA C54451 Medical Device Problem Codes FDA CDRH C63099 Inadequate device cleaning 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. Clean, failure to|Cleaning, inadequate FDA C54451 Medical Device Problem Codes FDA CDRH C62985 Inadequate filtration process Filtration process, inadequate FDA C54451 Medical Device Problem Codes FDA CDRH C62870 Inadequate lighting Issue associated with insufficient or inadequate production of light or illumination in the immediate environment in which the device is being used, that may be damaging to device surfaces. FDA C54451 Medical Device Problem Codes FDA CDRH C63096 Inadequate resistance Resistance, inadequate FDA C54451 Medical Device Problem Codes FDA CDRH C63098 Inadequate service Issue associated with the insufficient periodic manufacturing services for checks of basic operation, maintenance, and fault finding. Service, inadequate FDA C54451 Medical Device Problem Codes FDA CDRH C63095 Inadequate storage Issue associated with adverse device storage conditions such as room temperature, humidity, light exposure, etc. Storage, inadequate|Storage inadequate FDA C54451 Medical Device Problem Codes FDA CDRH C63100 Inadequate user interface Issue associated with the means by which the operator and the equipment communicate or interact. FDA C54451 Medical Device Problem Codes FDA CDRH C63094 Inappropriate prompts Prompts, inappropriate FDA C54451 Medical Device Problem Codes FDA CDRH C63031 Inappropriate reset to default Issue associated with the inability to appropriately perform or generate any automated setting if no specific selection has made by the users. FDA C54451 Medical Device Problem Codes FDA CDRH C63093 Inappropriate shock Issue associated with the inappropriate occurrence of a short duration of a high force at the initial part of an impact. Shock, inappropriate FDA C54451 Medical Device Problem Codes FDA CDRH C63092 Inaudible voice prompts Prompts, inaudible voice FDA C54451 Medical Device Problem Codes FDA CDRH C62983 Incompatibility problem Issue associated with any deviations from device documented performance specifications relating to the lack of compatibility between items to properly function together and leading to dysfunction between two or more devices, components, or between the device and the substance (medication, body fluid) it contains or transports. This type excludes disconnection. Compatibility FDA C54451 Medical Device Problem Codes FDA CDRH C63090 Incomplete cooptation Issue associated with the heart valve leaflet not closing properly. FDA C54451 Medical Device Problem Codes FDA CDRH C63089 Incomplete instruction Issue associated with the completeness of 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. FDA C54451 Medical Device Problem Codes FDA CDRH C62940 Incomplete or missing packaging Packaging, incomplete/missing FDA C54451 Medical Device Problem Codes FDA CDRH C63318 Incorrect care or use of device Issue associated with any deviations from device documented performance specifications relating to device use in terms of non-conforming to that device's intended use, specifications, procedure, process, service instructions, and/or information provided by the device manufacturers. Device, incorrect care/use of FDA C54451 Medical Device Problem Codes FDA CDRH C63084 Incorrect component shipped Issue associated with the delivery of an inappropriate device component to a user facility. FDA C54451 Medical Device Problem Codes FDA CDRH C63264 Incorrect control settings 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. Control settings incorrect FDA C54451 Medical Device Problem Codes FDA CDRH C63088 Incorrect display Issue associated with device failure and malfunction when device does not display adequate results or have proper display. Display, incorrect FDA C54451 Medical Device Problem Codes FDA CDRH C63206 Incorrect error code FDA C54451 Medical Device Problem Codes FDA CDRH C63087 Incorrect instruction for device use 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. Instructions, incorrect FDA C54451 Medical Device Problem Codes FDA CDRH C63086 Incorrect interpretation of rhythm Rhythm, incorrect interpretation of FDA C54451 Medical Device Problem Codes FDA CDRH C63085 Incorrect measurement Measurements, inaccurate FDA C54451 Medical Device Problem Codes FDA CDRH C62848 Incorrect or inadequate result Issue associated with a non-conforming end result, data, or test results provided by the device to its performance specifications. Results incorrect FDA C54451 Medical Device Problem Codes FDA CDRH C62829 Incorrect or inadequate test results Test results, inaccurate FDA C54451 Medical Device Problem Codes FDA CDRH C63082 Incorrect product Product, incorrect FDA C54451 Medical Device Problem Codes FDA CDRH C63081 Incorrect programming calculations Programming calculations, incorrect FDA C54451 Medical Device Problem Codes FDA CDRH C63080 Increase in pressure Pressure, increase in FDA C54451 Medical Device Problem Codes FDA CDRH C63079 Increase in suction Aspiration, excessive|Excessive aspiration|Suction, increase in FDA C54451 Medical Device Problem Codes FDA CDRH C63136 Increased fluid or volume Fluid/volume, increased FDA C54451 Medical Device Problem Codes FDA CDRH C63077 Increased pump speed Pump speed, increased FDA C54451 Medical Device Problem Codes FDA CDRH C63078 Increased sensitivity Sensitivity, increased FDA C54451 Medical Device Problem Codes FDA CDRH C63076 Inflation issue Issue associated with the inability of device and/or device components to expand or enlarge with gas or air. Inflation difficulties FDA C54451 Medical Device Problem Codes FDA CDRH C63075 Infusion or flow issue Issue associated with any deviations from device documented performance specifications relating to the regulation and delivery of therapy, e.g., air, gas, drugs or fluids, into a device or patient under positive pressure that is being generated by a pump. FDA C54451 Medical Device Problem Codes FDA CDRH C63266 Ingradient or reagent contamination FDA C54451 Medical Device Problem Codes FDA CDRH C63074 Installation-related problem Issue associated with the introduction of the product into the hospital's organization and environment and the initial configuration of the device prior to use. Installation error FDA C54451 Medical Device Problem Codes FDA CDRH C63073 Instruction for device use is contrary to standard of medical care Issue associated with 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 depart from the standard of medical care in a given environment. FDA C54451 Medical Device Problem Codes FDA CDRH C63072 Instruction for use issue Issue associated with the accuracy and appropriateness of 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. Instructions, inadequate FDA C54451 Medical Device Problem Codes FDA CDRH C62912 Instruction missing Issue associated with the absence of any written, printed, or graphic matter that is typically affixed to a medical device or its containers, wrappers; or with any matter that typically accompanies a medical device including verbal instructions related to identification, technical description and use of the medical device. Excludes shipping documents which are provided by the device manufacturers. Missing device instruction FDA C54451 Medical Device Problem Codes FDA CDRH C63071 Insufficient cooling Issue associated with device or device parts being insufficiently cool in device active (working) or/and non-active (non-working) state. The concept does not refer to the problem resulted from ambient temperature. Cooling, inadequate FDA C54451 Medical Device Problem Codes FDA CDRH C62823 Insufficient flow or underinfusion Issue associated with an underdose of intravenous therapy, i.e., drugs or fluids being delivered into a patient under positive pressure generated by a pump. Underdelivery|Underinfusion FDA C54451 Medical Device Problem Codes FDA CDRH C63070 Insufficient heating Issue associated with device or device parts being insufficiently heated in device active (working) or/and non-active (non-working) state. The concept does not refer to the problem resulted from ambient temperature. Heating, inadequate FDA C54451 Medical Device Problem Codes FDA CDRH C63069 Intermittent capture Issue associated with the ineffective and inconsistent depolarization of the heart. Capture, intermittent FDA C54451 Medical Device Problem Codes FDA CDRH C63068 Intermittent continuity Continuity, intermittent FDA C54451 Medical Device Problem Codes FDA CDRH C63067 Intermittent infusion, Infusion, intermittent FDA C54451 Medical Device Problem Codes FDA CDRH C63064 Intermittent shock 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. Shock, intermittent FDA C54451 Medical Device Problem Codes FDA CDRH C63061 Invalid sensing Issue associated with the inaccuracy of a device designed to respond to a physical stimulus (as temperature, illumination, motion) to transmit a resulting signal that can not be used for interpretation or measurement. Sensing, invalid FDA C54451 Medical Device Problem Codes FDA CDRH C63019 Item contaminated during manufacturing or shipping 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. FDA C54451 Medical Device Problem Codes FDA CDRH C63060 Kinked Kink|Kinked material FDA C54451 Medical Device Problem Codes FDA CDRH C63059 Knotted Knot|Knotted material FDA C54451 Medical Device Problem Codes FDA CDRH C63319 Labeling or Instruction for use issue Issue associated with any written, printed, or graphic matter that is affixed to a medical device or its containers, wrappers, discs, DVDs, websites; with any matter that accompanies a medical device including verbal instructions related to identification, technical description and use of the medical device. Excludes shipping documents which are provided by the device manufacturers. FDA C54451 Medical Device Problem Codes FDA CDRH C63058 Leak Issue associated with the discontinuity of flow of gas, air, or fluids from a hole, or void in the wall of an enclosure, capable of passing liquid or gas from one side of the wall to the other under mechanical action of pressure or concentration differential existing across the wall, independent of the quantity of fluid flowing. Leak(s) FDA C54451 Medical Device Problem Codes FDA CDRH C63057 Light interference FDA C54451 Medical Device Problem Codes FDA CDRH C63056 Looping FDA C54451 Medical Device Problem Codes FDA CDRH C63055 Loose connection Connection(s), loose FDA C54451 Medical Device Problem Codes FDA CDRH C63054 Loss of augmentation Augmentation, loss of FDA C54451 Medical Device Problem Codes FDA CDRH C63194 Loss of or failure to bond Issue associated with a failure mode characterized by inability to bond or loss of bond either between the anchor and adhesive or between the adhesive and the base material. Bond, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C63053 Loss of osseointegration Osseointegration, loss of FDA C54451 Medical Device Problem Codes FDA CDRH C63052 Loss of power Issue associated with no power supply or electrical energy, including batteries that can provide power for the parent device or power to run auxiliary function, i.e. alarms, memory. Power, loss of FDA C54451 Medical Device Problem Codes FDA CDRH C63051 Loss of resistance Resistance, loss of FDA C54451 Medical Device Problem Codes FDA CDRH C63050 Loss of threshold Issue associated with the loss of the minimum amount of energy, voltage, or current needed to consistently stimulate the heart muscle. Threshold, loss of FDA C54451 Medical Device Problem Codes FDA CDRH C63049 Low audible alarm Alarm, low audible FDA C54451 Medical Device Problem Codes FDA CDRH C63048 Low battery Battery, low FDA C54451 Medical Device Problem Codes FDA CDRH C64335 Low battery impedance FDA C54451 Medical Device Problem Codes FDA CDRH C63047 Low impedance Issue associated with a lower than intended total opposition that a circuit presents to the flow of an alternating current. Impedance, low FDA C54451 Medical Device Problem Codes FDA CDRH C63046 Low readings Readings, low FDA C54451 Medical Device Problem Codes FDA CDRH C63045 Low test results Test results, low FDA C54451 Medical Device Problem Codes FDA CDRH C63044 Low threshold Threshold, low FDA C54451 Medical Device Problem Codes FDA CDRH C62978 Maintenance does not comply to manufacturers recommendations Issue associated with the non-compliance or non-performance 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. Maintenance not to manufacturers recommendations FDA C54451 Medical Device Problem Codes FDA CDRH C63043 Malposition of device Issue associated with device rotation in the pocket or is riding to high or low. Malposition FDA C54451 Medical Device Problem Codes FDA CDRH C63041 Manufacturing or shipping issue associated with device Issue associated with any deviations from device documented performance specifications relating to non-conformity during manufacture to the design of an item or to specified manufacturing processes. FDA C54451 Medical Device Problem Codes FDA CDRH C63248 Material deformation Issue associated with an undesired material change in shape or property caused by forces of compression, shear, tension, or torsion in the materials used for device construction. FDA C54451 Medical Device Problem Codes FDA CDRH C63224 Material discolored Issue associated with an undesired streak, pattern, and/or a noticeable change in color from the rest of the materials used in device construction. Discolored FDA C54451 Medical Device Problem Codes FDA CDRH C63222 Material disintegration Issue associated with material breakage into components or fragments after exposure to a given fluid and/or environment; the reduction of massive material to powder. Disintegrate FDA C54451 Medical Device Problem Codes FDA CDRH C63208 Material erosion Issue associated with a progressive loss of a material from a solid surface due to a mechanical interaction between that surface and a fluid, a multi-component fluid, or solid particles carried with the fluid. Erosion FDA C54451 Medical Device Problem Codes FDA CDRH C62969 Material fragmentation Issue associated with the breaking of a material in such a way the bulk of the material is of a convenient size for handling. Fragmentation FDA C54451 Medical Device Problem Codes FDA CDRH C63131 Material frayed Issue associated with the comprising materials having damaged edges. Frayed FDA C54451 Medical Device Problem Codes FDA CDRH C62968 Material integrity issue Issue associated with any deviations from device documented performance specifications relating to the limited durability of all material used to construct the device. FDA C54451 Medical Device Problem Codes FDA CDRH C63063 Material invagination Invagination FDA C54451 Medical Device Problem Codes FDA CDRH C62895 Material opacification Issue associated with an undesirable opaqueness or cloudiness. Opaque|Opacification FDA C54451 Medical Device Problem Codes FDA CDRH C62967 Material perforation Issue associated with an undesired material damage characterized by closely spaced punched or drilled holes. Perforation FDA C54451 Medical Device Problem Codes FDA CDRH C62966 Material puncture Issue associated with the comprising material(s) being penetrated, pierced or punctured, especially with a sharp or pointed object. Puncture FDA C54451 Medical Device Problem Codes FDA CDRH C62847 Material rigid or stiff Rigid|Rigid or stiff FDA C54451 Medical Device Problem Codes FDA CDRH C62965 Material rupture Issue associated with the breaking or tearing apart of a material. Rupture FDA C54451 Medical Device Problem Codes FDA CDRH C62964 Material separation Issue associated with an undesired disassociation or breaking apart of materials used in device construction. Separates|Separation FDA C54451 Medical Device Problem Codes FDA CDRH C64340 Material torqued Issue associated with a movement of forces that produces or tends to produce rotation or torsion of a material Torqued FDA C54451 Medical Device Problem Codes FDA CDRH C62962 Material twisted Twisting FDA C54451 Medical Device Problem Codes FDA CDRH C63040 Measurement system incompatibility 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. FDA C54451 Medical Device Problem Codes FDA CDRH C62961 Mechanical issue Issue associated with any deviations from device documented performance specifications relating to mechanical defects, including moving parts or subassemblies, etc. Mechanical failure FDA C54451 Medical Device Problem Codes FDA CDRH C63039 Mechanical jam Issue associated with a clogging action which can produce a chain stop of the device and/or device components' overall processes. FDA C54451 Medical Device Problem Codes FDA CDRH C62960 Mechanics altered Issue associated with device mechanical functioning of machinery, moving parts or tools of the device being changed or modified. FDA C54451 Medical Device Problem Codes FDA CDRH C62908 Melted Issue associated with the evidence of material softening, resulting in a nonreversible change. Material molten|Melts FDA C54451 Medical Device Problem Codes FDA CDRH C62918 Metal shredding debris Debris, metal shedding FDA C54451 Medical Device Problem Codes FDA CDRH C62917 Migration of device or device component Issue associated with an undesired movement of device and/or device components, related to its movement away from or dislodging from a source. Migration FDA C54451 Medical Device Problem Codes FDA CDRH C62959 Misapplied device Misapplication FDA C54451 Medical Device Problem Codes FDA CDRH C62958 Misassembled by users Issue associated with the use of the device characterized by users' incorrect assembly of device components, parts or constituents. Misassembly FDA C54451 Medical Device Problem Codes FDA CDRH C62915 Misconnection Issue associated with the connection of device and/or device components being improper or not in accordance with device specification, requirements and intended uses. Improper connection FDA C54451 Medical Device Problem Codes FDA CDRH C62914 Misfire Issue associated with device and/or device components' inability to create a blasting charge to explode when expected. FDA C54451 Medical Device Problem Codes FDA CDRH C62913 Misfocusing FDA C54451 Medical Device Problem Codes FDA CDRH C62911 Missing device label Labeling, missing FDA C54451 Medical Device Problem Codes FDA CDRH C62901 Missing device markings Markings, none|No markings on device FDA C54451 Medical Device Problem Codes FDA CDRH C62910 Moisture damage Issue associated with damage inflicted upon device surfaces from water vapor or water in the immediate environment in which the device is being used. FDA C54451 Medical Device Problem Codes FDA CDRH C62909 Moisture or humidity problem Issue associated with water vapor or higher than normal concentrations of water in the immediate environment in which the device is being used. FDA C54451 Medical Device Problem Codes FDA CDRH C62907 Mushroomed FDA C54451 Medical Device Problem Codes FDA CDRH C62906 Naturally worn 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. FDA C54451 Medical Device Problem Codes FDA CDRH C64343 No code available FDA C54451 Medical Device Problem Codes FDA CDRH C62900 No device output Issue associated with no measurement outcome, value, or data obtained from the device. Output, none FDA C54451 Medical Device Problem Codes FDA CDRH C62904 No display or display failure Issue associated with the absence of visual indicator. Display, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C62903 No fail-safe mechanism FDA C54451 Medical Device Problem Codes FDA CDRH C62902 No flow Issue associated with no intravenous therapy, i.e., drugs or fluids being delivered into a patient, even in the presence of positive pressure generated by a pump. FDA C54451 Medical Device Problem Codes FDA CDRH C53269 No Information Available No Answer Provided FDA C54451 Medical Device Problem Codes FDA CDRH C64243 No Pressure FDA C54451 Medical Device Problem Codes FDA CDRH C62899 No voice prompts Prompts, no voice FDA C54451 Medical Device Problem Codes FDA CDRH C62898 Nonstandard device or device component 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. FDA C54451 Medical Device Problem Codes FDA CDRH C48660 Not Applicable FDA C54451 Medical Device Problem Codes FDA CDRH C63310 Not audible alarm Alarm, not audible FDA C54451 Medical Device Problem Codes FDA CDRH C62897 Obstruction within device Obstruction FDA C54451 Medical Device Problem Codes FDA CDRH C62896 Occlusion within device Issue associated with obstruction, closure or blockage of device opening, pipe, tube or another narrow comprising part. Occlusion|Plugged FDA C54451 Medical Device Problem Codes FDA CDRH C62894 Operating system becomes non-functional Issue that occur as a result of malfunction of the computer operating system (e.g Microsoft Vista) vs. an application software issue. FDA C54451 Medical Device Problem Codes FDA CDRH C62893 Operating system version or upgrade problem Issue associated with replacing an older operation system to an up-to-date operation system. FDA C54451 Medical Device Problem Codes FDA CDRH C62892 Operator calculation or calibration error Issue associated with the use of the device in terms of erroneous calculation and/or miscalibration by users and/or operators of the device. FDA C54451 Medical Device Problem Codes FDA CDRH C62891 Optical decentration Issue associated with being off-center of optical lenses. Lens, decentration of FDA C54451 Medical Device Problem Codes FDA CDRH C62890 Optical discoloration 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. FDA C54451 Medical Device Problem Codes FDA CDRH C62889 Optical distortion 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. FDA C54451 Medical Device Problem Codes FDA CDRH C62953 Optical issue Issue associated with any deviations from device documented performance specifications relating to the luminous transmittance of visible light through the central pupillary (optical) area; or in short relating to light and vision characteristics of devices. FDA C54451 Medical Device Problem Codes FDA CDRH C62888 Optical obstruction Issue associated with the blocking of optical devices, e.g., visual pathways. FDA C54451 Medical Device Problem Codes FDA CDRH C62886 Osseointegration issue Issue associated with a mechanical implication that a contact is established without interposition of non-bone tissue between normal remodeled bone and an implant entailing a sustained transfer and distribution of load from the implant to and within the bone tissue. FDA C54451 Medical Device Problem Codes FDA CDRH C62944 Out-of-box failure FDA C54451 Medical Device Problem Codes FDA CDRH C62943 Output above specifications FDA C54451 Medical Device Problem Codes FDA CDRH C62942 Output below specifications FDA C54451 Medical Device Problem Codes FDA CDRH C63002 Output energy incorrect FDA C54451 Medical Device Problem Codes FDA CDRH C62941 Output issue Issue associated with any deviation from device documented performance specifications relating to the end result, data, or test results provided by the device. FDA C54451 Medical Device Problem Codes FDA CDRH C62884 Overfill FDA C54451 Medical Device Problem Codes FDA CDRH C62883 Overheating of device or device component Issue associated with the excessive heating or high temperature beyond the tolerance level such that the properties and structure undergo severe modification. Overheat FDA C54451 Medical Device Problem Codes FDA CDRH C62881 Oversensing FDA C54451 Medical Device Problem Codes FDA CDRH C62880 Pacer found in back-up mode FDA C54451 Medical Device Problem Codes FDA CDRH C63298 Pacing asynchronously 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. FDA C54451 Medical Device Problem Codes FDA CDRH C63097 Pacing inadequately Issue associated with an inadequate voltage generated by a ground current between two points on the surface of the ground at a distance apart corresponding to the conventional length of an ordinary pace. FDA C54451 Medical Device Problem Codes FDA CDRH C63066 Pacing intermittently 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. FDA C54451 Medical Device Problem Codes FDA CDRH C62939 Packaging issue Issue associated with the materials used to construct the cover or outer wrapping of the device. FDA C54451 Medical Device Problem Codes FDA CDRH C63083 Parameter calculation error due to software problem Parameter calculations, incorrect FDA C54451 Medical Device Problem Codes FDA CDRH C62879 Particulates 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. FDA C54451 Medical Device Problem Codes FDA CDRH C62919 Patient-device incompatibility Issue associated with the incompatibility of the device and patient while operating in the same use environment, thereby leading to a dysfunction between the device and the patient. FDA C54451 Medical Device Problem Codes FDA CDRH C62878 Peeled 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. Peeling|Peeled device material FDA C54451 Medical Device Problem Codes FDA CDRH C62876 Perivalvular leak Issue associated with the escape of blood around a heart valve, particularly around its leaflets. Leak(s), perivalvular|Paravalvular leak(s)|Paravalvular leak FDA C54451 Medical Device Problem Codes FDA CDRH C62937 Physical property issue 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. Device physical property issue FDA C54451 Medical Device Problem Codes FDA CDRH C62875 Physical resistance Resistance, physical FDA C54451 Medical Device Problem Codes FDA CDRH C62874 Pitted Issue associated with the corrosion of a material's surface, confined to a point or small area that takes the form of cavities. Pitting FDA C54451 Medical Device Problem Codes FDA CDRH C62873 Plunge FDA C54451 Medical Device Problem Codes FDA CDRH C62872 Pocket stimulation Issue associated with a pocket of skin in which the pulse generator is housed. FDA C54451 Medical Device Problem Codes FDA CDRH C62935 Polarity switch Issue associated with the output signal or power is reversed by physical or electrical means, e.g., in a multiple cell, series-connected battery this may be called cell reversal. Here, a cell is discharged completely and recharged with a reversed polarity by the continued discharge of the remaining cells. Device polarity switch FDA C54451 Medical Device Problem Codes FDA CDRH C62869 Poor quality image Issue associated with an image or any visual representation displayed by the device with non- distinctive characteristics. Monitor, image quality poor FDA C54451 Medical Device Problem Codes FDA CDRH C62916 Power calculation error due to software problem Power, miscalculation of FDA C54451 Medical Device Problem Codes FDA CDRH C63025 Power source issue FDA C54451 Medical Device Problem Codes FDA CDRH C62868 Power surge Issue associated with a momentary overpower/over voltage from the utility and electrical systems of user facilities. FDA C54451 Medical Device Problem Codes FDA CDRH C62867 Pre or post-pumping problem Pre/post-pumping problems FDA C54451 Medical Device Problem Codes FDA CDRH C62866 Precipitate in device or device ingredient Issue associated with the separation of solid particles from a liquid as the result of a chemical or physical change. Precipitate FDA C54451 Medical Device Problem Codes FDA CDRH C62863 Premature deployment Issue associated with an early and unexpected deployment of the device and/or device components from the system. Premature system activation FDA C54451 Medical Device Problem Codes FDA CDRH C62864 Premature discharge of battery Battery, premature discharge of FDA C54451 Medical Device Problem Codes FDA CDRH C63315 Premature elective replacement indicator Premature ERI FDA C54451 Medical Device Problem Codes FDA CDRH C63320 Premature end-of-life indicator Premature EOL FDA C54451 Medical Device Problem Codes FDA CDRH C62865 Premature indicator activation FDA C54451 Medical Device Problem Codes FDA CDRH C62934 Pressure issue Issue associated with the application of a force to a surface area during device preparation or use. FDA C54451 Medical Device Problem Codes FDA CDRH C62933 Pre-use inspection not performed Issue associated with the use of the device whereby a detailed examination or thorough visual and functional checking prior to use is absent. FDA C54451 Medical Device Problem Codes FDA CDRH C67507 Problem with software installation 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. FDA C54451 Medical Device Problem Codes FDA CDRH C62956 Product mislabeled Issue associated with the misbranding or false labeling of an operating system, product, or device. Mislabeled FDA C54451 Medical Device Problem Codes FDA CDRH C62948 Product quality issue Issue associated with an inherited device and/or device component characteristic that may not be satisfactory as specified. Device or device component quality issue|Quality, unsatisfactory or poor FDA C54451 Medical Device Problem Codes FDA CDRH C62839 Programming issue Issue associated with the written program code the application software used to satisfy a stated need or objective for functioning of the deivce. These do not include issues associated with the operating system (e.g. MS Vista). FDA C54451 Medical Device Problem Codes FDA CDRH C62861 Prompts will not clear FDA C54451 Medical Device Problem Codes FDA CDRH C62932 Protective measure issue 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, or maintaining risks within, specified levels of the device. FDA C54451 Medical Device Problem Codes FDA CDRH C62860 Pumping issue Issue associated with the inability to achieve positive pressure from the device and/or device components in order to deliver intravenous therapy such i.e. drugs or fluids to patients. FDA C54451 Medical Device Problem Codes FDA CDRH C62859 Pumping stopped Pumping, stopped FDA C54451 Medical Device Problem Codes FDA CDRH C62858 Radiation delivered to incorrect body area FDA C54451 Medical Device Problem Codes FDA CDRH C62857 Radiation leak Leak, radiation FDA C54451 Medical Device Problem Codes FDA CDRH C62856 Radio signal problem Issue associated with the wireless transmission signal in the lowest range of the electromagnetic spectrum. Radio signal problems FDA C54451 Medical Device Problem Codes FDA CDRH C62855 Radiofrequency interference (RFI) Issue associated with the degradation of the reception of a wanted signal caused by RF disturbance. RFI FDA C54451 Medical Device Problem Codes FDA CDRH C62854 Reflux within device Issue associated with a backward or return flow. Reflux FDA C54451 Medical Device Problem Codes FDA CDRH C62853 Rejection FDA C54451 Medical Device Problem Codes FDA CDRH C62852 Reset issue Issue associated with setting a variable, register, or other storage location back to a prescribed state. FDA C54451 Medical Device Problem Codes FDA CDRH C62851 Resetting of shock counters Issue associated with a device such as a register or storage location used to represent the number of occurrences of an event, such as shock delivery, resets itself without any instruction to do so; an instrument for storing integers, permitting these integers to be increased or decreased sequentially by unity or by an arbitrary integer, and capable of being reset to zero or to an arbitrary integer. Shock counters, resetting of FDA C54451 Medical Device Problem Codes FDA CDRH C62850 Residue after decontamination Issue associated with the presence of unwanted visible soil, foreign material, or organism deposits after the decontamination process. Residue FDA C54451 Medical Device Problem Codes FDA CDRH C62849 Restricted flowrate Flowrate, restricted FDA C54451 Medical Device Problem Codes FDA CDRH C62929 Retraction problem Issue associated with drawing back the device and/or device component to an intended location. Retract, failure to FDA C54451 Medical Device Problem Codes FDA CDRH C62846 Scratched material Issue associated with an undesirable shallow cut or narrow groove in the surface of the materials used in device construction. Scratched FDA C54451 Medical Device Problem Codes FDA CDRH C62845 Sediment, precipitate or deposit in device or device igredient FDA C54451 Medical Device Problem Codes FDA CDRH C62844 Self-activation or keying Issue associated with the unintended activation of device, or device having been unexpectedly turned on during use. Self-activation/keying FDA C54451 Medical Device Problem Codes FDA CDRH C63065 Sensing intermittently FDA C54451 Medical Device Problem Codes FDA CDRH C62926 Shelf life exceeded Issue associated with surpassing the length of time which packaged device materials can be stored under specified conditions and still remain effective in use. FDA C54451 Medical Device Problem Codes FDA CDRH C62842 Shielding failure Issue associated with device inability to act as a barrier for absorption of radiation energy in X-rays, gamma rays, etc. FDA C54451 Medical Device Problem Codes FDA CDRH C62925 Shipping damage or problem FDA C54451 Medical Device Problem Codes FDA CDRH C62841 Short fill FDA C54451 Medical Device Problem Codes FDA CDRH C62947 Size incorrect for patient Size, incorrect FDA C54451 Medical Device Problem Codes FDA CDRH C62840 Slippage of device or device component Slippage FDA C54451 Medical Device Problem Codes FDA CDRH C63003 Smoking Issue associated with a cloud of vapor or gas generated from the device, generally associated after a fire or a burn. Smoke FDA C54451 Medical Device Problem Codes FDA CDRH C62838 Solder joint failure FDA C54451 Medical Device Problem Codes FDA CDRH C62837 Spark Issue associated with a high voltage capacitor discharge characterized by a visible electrical glowing. FDA C54451 Medical Device Problem Codes FDA CDRH C62963 Split 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. Material split|Splitting FDA C54451 Medical Device Problem Codes FDA CDRH C62836 Sticking FDA C54451 Medical Device Problem Codes FDA CDRH C62835 Stretched Issue associated with an increase or elongation in a materials' dimension. Material stretched FDA C54451 Medical Device Problem Codes FDA CDRH C62834 Strikethrough FDA C54451 Medical Device Problem Codes FDA CDRH C62923 Structural problem Issue associated with the basic physical construction or physical make up of the device. Structural failure FDA C54451 Medical Device Problem Codes FDA CDRH C62833 Suction issue 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. Suction failure FDA C54451 Medical Device Problem Codes FDA CDRH C62831 Tear, rip or hole in device packaging Packaging, tears, rips, holes in FDA C54451 Medical Device Problem Codes FDA CDRH C62830 Telemetry discrepancy 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. FDA C54451 Medical Device Problem Codes FDA CDRH C62922 Temperature issue Issue associated any deviations from device documented performance specifications relating to the thermal state of the device operations as measured on a defined scale. FDA C54451 Medical Device Problem Codes FDA CDRH C62828 Therapeutic or diagnostic output failure Issue associated with the failure of the device to deliver any end results relating to treatment or identification of a disease. FDA C54451 Medical Device Problem Codes FDA CDRH C63138 Tidal volume fluctuations Issue associated with the amount of gas that is inspired and expired during one respiratory cycle. FDA C54451 Medical Device Problem Codes FDA CDRH C62921 Tipover Device tipover FDA C54451 Medical Device Problem Codes FDA CDRH C62832 Torn material Issue associated with comprising material(s) being pulled apart or into pieces by force, wrenching, or laceration. FDA C54451 Medical Device Problem Codes FDA CDRH C62827 Ultrafiltration Issue associated with the transfer of fluid between the blood and dialysate through the dialysis membrane due to a pressure gradient (transmembrane pressure) existing between the blood and dialysate compartments. FDA C54451 Medical Device Problem Codes FDA CDRH C62826 Unable to obtain readings Readings, unable to obtain FDA C54451 Medical Device Problem Codes FDA CDRH C63259 Unauthorized access to computer system 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. FDA C54451 Medical Device Problem Codes FDA CDRH C62825 Uncoiled FDA C54451 Medical Device Problem Codes FDA CDRH C62822 Undersensing FDA C54451 Medical Device Problem Codes FDA CDRH C62821 Unexpected therapeutic results Issue associated with the use of a medical device for therapeutic purposes. Therapeutic results, unexpected FDA C54451 Medical Device Problem Codes FDA CDRH C62820 Unintended arm motion Arm motion, unintended FDA C54451 Medical Device Problem Codes FDA CDRH C62819 Unintended collision Issue associated with an unwanted condition that results from concurrent transmission on the physical medium. Collision, unintended FDA C54451 Medical Device Problem Codes FDA CDRH C62817 Unintended ejection of film cartridge Film cartridge ejection, unintended FDA C54451 Medical Device Problem Codes FDA CDRH C62818 Unintended energization Device energization, unintended|Unintended device energization FDA C54451 Medical Device Problem Codes FDA CDRH C62816 Unintended head motion Head motion, unintended FDA C54451 Medical Device Problem Codes FDA CDRH C62815 Unintended magnet quench Magnet quench, unintended FDA C54451 Medical Device Problem Codes FDA CDRH C62814 Unintended movement Issue associated with an undesired movement of device, which may be related to device malfunction, misdiagnosis, or mistreatment. FDA C54451 Medical Device Problem Codes FDA CDRH C62813 Unintended system motion Issue associated with any motion of the system or components that was not initiated by the user. System motion, unintended FDA C54451 Medical Device Problem Codes FDA CDRH C62812 Unit inactivated FDA C54451 Medical Device Problem Codes FDA CDRH C17998 Unknown Unknown|Unknown (for use when the device problem is not known)|Unknown (For Use When The Patients Condition Is Not Known) FDA C54451 Medical Device Problem Codes FDA CDRH C62811 Unraveled material FDA C54451 Medical Device Problem Codes FDA CDRH C62810 Unsealed device packaging Packaging, unsealed FDA C54451 Medical Device Problem Codes FDA CDRH C62809 Unstable Issue associated with the connection of device and/or device components not possessing stability, or is unbounded. FDA C54451 Medical Device Problem Codes FDA CDRH C62807 Ventilation issue in device environment FDA C54451 Medical Device Problem Codes FDA CDRH C62806 Vibration Issue associated with an oscillation wherein the quantity is a parameter that defines the motion of a mechanical system. FDA C54451 Medical Device Problem Codes FDA CDRH C62805 Volume accuracy issue Volume accuracy FDA C54451 Medical Device Problem Codes FDA CDRH C62804 Wrinkled Wrinkling|Wrinkled material FDA C54450 Patient Problem Codes FDA CDRH C34331 Abdominal Cramps Cramps, abdominal FDA C54450 Patient Problem Codes FDA CDRH C35221 Abortion FDA C54450 Patient Problem Codes FDA CDRH C50500 Abortion, Complete All products of conception are expelled and identified. FDA C54450 Patient Problem Codes FDA CDRH C50608 Abortion, Incomplete The uterus is not entirely emptied of its contents. FDA C54450 Patient Problem Codes FDA CDRH C50613 Abortion, Inducedl Abortion brought on intentionally. Abortion, Artificial|Artificial abortion|Induced abortion FDA C54450 Patient Problem Codes FDA CDRH C50652 Abortion, Missed Retention in uterus of an abortus that has been dead at least 4 weeks. FDA C54450 Patient Problem Codes FDA CDRH C34338 Abortion, Therapeutic FDA C54450 Patient Problem Codes FDA CDRH C50449 Abrasion Abraded wound; excoriation or circumscribed removal of the superficial layers of the skin or mucous membrane. FDA C54450 Patient Problem Codes FDA CDRH C26686 Abscess FDA C54450 Patient Problem Codes FDA CDRH C50451 Achalasia Failure of the smooth muscle fibers of the gastrointestinal tract to relax at any one point of junction of one part with another. FDA C54450 Patient Problem Codes FDA CDRH C50453 Acoustic Trauma FDA C54450 Patient Problem Codes FDA CDRH C54685 Adhesion(s) FDA C54450 Patient Problem Codes FDA CDRH C3353 Adult Respiratory Distress Syndrome ARDS|Adult respiratory distress syndrome, ARDS FDA C54450 Patient Problem Codes FDA CDRH C2851 AIDS, Acquired Immunodeficiency Syndrome A disease characterized by opportunistic infections. Acquired immunodeficiency syndrome, AIDS FDA C54450 Patient Problem Codes FDA CDRH C50455 Air Embolism The presence of bubbles of gas in the vascular system; occurrence is related to the entry of air into the venous circulation following trauma or surgery. FDA C54450 Patient Problem Codes FDA CDRH C50730 Airflow, Restricted FDA C54450 Patient Problem Codes FDA CDRH C50456 Airway Obstruction FDA C54450 Patient Problem Codes FDA CDRH C50458 Ambulation Difficulties Difficulties, ambulation FDA C54450 Patient Problem Codes FDA CDRH C50459 Amnionitis Inflammation of the amnion. FDA C54450 Patient Problem Codes FDA CDRH C15179 Amputation FDA C54450 Patient Problem Codes FDA CDRH C50410 Anaphylactoid FDA C54450 Patient Problem Codes FDA CDRH C50417 Anastomose, Failure To FDA C54450 Patient Problem Codes FDA CDRH C15609 Anastomosis FDA C54450 Patient Problem Codes FDA CDRH C2869 Anemia FDA C54450 Patient Problem Codes FDA CDRH C51220 Anesthesia, insufficient, light or patchy Light, patchy or insufficient anesthesia|Patchy, light or insufficient anesthesia|Insufficient, light or patchy anesthesia FDA C54450 Patient Problem Codes FDA CDRH C26693 Aneurysm FDA C54450 Patient Problem Codes FDA CDRH C51221 Angina FDA C54450 Patient Problem Codes FDA CDRH C2876 Anoxia FDA C54450 Patient Problem Codes FDA CDRH C51222 Antibiotics, reaction to FDA C54450 Patient Problem Codes FDA CDRH C16299 Anticoagulation FDA C54450 Patient Problem Codes FDA CDRH C26696 Anxiety FDA C54450 Patient Problem Codes FDA CDRH C50461 Aortic Dissection Dissection, Aortic FDA C54450 Patient Problem Codes FDA CDRH C51223 Aortic insufficiency FDA C54450 Patient Problem Codes FDA CDRH C50861 Aortic Regurgitation The backward flow of blood from the aorta into the left ventricle, owing to insufficiency of the aortic semilunar valve; it may be chronic or acute. FDA C54450 Patient Problem Codes FDA CDRH C50462 Aortic Stenosis Narrowing of the orifice of the aortic valve or of the supravalvular or subvalvular regions. FDA C54450 Patient Problem Codes FDA CDRH C50815 Aortic Valve Replacement Replacement of aortic valve|Valve, replacement of aortic FDA C54450 Patient Problem Codes FDA CDRH C50416 Apgar Score, Decreased Or Low Low or decreased apgar score|Score, decreased or low apgar|Decreased or low apgar score FDA C54450 Patient Problem Codes FDA CDRH C15191 Apheresis FDA C54450 Patient Problem Codes FDA CDRH C50824 Apicectomy FDA C54450 Patient Problem Codes FDA CDRH C26698 Apnea Cessation of breathing. Arrest, respiratory|Respiratory Arrest FDA C54450 Patient Problem Codes FDA CDRH C50749 Arachnoiditis, Spinal A chronic adhesive arachnoiditis in the spinal arachnoid, with root and spinal cord symptoms similar to those caused by pressure from a tumor. FDA C54450 Patient Problem Codes FDA CDRH C2881 Arrhythmia FDA C54450 Patient Problem Codes FDA CDRH C34398 Arteriosclerosis FDA C54450 Patient Problem Codes FDA CDRH C50464 Arthralgia Pain in a joint. Pain, joint|Joint pain FDA C54450 Patient Problem Codes FDA CDRH C2883 Arthritis FDA C54450 Patient Problem Codes FDA CDRH C2884 Arthritis, Rheumatoid Rheumatoid Arthritis FDA C54450 Patient Problem Codes FDA CDRH C2885 Ascites FDA C54450 Patient Problem Codes FDA CDRH C50465 Asphyxia A condition due to lack of oxygen in respired air, resulting in impending or actual cessation of life. FDA C54450 Patient Problem Codes FDA CDRH C50561 Asphyxia, Fetal Asphyxia in utero due to hypoxia. See also fetal hypoxia. Fetal asphyxia FDA C54450 Patient Problem Codes FDA CDRH C28245 Aspiration FDA C54450 Patient Problem Codes FDA CDRH C28397 Asthma FDA C54450 Patient Problem Codes FDA CDRH C35768 Atherosclerosis FDA C54450 Patient Problem Codes FDA CDRH C50466 Atrial Fibrillation An arrhythmia in which minute areas of the atrial myocardium are in various uncoordinated stages of depolarization and repolarization; instead of intermittently contracting, the atria quiver continuously in a chaotic pattern, causing a totally irregular, often rapid ventricular rate. FDA C54450 Patient Problem Codes FDA CDRH C51224 Atrial Flutter FDA C54450 Patient Problem Codes FDA CDRH C50467 Atrial Perforation FDA C54450 Patient Problem Codes FDA CDRH C35481 Atrial Tachycardia FDA C54450 Patient Problem Codes FDA CDRH C2889 Autoimmune Disease Disease, autoimmune FDA C54450 Patient Problem Codes FDA CDRH C16313 Autoimmune reaction Reaction, autoimmune FDA C54450 Patient Problem Codes FDA CDRH C50870 Autotransfusion Reinfusion of blood or blood products derived from the patient's own circulation. FDA C54450 Patient Problem Codes FDA CDRH C51225 Biliary Cirrhosis Cirrhosis, biliary FDA C54450 Patient Problem Codes FDA CDRH C50551 Blinking, Excessive Excessive blinking FDA C54450 Patient Problem Codes FDA CDRH C50468 Blockage FDA C54450 Patient Problem Codes FDA CDRH C50447 Blood Gas Measurements, Abnormal Abnormal blood gas measurements|Measurements, abnormal blood gas FDA C54450 Patient Problem Codes FDA CDRH C50470 Blood loss Loss of blood FDA C54450 Patient Problem Codes FDA CDRH C50471 Blood pooling Unintended collection/stasis of blood in patient. Pooling of blood FDA C54450 Patient Problem Codes FDA CDRH C27123 Blurred vision Vision, Blurring Of|Blurring FDA C54450 Patient Problem Codes FDA CDRH C50442 Body Temperature, Elevated Elevation of total body temperature. Core Temperature Rise|Elevated body temperature|Temperature rise, core|Temperature, elevated body|Rise in core temperature FDA C54450 Patient Problem Codes FDA CDRH C39611 Bowel Perforation FDA C54450 Patient Problem Codes FDA CDRH C37920 Bradycardia Heart Rate, Decreased|Decreased heart rate FDA C54450 Patient Problem Codes FDA CDRH C50440 Brain Injury Brain Damage|Injury, brain FDA C54450 Patient Problem Codes FDA CDRH C50604 Breast Feed, Inability To Inability to breast feed FDA C54450 Patient Problem Codes FDA CDRH C3197 Breast Lumps Lumps, breast FDA C54450 Patient Problem Codes FDA CDRH C2910 Breast Neoplasm Neoplasm, breast FDA C54450 Patient Problem Codes FDA CDRH C2911 Bronchitis FDA C54450 Patient Problem Codes FDA CDRH C26710 Bronchopneumonia FDA C54450 Patient Problem Codes FDA CDRH C34439 Bronchospasm FDA C54450 Patient Problem Codes FDA CDRH C37921 Bruise FDA C54450 Patient Problem Codes FDA CDRH C34441 Burn(s) Injury to tissues caused by contact with dry heat, moist heat, flames, chemicals, electricity, friction or radiant and electromagnetic energy. A first degree burn is associated with redness, a second degree burn with vesication and a third degree burn with necrosis through the entire skin. FDA C54450 Patient Problem Codes FDA CDRH C50473 Burn, Bowel Bowel burn FDA C54450 Patient Problem Codes FDA CDRH C50506 Burn, Corneal Corneal burn FDA C54450 Patient Problem Codes FDA CDRH C50606 Burn, Incisional Incisional burn FDA C54450 Patient Problem Codes FDA CDRH C50768 Burn, thermal Thermal burn|Burns, Thermal FDA C54450 Patient Problem Codes FDA CDRH C50476 Burning Sensation Sensation, burning FDA C54450 Patient Problem Codes FDA CDRH C3672 Calcification Deposit(s), calcium|Calcium Deposit(s) FDA C54450 Patient Problem Codes FDA CDRH C4872 Cancer, Breast Breast cancer FDA C54450 Patient Problem Codes FDA CDRH C50477 Cancer, Other FDA C54450 Patient Problem Codes FDA CDRH C50702 Capsular Bag Tear, Posterior FDA C54450 Patient Problem Codes FDA CDRH C50479 Cardiac Arrest Sudden cessation of the pumping function of the heart, with disappearance of arterial blood pressure, connoting either ventricular fibrillation or ventricular standstill. Arrest, cardiac|Asystole FDA C54450 Patient Problem Codes FDA CDRH C50481 Cardiac Tamponade Acute compression of the heart caused by increased intrapericardial pressure due to the collection of blood or fluid in the pericardium from rupture of the heart, penetrating trauma, or progressive effusion. FDA C54450 Patient Problem Codes FDA CDRH C34830 Cardiomyopathy FDA C54450 Patient Problem Codes FDA CDRH C50483 Cardiopulmonary Arrest Cessation of breathing and/or cardiac function. Arrest, cardiopulmonary FDA C54450 Patient Problem Codes FDA CDRH C26713 Cataract FDA C54450 Patient Problem Codes FDA CDRH C50614 Cataract, Induced A cataract that has been produced artificially or by induction, e.g. as a result of device use, medication, trauma, tears, falls, accidental injury, etc. Induced cataract FDA C54450 Patient Problem Codes FDA CDRH C38045 Catheterization FDA C54450 Patient Problem Codes FDA CDRH C34442 Caustic/Chemical Burns Burn, caustic/chemical|Chemical/caustic burn FDA C54450 Patient Problem Codes FDA CDRH C26715 Cellulitis FDA C54450 Patient Problem Codes FDA CDRH C50484 Cephalohematoma A subperiosteal hemorrhage limited to the surface of one cranial bone, a usually benign condition seen in the newborn as a result of bone trauma. FDA C54450 Patient Problem Codes FDA CDRH C50487 Cerebrospinal Fluid Leakage Leakage of cerebrospinal fluid|Fluid, leakage of cerebrospinal FDA C54450 Patient Problem Codes FDA CDRH C3390 Cerebrovascular Accident CVA, Cerebrovascular accident|CVA|Cerebrovascular accident, (CVA)|Stroke|Syndrome, stroke|Stroke Syndrome FDA C54450 Patient Problem Codes FDA CDRH C50488 Cervical Changes Changes such as abnormal, pathological, benign, malignant, etc. Cervical Change|Changes, cervical FDA C54450 Patient Problem Codes FDA CDRH C46088 Cesarean Section (c-section) Delivery by cesarean section (c-section)|C-section (cesarean section), delivery by FDA C54450 Patient Problem Codes FDA CDRH C36290 Chemical Exposure Exposure, chemical FDA C54450 Patient Problem Codes FDA CDRH C50490 Chemosis Excessive edema of the ocular conjunctiva. FDA C54450 Patient Problem Codes FDA CDRH C38665 Chest Pain Pain in chest FDA C54450 Patient Problem Codes FDA CDRH C50491 Chest Tightness/Pressure Pressure/tightness in chest|Tightness/pressure in chest FDA C54450 Patient Problem Codes FDA CDRH C35143 Chills FDA C54450 Patient Problem Codes FDA CDRH C50494 Choking FDA C54450 Patient Problem Codes FDA CDRH C26720 Chorioamnionitis FDA C54450 Patient Problem Codes FDA CDRH C3199 Chronic obstructive pulmonary disease, (COPD) Disease (COPD), chronic obstructive|Pulmonary disease (COPD), chronic obstructive|Obstructive pulmonary disease (COPD), chronic|COPD, chronic obstructive pulmonary disease FDA C54450 Patient Problem Codes FDA CDRH C50600 Circulation, Impaired Impaired circulation FDA C54450 Patient Problem Codes FDA CDRH C50495 Claudication Limping or lameness. FDA C54450 Patient Problem Codes FDA CDRH C50834 Closed Capsulotomy FDA C54450 Patient Problem Codes FDA CDRH C34455 Clouding, Central Corneal Diffuse edema of the central region of the cornea, usually associated with the wearing of hard contact lenses, but may also occur in keratoconus. Corneal clouding, central|Central corneal clouding FDA C54450 Patient Problem Codes FDA CDRH C20812 Coagulation Clotting FDA C54450 Patient Problem Codes FDA CDRH C2902 Coagulopathy FDA C54450 Patient Problem Codes FDA CDRH C50457 Cognitive Changes Pertaining to or characterized by cognition. That operation of the mind which we become aware of objects of thought or perception; it includes all aspects of perceiving, thinking, or remembering. Changes, cognitive FDA C54450 Patient Problem Codes FDA CDRH C50497 Collapse FDA C54450 Patient Problem Codes FDA CDRH C15211 Colostomy FDA C54450 Patient Problem Codes FDA CDRH C34497 Coma Comatose FDA C54450 Patient Problem Codes FDA CDRH C50499 Complaint, Ill-Defined Ill-defined complaint FDA C54450 Patient Problem Codes FDA CDRH C50501 Complete Heart Block FDA C54450 Patient Problem Codes FDA CDRH C50502 Concussion A violent jar or shock, or the condition which results from such an injury. FDA C54450 Patient Problem Codes FDA CDRH C37928 Confusion/Disorientation Disorientation/confusion FDA C54450 Patient Problem Codes FDA CDRH C2849 Congenital Defect/Deformity Deformity/defect, congenital|Defect/deformity, congenital FDA C54450 Patient Problem Codes FDA CDRH C3080 Congestive Heart Failure Failure, congestive heart|Heart failure, congestive FDA C54450 Patient Problem Codes FDA CDRH C34504 Conjunctivitis FDA C54450 Patient Problem Codes FDA CDRH C26729 Connective Tissue Disease Disease, connective tissue|Tissue disease, connective FDA C54450 Patient Problem Codes FDA CDRH C50505 Contamination From Blood/Fluids The patient becomes contaminated from contact with blood/fluids on a device. Blood/fluids, contamination from|Fluids/blood, contamination from FDA C54450 Patient Problem Codes FDA CDRH C50690 Contamination, Chemical Patient becomes contaminated from exposure to chemicals associated with the use of the device, including chemical spills from a device. Chemical contamination FDA C54450 Patient Problem Codes FDA CDRH C50646 Contraindication Any special symptom or circumstance that renders the use of a remedy or the carrying out of a procedure inadvisable, usually because of the risk. Contraindicated patient|Patient, contraindicated FDA C54450 Patient Problem Codes FDA CDRH C50441 Contusion A bruise; an injury of a part without a break in the skin. FDA C54450 Patient Problem Codes FDA CDRH C50496 Convulsion, Clonic A convulsion marked by alternating contracting and relaxing of the muscles. Clonic convulsion FDA C54450 Patient Problem Codes FDA CDRH C50776 Convulsion, Tonic Prolonged contraction of the muscles, as the result of an epileptic discharge. Tonic convulsion FDA C54450 Patient Problem Codes FDA CDRH C50692 Cornea, Perforation Of Perforation of cornea FDA C54450 Patient Problem Codes FDA CDRH C26730 Corneal Abrasion FDA C54450 Patient Problem Codes FDA CDRH C50507 Corneal Decompensation Inability to maintain corneal integrity; or corneal edema resulting from failure of the corneal endothelium to maintain detumescence. Decompensation, corneal FDA C54450 Patient Problem Codes FDA CDRH C50508 Corneal Edema Hazy, swollen cornea. Edema, corneal FDA C54450 Patient Problem Codes FDA CDRH C50919 Corneal Implant Implant, corneal FDA C54450 Patient Problem Codes FDA CDRH C50510 Corneal Infiltrates Discrete, small lesions present in the cornea as a result of corneal inflammation and, in some cases, after soft contact lens wear especially extended-wear lenses. Infiltrates, corneal FDA C54450 Patient Problem Codes FDA CDRH C50511 Corneal Scar Scar, corneal FDA C54450 Patient Problem Codes FDA CDRH C50512 Corneal Sensitivity The capability of the cornea to respond to stimulation. Sensitivity, corneal FDA C54450 Patient Problem Codes FDA CDRH C50513 Corneal Touch Complications of intraocular lens surgery; usually refers to intraocular lens contact with cornea, can be intermittent or chronic. Touch, corneal FDA C54450 Patient Problem Codes FDA CDRH C50514 Corneal Transplant Transplant, corneal FDA C54450 Patient Problem Codes FDA CDRH C50515 Corneal Ulcer Area of epithelial tissue loss from corneal surface; associated with inflammatory cells in the cornea and anterior chamber. Ulcer, corneal FDA C54450 Patient Problem Codes FDA CDRH C50516 Corneal Whitening Whitening, corneal FDA C54450 Patient Problem Codes FDA CDRH C34827 Cramp(s) FDA C54450 Patient Problem Codes FDA CDRH C35375 Crushing Injury Injury, crushing FDA C54450 Patient Problem Codes FDA CDRH C50517 Cusp Tear FDA C54450 Patient Problem Codes FDA CDRH C50518 Cut(s) FDA C54450 Patient Problem Codes FDA CDRH C26737 Cyanosis FDA C54450 Patient Problem Codes FDA CDRH C50519 Cyclitis Inflammation of the ciliary body. FDA C54450 Patient Problem Codes FDA CDRH C50520 Cyst(s), Formation Of Formation of cyst(s) FDA C54450 Patient Problem Codes FDA CDRH C50521 Cytomegaloviral Retinitis Retinitis, cytomegaloviral FDA C54450 Patient Problem Codes FDA CDRH C14196 Cytomegalovirus (CVM) CMV, cytomegalovirus FDA C54450 Patient Problem Codes FDA CDRH C27644 Deafness FDA C54450 Patient Problem Codes FDA CDRH C50620 Death, Intrauterine Fetal Death in utero; failure of the product of conception to show evidence of respiration, heart beat, or definite movement of a voluntary muscle after expulsion from the uterus, with no possibility of resuscitation. Fetal death, intrauterinel|Intrauterine fetal death FDA C54450 Patient Problem Codes FDA CDRH C50418 Death/Expired Expired/death FDA C54450 Patient Problem Codes FDA CDRH C50472 Debris, Bone Shedding Shedding of accumulated bone fragments. Bone shedding debris|Shedding of bone debris FDA C54450 Patient Problem Codes FDA CDRH C50923 Decreased Apgar FDA C54450 Patient Problem Codes FDA CDRH C50774 Degeneration Deterioration; change from a higher to a lower form; especially change of tissue to a lower or less functionally active form. FDA C54450 Patient Problem Codes FDA CDRH C50527 Dehiscence FDA C54450 Patient Problem Codes FDA CDRH C26740 Dehydrated FDA C54450 Patient Problem Codes FDA CDRH C50433 Delamination FDA C54450 Patient Problem Codes FDA CDRH C4786 Dementia FDA C54450 Patient Problem Codes FDA CDRH C50531 Dementia, Dialysis A severe, often fatal encephalopathy which has been attributed to accumulation in the brain of aluminum from dialysate prepared with inadequately purified water. Dialysis dementia FDA C54450 Patient Problem Codes FDA CDRH C9442 Deposits FDA C54450 Patient Problem Codes FDA CDRH C2982 Depression FDA C54450 Patient Problem Codes FDA CDRH C26744 Dermatomyositis FDA C54450 Patient Problem Codes FDA CDRH C26874 Detached retina Retina, detached FDA C54450 Patient Problem Codes FDA CDRH C25751 Deterioration FDA C54450 Patient Problem Codes FDA CDRH C50530 Diabetic Ketoacidosis A type of metabolic acidosis produced by accumulation of ketone bodies resulting from uncontrolled diabetes mellitus. Ketoacidosis, diabetic FDA C54450 Patient Problem Codes FDA CDRH C50403 Diaphoretic Pertaining to or characterized by, or promoting diaphoresis; an agent that produces diaphoresis. (Diaphoresis is the act of perspiration, especially profuse perspiration). FDA C54450 Patient Problem Codes FDA CDRH C2987 Diarrhea FDA C54450 Patient Problem Codes FDA CDRH C50492 Difficulty Chewing FDA C54450 Patient Problem Codes FDA CDRH C21007 Disability FDA C54450 Patient Problem Codes FDA CDRH C50707 Disc Impingement FDA C54450 Patient Problem Codes FDA CDRH C50437 Discharge FDA C54450 Patient Problem Codes FDA CDRH C50535 Discomfort FDA C54450 Patient Problem Codes FDA CDRH C50536 Disfigurement FDA C54450 Patient Problem Codes FDA CDRH C61409 Dissection FDA C54450 Patient Problem Codes FDA CDRH C2992 Disseminated intravascular coagulation (DIC) A disorder characterized by reduction in the elements involved in blood coagulation due to their utilization in widespread blood clotting within the vessels. Coagulation (DIC), disseminated intravascular|Intravascular coagulation (DIC), disseminated|Disseminated intravascular coagulation|DIC, disseminated intravascular coagulation|DIC FDA C54450 Patient Problem Codes FDA CDRH C50537 Distention FDA C54450 Patient Problem Codes FDA CDRH C37942 Distress FDA C54450 Patient Problem Codes FDA CDRH C37943 Dizziness FDA C54450 Patient Problem Codes FDA CDRH C50434 Drainage FDA C54450 Patient Problem Codes FDA CDRH C34553 Dry Eye(s) Eye(s), dry FDA C54450 Patient Problem Codes FDA CDRH C50539 Dyskinesia Difficulty moving; distortion or impairment of voluntary movement, as in tic, spasm, or myoclonus. FDA C54450 Patient Problem Codes FDA CDRH C2980 Dysphagia FDA C54450 Patient Problem Codes FDA CDRH C35546 Dysphasia FDA C54450 Patient Problem Codes FDA CDRH C2998 Dyspnea Breathing Difficulties|Difficulty breathing FDA C54450 Patient Problem Codes FDA CDRH C2999 Dysuria Difficulty or pain in urination. FDA C54450 Patient Problem Codes FDA CDRH C26758 Ecchymosis FDA C54450 Patient Problem Codes FDA CDRH C34945 Ectopic Pregnancy Pregnancy, ectopic FDA C54450 Patient Problem Codes FDA CDRH C3002 Edema FDA C54450 Patient Problem Codes FDA CDRH C35468 Edema, macular Macular edema FDA C54450 Patient Problem Codes FDA CDRH C50901 Edema, Microcytic Microcytic edema FDA C54450 Patient Problem Codes FDA CDRH C50859 Edema, Stromal Fluid from the aqueous humor enters the corneal stroma and causes swelling. Stromal edema FDA C54450 Patient Problem Codes FDA CDRH C50543 EKG/ECG Changes Changes in cardiac electrical activity. Changes in EKG/ECG|ECG/EKG changes FDA C54450 Patient Problem Codes FDA CDRH C50541 Electric Shock Shock, electric|Shock, Electrical|Electrical Shock FDA C54450 Patient Problem Codes FDA CDRH C50544 Electrocution The passage of electrical current through the body. FDA C54450 Patient Problem Codes FDA CDRH C50545 Electrolyte Imbalance Higher or lower than normal values for the serum electrolytes; usually affecting NA, K, CHL, CO2, glucose, bun. Imbalance, electrolyte FDA C54450 Patient Problem Codes FDA CDRH C50542 Electro-Mechanical Dissociation Continued electrical rhythmicity of the heart in the absence of effective mechanical function. Dissociation, electro-mechanical FDA C54450 Patient Problem Codes FDA CDRH C26759 Embolism FDA C54450 Patient Problem Codes FDA CDRH C50547 Embolus A mass of clotted blood or other formed elements, such as bubbles of air, calcium fragments, etc. brought by the blood from another vessel and forced into a smaller one, thus obstructing the circulation. FDA C54450 Patient Problem Codes FDA CDRH C50489 Emotional Changes Changes, emotional FDA C54450 Patient Problem Codes FDA CDRH C3348 Emphysema, Pulmonary A condition of the lung characterized by increase beyond normal in the size of air spaces distal to the terminal bronchioles, either from dilatation of the alveoli or from destruction of their walls. Pulmonary emphysema FDA C54450 Patient Problem Codes FDA CDRH C26760 Encephalitis FDA C54450 Patient Problem Codes FDA CDRH C26920 Encephalopathy FDA C54450 Patient Problem Codes FDA CDRH C34582 Endocarditis FDA C54450 Patient Problem Codes FDA CDRH C34586 Endophthalmitis FDA C54450 Patient Problem Codes FDA CDRH C50918 Endotoxin FDA C54450 Patient Problem Codes FDA CDRH C50548 Entrapment Patient becomes entangled or caught in a bed, particularly in side rails, or mattress, or head/foot boards. FDA C54450 Patient Problem Codes FDA CDRH C50480 Enzyme Elevation, Cardiac Cardiac enzyme elevation|Elevation of cardiac enzymes FDA C54450 Patient Problem Codes FDA CDRH C50829 Epithelial Marsupialization Marsupialization, epithelial FDA C54450 Patient Problem Codes FDA CDRH C50443 Erosion An eating away or breakdown of any type of external or internal human tissue including but not limited to skin, teeth, mucosa, or somatic, which involves only the outer tissue layer. When tissue surrounds an implanted device, the tissue breakdown may result in migration and loss of the implant material and may result in further complications such as infection or abscess. FDA C54450 Patient Problem Codes FDA CDRH C50550 Eructate To belch, the casting of upwind from the stomach. FDA C54450 Patient Problem Codes FDA CDRH C26901 Erythema FDA C54450 Patient Problem Codes FDA CDRH C50841 Esophagus, Laceration(s) Of Laceration(s) of esophagus FDA C54450 Patient Problem Codes FDA CDRH C50693 Esophagus, Perforation Of Perforation of esophagus FDA C54450 Patient Problem Codes FDA CDRH C50553 Exit Block FDA C54450 Patient Problem Codes FDA CDRH C50554 Expulsion FDA C54450 Patient Problem Codes FDA CDRH C50856 Exsanguination Extensive loss of blood due to internal or external hemorrhage. FDA C54450 Patient Problem Codes FDA CDRH C48198 Extravasation A discharge or escape, as of blood, from a vessel into the tissues. FDA C54450 Patient Problem Codes FDA CDRH C50556 Extreme Exhaustion Extreme fatigue; inability to respond to stimuli. Exhaustion, extreme FDA C54450 Patient Problem Codes FDA CDRH C50557 Extrusion Thrusting or pushing out; expulsion by force. FDA C54450 Patient Problem Codes FDA CDRH C50819 Extubate FDA C54450 Patient Problem Codes FDA CDRH C34602 Eye injury Injury, eye FDA C54450 Patient Problem Codes FDA CDRH C26769 Facial Nerve Paralysis Paralysis of facial nerve|Nerve paralysis, facial FDA C54450 Patient Problem Codes FDA CDRH C50857 Fainting Extremely weak; threatened with syncope. FDA C54450 Patient Problem Codes FDA CDRH C50558 Fall FDA C54450 Patient Problem Codes FDA CDRH C50559 Fasciitis Inflammation of fascia. FDA C54450 Patient Problem Codes FDA CDRH C3036 Fatigue FDA C54450 Patient Problem Codes FDA CDRH C50560 Feeding Problems Problems, feeding FDA C54450 Patient Problem Codes FDA CDRH C50562 Fetal Brain Injury Injury occurring as a result of the delivery process. Brain injury, fetal|Injury, fetal brain FDA C54450 Patient Problem Codes FDA CDRH C50546 Fetal Core Temperature Rise Elevation of total fetal body temperature. Core temperature rise, fetal|Temperature rise, fetal core|Rise in fetal core temperature FDA C54450 Patient Problem Codes FDA CDRH C50563 Fetal Distress Distress, fetal FDA C54450 Patient Problem Codes FDA CDRH C51370 Fetal scalp laceration(s) Laceration(s), fetal scalp|Scalp laceration(s), fetal FDA C54450 Patient Problem Codes FDA CDRH C3038 Fever FDA C54450 Patient Problem Codes FDA CDRH C50566 Fibromyitis Inflammation and fibrous degeneration of a muscle. FDA C54450 Patient Problem Codes FDA CDRH C3044 Fibrosis The formation of fibrous tissue; fibroid or fibrous degeneration. FDA C54450 Patient Problem Codes FDA CDRH C50532 First Use Syndrome A symptom complex characterized by nervousness, chest pain, back pain, palpations, pruritus, and other usually mild symptoms occurring minutes following the initiation of dialysis with a new dialyzer. Syndrome, first use FDA C54450 Patient Problem Codes FDA CDRH C3045 Fistula FDA C54450 Patient Problem Codes FDA CDRH C50568 Flashers A sudden or brief burst of light. FDA C54450 Patient Problem Codes FDA CDRH C50569 Flatus Gas or air in the gastrointestinal tract. FDA C54450 Patient Problem Codes FDA CDRH C50570 Follow-Up Bowel Resection Required FDA C54450 Patient Problem Codes FDA CDRH C50524 Forced Expiratory Volume, Decreased A decrease in the fraction of the forced vital capacity that is exhaled in a specific number of seconds. FEV decreased|FEV (forced expiratory volume), decreased|Decreased forced expiratory volume (FEV)|Volume (FEV), decreased forced expiratory|Forced expiratory volume (FEV), decreased FDA C54450 Patient Problem Codes FDA CDRH C50609 Forced Expiratory Volume, Increased An increase in the fraction of the forced vital capacity that is exhaled in a specific number of seconds. FEV increased|FEV, (forced expiratory volume), increased|Forced expiratory volume (FEV), increased|Increased forced expiratory volume (FEV)|Volume (FEV), increased forced expiratory FDA C54450 Patient Problem Codes FDA CDRH C50444 Foreign Body Reaction A granulomatous inflammatory reaction evoked by the presence of an exogenous material in the tissues, a characteristic feature of which is the formation of foreign body giant cells. Reaction, foreign body FDA C54450 Patient Problem Codes FDA CDRH C50572 Foreign Body Sensation Feeling of grittiness or having something in the eye; frequently caused by a foreign body. Other possible causes include corneal abrasion, corneal ulcer, inturned eye lash or acute conjunctivitis. Sensation, foreign body FDA C54450 Patient Problem Codes FDA CDRH C50821 Foreign Body, Removal Of Removal of foreign body FDA C54450 Patient Problem Codes FDA CDRH C3046 Fracture(s) FDA C54450 Patient Problem Codes FDA CDRH C27783 Fracture, Arm FDA C54450 Patient Problem Codes FDA CDRH C50529 Fracture, Delayed Union Delayed union fracture|Union fracture, delayed FDA C54450 Patient Problem Codes FDA CDRH C26794 Fracture, Hip Hip fracture FDA C54450 Patient Problem Codes FDA CDRH C50745 Fracture, Skull Skull fracturel FDA C54450 Patient Problem Codes FDA CDRH C50777 Fracture, Tooth Tooth fracture FDA C54450 Patient Problem Codes FDA CDRH C14209 Fungus FDA C54450 Patient Problem Codes FDA CDRH C50573 Gangrene Death of tissue, usually in considerable mass and generally associated with loss of vascular (nutritive) supply and followed by bacterial invasion and putrefaction. FDA C54450 Patient Problem Codes FDA CDRH C26780 Gastritis FDA C54450 Patient Problem Codes FDA CDRH C26782 Glaucoma FDA C54450 Patient Problem Codes FDA CDRH C3064 Granuloma FDA C54450 Patient Problem Codes FDA CDRH C52352 Great Vessel Perforation Perforation, great vessel FDA C54450 Patient Problem Codes FDA CDRH C50575 Hair Loss Loss of hair FDA C54450 Patient Problem Codes FDA CDRH C50806 Halo Hazy ring around bright lights seen by some patients with refractive error or optical defects, e.g. cataracts, or corneal swelling. FDA C54450 Patient Problem Codes FDA CDRH C50509 Haze FDA C54450 Patient Problem Codes FDA CDRH C34660 Head Injury Injury, head FDA C54450 Patient Problem Codes FDA CDRH C34661 Headache FDA C54450 Patient Problem Codes FDA CDRH C50643 Headache, Lumbar Puncture Headache in erect position, after lumbar puncture; due to lowering of intracranial pressure by leakage of cerebrospinal fluid through the needle tract. Post spinal headache|Headache, post spinal|Lumbar puncture headache FDA C54450 Patient Problem Codes FDA CDRH C50601 Healing, Impaired Impaired healing FDA C54450 Patient Problem Codes FDA CDRH C50576 Hearing Impairment Impairment, hearing FDA C54450 Patient Problem Codes FDA CDRH C35731 Hearing loss Loss of hearing FDA C54450 Patient Problem Codes FDA CDRH C50577 Heart Failure Inability of the heart to pump blood at an adequate rate to fill tissue metabolic requirements or the ability to do so only at an elevated filling pressure. Cardiac Insufficiency|Failure, Heart|Insufficiency, cardiac FDA C54450 Patient Problem Codes FDA CDRH C50818 Heart Valve Repair Valve, repair of heart|Repair, heart valve FDA C54450 Patient Problem Codes FDA CDRH C34670 Heartburn FDA C54450 Patient Problem Codes FDA CDRH C50578 Heavier Menses FDA C54450 Patient Problem Codes FDA CDRH C50579 Hematoma A localized collection of blood, usually clotted, in an organ, space, or tissue, due to a break in the wall of a blood vessel. FDA C54450 Patient Problem Codes FDA CDRH C3090 Hematuria FDA C54450 Patient Problem Codes FDA CDRH C50580 Hemoconcentration An increase in the concentration of blood cells resulting from the loss of plasma or water from the blood stream. FDA C54450 Patient Problem Codes FDA CDRH C15248 Hemodialysis FDA C54450 Patient Problem Codes FDA CDRH C37965 Hemolysis FDA C54450 Patient Problem Codes FDA CDRH C34376 Hemolytic Anemia Anemia, hemolytic FDA C54450 Patient Problem Codes FDA CDRH C3094 Hemoptysis FDA C54450 Patient Problem Codes FDA CDRH C26791 Hemorrhage Bleeding FDA C54450 Patient Problem Codes FDA CDRH C50485 Hemorrhage, cerebral Hemorrhage into the cerebrum. See also Stroke Syndrome. Bleeding, cerebral|Cerebral bleeding|Cerebral hemorrhage FDA C54450 Patient Problem Codes FDA CDRH C50555 Hemorrhage, Extradural Intracranial hemorrhage into the epidural space. Extradural hemorrhage FDA C54450 Patient Problem Codes FDA CDRH C50896 Hemorrhage, Intraventricular Intraventricular hemorrhage FDA C54450 Patient Problem Codes FDA CDRH C50757 Hemorrhage, Subarachnoid Intracranial hemorrhage into the subarachnoid space. Subarachnoid hemorrhage FDA C54450 Patient Problem Codes FDA CDRH C50759 Hemorrhage, Subdural Cerebral hemorrhage into the subdural space. See also Stroke Syndrome. Subdural hemorrhage FDA C54450 Patient Problem Codes FDA CDRH C50761 Hemorrhage, Subgaleal Hemorrhage, subgaleal FDA C54450 Patient Problem Codes FDA CDRH C50581 Hemostasis The arrest of bleeding, either by the physiological properties of vasoconstriction and coagulation or by surgical means. FDA C54450 Patient Problem Codes FDA CDRH C50582 Hemothorax A collection of blood in the pleural cavity. FDA C54450 Patient Problem Codes FDA CDRH C3095 Hepatitis FDA C54450 Patient Problem Codes FDA CDRH C34685 Hernia FDA C54450 Patient Problem Codes FDA CDRH C50583 Herpes Any inflammatory skin disease caused by a herpesvirus and characterized by the formation of small vesicles in clusters. FDA C54450 Patient Problem Codes FDA CDRH C37966 Hiccups FDA C54450 Patient Problem Codes FDA CDRH C14219 HIV, Human Immunodeficiency Virus A cytopathic retrovirus. It is the etiological agent of AIDS. Human immunodeficiency virus (HIV)|Virus (HIV), human immunodeficiency FDA C54450 Patient Problem Codes FDA CDRH C50414 Hospitalization Required Required hospitalization FDA C54450 Patient Problem Codes FDA CDRH C50586 Host-Tissue Reaction Growth of tissue in or around a foreign body as the body's antibody response to the foreign body. Tissue, reaction of host|Reaction of host-tissue FDA C54450 Patient Problem Codes FDA CDRH C3109 Hot Flashes Flashes, hot FDA C54450 Patient Problem Codes FDA CDRH C50736 Hyaloid Face, Rupture Of Face, rupture of hyaloid|Rupture of hyaloid face FDA C54450 Patient Problem Codes FDA CDRH C27088 Hyperbilirubinemia Excessive concentrations of bilirubin in the blood, which may lead to jaundice. FDA C54450 Patient Problem Codes FDA CDRH C50588 Hyperemia The presence of an increased amount of blood in a part or organ; engorgement. FDA C54450 Patient Problem Codes FDA CDRH C26797 Hyperglycemia Blood Glucose, High|Glucose, high blood|High blood glucose FDA C54450 Patient Problem Codes FDA CDRH C37970 Hypernatremia FDA C54450 Patient Problem Codes FDA CDRH C3113 Hyperplasia FDA C54450 Patient Problem Codes FDA CDRH C3114 Hypersensitivity Hypersensitivity; a local or general reaction of an organism following contact with a specific allergen to which it has been previously exposed and to which it has become sensitized. Allergic Reaction FDA C54450 Patient Problem Codes FDA CDRH C3117 Hypertension Blood Pressure, High|High blood pressure|Blood Pressure, Increased|Increased blood pressure|Pressure, high blood FDA C54450 Patient Problem Codes FDA CDRH C50589 Hyperthermia FDA C54450 Patient Problem Codes FDA CDRH C50590 Hyperventilation Abnormally prolonged, rapid, and deep breathing. FDA C54450 Patient Problem Codes FDA CDRH C50591 Hypervolemia FDA C54450 Patient Problem Codes FDA CDRH C50592 Hyphema Hemorrhage within the anterior chamber of the eye; bloodshot. FDA C54450 Patient Problem Codes FDA CDRH C50445 Hypoesthesia Consisting of abnormally decreased sensitivity, particularly to touch. FDA C54450 Patient Problem Codes FDA CDRH C50463 Hypoesthesia, Arm/Hand Consisting of abnormally decreased sensitivity, particularly to touch. FDA C54450 Patient Problem Codes FDA CDRH C50571 Hypoesthesia, Foot/Leg Consisting of abnormally decreased sensitivity, particularly to touch. Leg/foot hypoesthesia|Foot/leg hypoesthesia FDA C54450 Patient Problem Codes FDA CDRH C3126 Hypoglycemia Blood Glucose, Low|Glucose, low blood|Low blood glucose FDA C54450 Patient Problem Codes FDA CDRH C50593 Hypopyon An accumulation of pus in the anterior chamber of the eye. FDA C54450 Patient Problem Codes FDA CDRH C3128 Hypotension Blood Pressure, Decreased|Blood Pressure, Low|Decreased blood pressure|Low blood pressure|Pressure, low blood FDA C54450 Patient Problem Codes FDA CDRH C50523 Hypothermia Abnormally low body temperature. Body temperature, decreased|Decreased body temperature|Temperature, decreased body FDA C54450 Patient Problem Codes FDA CDRH C50594 Hypoventilation A state in which there is a reduced amount of air entering the pulmonary alveoli. FDA C54450 Patient Problem Codes FDA CDRH C50595 Hypovolemia Abnormally decreased volume of circulating fluid (plasma) in body. FDA C54450 Patient Problem Codes FDA CDRH C3890 Hypoxia FDA C54450 Patient Problem Codes FDA CDRH C50564 Hypoxia, Fetal Hypoxia in utero, caused by conditions such as inadequate placental function (often abruptio placentae), preeclamptic toxicity, prolapse of the umbilical cord, or complications from anesthetic administration. FDA C54450 Patient Problem Codes FDA CDRH C50597 Iatrogenic Lesion Denoting any adverse condition in a patient occurring as the result of treatment by a physician or surgeon, especially infections acquired by the patient during the course of the treatment. Lesion, iatrogenic FDA C54450 Patient Problem Codes FDA CDRH C50598 Iatrogenic Source Source, iatogenic FDA C54450 Patient Problem Codes FDA CDRH C50839 Identified Diagnosis Diagnosis, identified FDA C54450 Patient Problem Codes FDA CDRH C50599 Idioventricular Rhythm Relating to or affecting the cardiac ventricles alone. Rhythm, idioventricular FDA C54450 Patient Problem Codes FDA CDRH C50626 Immobility Of The Joint FDA C54450 Patient Problem Codes FDA CDRH C3131 Immuno-Deficiency A deficiency of immune response or a disorder characterized by deficient immune response. FDA C54450 Patient Problem Codes FDA CDRH C50603 Implant, Failure Of An object or material, such as an alloplastic or radioactive material or tissue, partially or totally inserted or grafted into the body for prosthetic, therapeutic, diagnostic, or experimental purposes. Failure of implant FDA C54450 Patient Problem Codes FDA CDRH C3133 Impotence FDA C54450 Patient Problem Codes FDA CDRH C50415 Improved Patient Condition Condition of patient, improved|Patient condition, improved FDA C54450 Patient Problem Codes FDA CDRH C50914 Inadequate Osteointegration FDA C54450 Patient Problem Codes FDA CDRH C50607 Incompetent Cervix One that is abnormally prone to dilate in the second trimester of pregnancy, resulting in premature expulsion of the fetus. Cervix, incompetent FDA C54450 Patient Problem Codes FDA CDRH C3429 Incontinence FDA C54450 Patient Problem Codes FDA CDRH C50486 Infarction, cerebral An ischemic condition of the brain, producing a persistent focal neurological deficit in the area of distribution of the cerebral arteries. Cerebral, Infarction FDA C54450 Patient Problem Codes FDA CDRH C26726 Infection FDA C54450 Patient Problem Codes FDA CDRH C2890 Infection, Bacterial Bacterial infection FDA C54450 Patient Problem Codes FDA CDRH C50534 Infection, Direct Infection produced by direct contact with another person. Direct infection FDA C54450 Patient Problem Codes FDA CDRH C3245 Infection, Fungal Fungal infection FDA C54450 Patient Problem Codes FDA CDRH C50612 Infection, Indirect Infection transmitted by water, food or other means of conveyance. Indirect infection FDA C54450 Patient Problem Codes FDA CDRH C50617 Infection, Intraocular Infection within the eye. Intraocular infection FDA C54450 Patient Problem Codes FDA CDRH C50719 Infection, Pyrogenic An infection caused by pus-producing organisms. Pyrogenic infection FDA C54450 Patient Problem Codes FDA CDRH C50758 Infection, Subclinical Infection associated with no detectable symptoms but caused by microorganisms capable of producing easily recognizable diseases, such a poliomyelitis or mumps. Subclinical infection FDA C54450 Patient Problem Codes FDA CDRH C35650 Infection, Upper Respiratory Tract FDA C54450 Patient Problem Codes FDA CDRH C50791 Infection, Urinary Tract Urinary tract infection|Tract, infection of urinary FDA C54450 Patient Problem Codes FDA CDRH C3439 Infection, Viral Viral infection FDA C54450 Patient Problem Codes FDA CDRH C50922 Infective Agents Agents, infective FDA C54450 Patient Problem Codes FDA CDRH C25754 Infiltration To penetrate a tissue or substance. Infiltrates FDA C54450 Patient Problem Codes FDA CDRH C3137 Inflammation FDA C54450 Patient Problem Codes FDA CDRH C3671 Injury FDA C54450 Patient Problem Codes FDA CDRH C25182 Inpatient FDA C54450 Patient Problem Codes FDA CDRH C50796 Insufficiency, Valvular Dysfunction of one of the cardiac valves, with incomplete valve closure resulting in valvular regurgitation. Valvular insufficiency FDA C54450 Patient Problem Codes FDA CDRH C34818 Intermenstrual Bleeding FDA C54450 Patient Problem Codes FDA CDRH C50616 Intimal Dissection Pertaining to the inner layer of the blood vessels. Dissection, intimal FDA C54450 Patient Problem Codes FDA CDRH C50438 Intracranial hemorrhage Bleeding within the cranium. Bleeding, Intracranial|Intracranial bleeding|Hemorrhage, Intracranial FDA C54450 Patient Problem Codes FDA CDRH C50618 Intraocular Pressure Rise Increase of pressure of the intraocular fluid in the eye. IOPR|Rise in intraocular pressure, (IOPR)|Pressure (IOPR), rise in intraocular|IOPR, intraocular pressure rise|Intraocular pressure rise, (IOPR) FDA C54450 Patient Problem Codes FDA CDRH C50786 Intraocular Pressure, Delayed, Uncontrolled Changes in the fluid pressure inside the eye. Delayed, uncontrolled intraocular pressure (IOP)|IOP Delayed, Uncontrolled|IOP (intraocular pressure), delayed, uncontrolled|Pressure (IOP), delayed uncontrolled intraocular|Uncontrolled/delayed intraocular pressure (IOP)|Intraocular pressure (IOP), delayed, uncontrolled FDA C54450 Patient Problem Codes FDA CDRH C50619 Intraoperative Pain FDA C54450 Patient Problem Codes FDA CDRH C48197 Intravasation The entrance of foreign matter into a blood vessel. FDA C54450 Patient Problem Codes FDA CDRH C37981 Intubation FDA C54450 Patient Problem Codes FDA CDRH C50621 Iritis Inflammation of the iris. FDA C54450 Patient Problem Codes FDA CDRH C50623 Irritability FDA C54450 Patient Problem Codes FDA CDRH C50624 Irritation FDA C54450 Patient Problem Codes FDA CDRH C34738 Ischemia FDA C54450 Patient Problem Codes FDA CDRH C50625 Ischemic Heart Disease Disease, ischemic heart|Heart disease, ischemic FDA C54450 Patient Problem Codes FDA CDRH C3344 Itching FDA C54450 Patient Problem Codes FDA CDRH C3143 Jaundice FDA C54450 Patient Problem Codes FDA CDRH C26750 Joint Dislocation Dislocated joint FDA C54450 Patient Problem Codes FDA CDRH C35760 Joint Disorder Disorder, joint FDA C54450 Patient Problem Codes FDA CDRH C50627 Joint Swelling Swelling, joint FDA C54450 Patient Problem Codes FDA CDRH C26805 Keratitis FDA C54450 Patient Problem Codes FDA CDRH C50450 Keratitis, Acanthamoeba Keratitis due to infection by acanthamoeba; it is usually associated with soft contact lens wear, particularly overnight wear. Acanthamoeba keratitis FDA C54450 Patient Problem Codes FDA CDRH C50917 Labor, Premature Ouster of a viable infant before the normal end of gestation, commonly defined as interruption of pregnancy between the twentieth-thirty seventh completed weeks after the onset of the last menstrual cycle. Premature labor FDA C54450 Patient Problem Codes FDA CDRH C50446 Laceration(s) FDA C54450 Patient Problem Codes FDA CDRH C15266 Laparotomy FDA C54450 Patient Problem Codes FDA CDRH C61390 Lead(s), burn(s) from FDA C54450 Patient Problem Codes FDA CDRH C61392 Lead(s), shock from FDA C54450 Patient Problem Codes FDA CDRH C50628 Leaflet Disruption A separation of the cusp of a heart valve. Disruption, leaflet FDA C54450 Patient Problem Codes FDA CDRH C50864 Leaflet Disruption Due To Calcification Calicification, leaflet disruption due to FDA C54450 Patient Problem Codes FDA CDRH C50906 Leaflet Disruption Due To Host Tissue Overgrowth Host tissue overgrowth, leaflet disruption due to FDA C54450 Patient Problem Codes FDA CDRH C50866 Leaflet Disruption Due To Infection Infection, leaflet disruption due to FDA C54450 Patient Problem Codes FDA CDRH C50908 Leaflet Disruption Due To Suture Abrasion Suture abrasion, leaflet disruption due to FDA C54450 Patient Problem Codes FDA CDRH C50907 Leaflet Disruption, Cause Unknown Unknown cause of leaflet disruption FDA C54450 Patient Problem Codes FDA CDRH C50696 Leak(s), Perivalvular The escape of blood around a heart valve, particularly around its leaflets. Perivalvular Leak FDA C54450 Patient Problem Codes FDA CDRH C50629 Left Ventricular Dysfunction Dysfunction, left ventricular|Ventricular dysfunction, left FDA C54450 Patient Problem Codes FDA CDRH C50630 Left Ventricular Failure Failure of adequate output by the left ventricle despite an increase in distending pressure and in end-diastolic volume, with dyspnea, orthopnea, and other signs and symptoms of pulmonary congestion and edema. Failure, left ventricular|Ventricular failure, left FDA C54450 Patient Problem Codes FDA CDRH C50631 Left Ventricular Hypertrophy Enlargement or overgrowth of the myocardium of the left ventricle, due to chronic pressure overload. Ventricular hypertrophy, left FDA C54450 Patient Problem Codes FDA CDRH C50836 Lens, Replacement Of FDA C54450 Patient Problem Codes FDA CDRH C3824 Lesion FDA C54450 Patient Problem Codes FDA CDRH C50632 Lesions In The Target Points FDA C54450 Patient Problem Codes FDA CDRH C50412 Lethargic FDA C54450 Patient Problem Codes FDA CDRH C50633 Ligament(s), Damage To Damage to ligament(s) FDA C54450 Patient Problem Codes FDA CDRH C50909 Limited Mobility Of The Implanted Joint FDA C54450 Patient Problem Codes FDA CDRH C50853 Liver Contusion Bruising of the liver. Contusion, liver FDA C54450 Patient Problem Codes FDA CDRH C50634 Liver Dysfunction Dysfunction, liver FDA C54450 Patient Problem Codes FDA CDRH C50854 Liver Laceration(s) Laceration(s), liver FDA C54450 Patient Problem Codes FDA CDRH C50635 Loss of consciousness FDA C54450 Patient Problem Codes FDA CDRH C50636 Loss of pulse Pulse, Loss Of FDA C54450 Patient Problem Codes FDA CDRH C50641 Low Cardiac Output Cardiac output, low|Output, low cardiac FDA C54450 Patient Problem Codes FDA CDRH C50644 Lung, Overinflation Of Overinflation of lung FDA C54450 Patient Problem Codes FDA CDRH C27153 Lupus FDA C54450 Patient Problem Codes FDA CDRH C3832 Malaise FDA C54450 Patient Problem Codes FDA CDRH C50431 Mammogram, Abnormal Abnormal mammogram FDA C54450 Patient Problem Codes FDA CDRH C50413 Manual Ventilation Required Ventilation required, manual FDA C54450 Patient Problem Codes FDA CDRH C50645 Mediastinal Shift Normal location of the mediastinum changes to the right or left, depending upon the underlying cause. Shift, mediastinal FDA C54450 Patient Problem Codes FDA CDRH C54027 Medical Problem Patient Problem Code|Patient Problem FDA C54450 Patient Problem Codes FDA CDRH C50649 Membrane, Breakage Of Breakage of membrane FDA C54450 Patient Problem Codes FDA CDRH C2867 Memory Loss Loss of memorys FDA C54450 Patient Problem Codes FDA CDRH C26828 Meningitis FDA C54450 Patient Problem Codes FDA CDRH C35219 Menstrual Irregularities Deviations from the normal process; e.g. delayed, difficult, profuse, scanty, unusual bleeding, etc. Irregularities, menstrual FDA C54450 Patient Problem Codes FDA CDRH C41456 Microcyst(s) A tiny cyst, frequently of such dimensions that a magnifying lens or microscope is required for observation. FDA C54450 Patient Problem Codes FDA CDRH C50549 Microcysts, Epithelial Very small, round vesicles containing fluid and cellular debris observed on the surface of the cornea under slit-lamp examination in some types of corneal dystrophy and in wearers of extended-wear lenses. Epithelial microcysts FDA C54450 Patient Problem Codes FDA CDRH C50650 Microperforation(s) Small holes made through a part or a substance. FDA C54450 Patient Problem Codes FDA CDRH C50651 Migration Pass from one part of the body or organ to another. FDA C54450 Patient Problem Codes FDA CDRH C34336 Miscarriage Loss of the products of conception from the uterus before the fetus is viable; spontaneous abortion. FDA C54450 Patient Problem Codes FDA CDRH C50432 Misdiagnosis FDA C54450 Patient Problem Codes FDA CDRH C50429 Missed Dose Dose, missed FDA C54450 Patient Problem Codes FDA CDRH C50888 Mitral Insufficiency Insufficiency, mitral FDA C54450 Patient Problem Codes FDA CDRH C50653 Mitral Perforation Perforation, mitral FDA C54450 Patient Problem Codes FDA CDRH C50852 Mitral Regurgitation The backward flow of blood from the left ventricle into the left atrium, owing to insufficiency of the mitral valve; it may be acute or chronic, usually due to mitral valve prolapse, rheumatic heart disease or a complication of cardiac dilatation. Regurgitation, mitral FDA C54450 Patient Problem Codes FDA CDRH C50654 Mitral Stenosis Narrowing of the left atrioventricular mitral orifice. Stenosis, mitral FDA C54450 Patient Problem Codes FDA CDRH C50655 Mitral Valve Prolapse Prolapse of the mitral valve, often with regurgitation, associated with myxomatous proliferation of the leaflets of the mitral valve. Valve, prolapse of mitral|Prolapse, mitral valve FDA C54450 Patient Problem Codes FDA CDRH C50825 Mitral Valve Replacement Valve replacement, mitral|Replacement, mitral valve FDA C54450 Patient Problem Codes FDA CDRH C50656 Muscle Spasm(s) A sudden, violent, involuntary contraction of a muscle or group of muscles. Spasm(s), muscle) FDA C54450 Patient Problem Codes FDA CDRH C50657 Muscle Stimulation Stimulation of muscle FDA C54450 Patient Problem Codes FDA CDRH C50658 Muscle Weakness Weakness, muscular FDA C54450 Patient Problem Codes FDA CDRH C50659 Muscular Rigidity Stiffness or inflexibility. Rigidity, muscular FDA C54450 Patient Problem Codes FDA CDRH C50660 Muscular Tics An involuntary, compulsive, repetitive stereotyped movement, usually of the face or shoulders. FDA C54450 Patient Problem Codes FDA CDRH C27009 Myalgia FDA C54450 Patient Problem Codes FDA CDRH C50661 Myocardial Contusion A bruise to the heart. Cardiac contusion|Contusion, cardiac|Contusion, myocardial FDA C54450 Patient Problem Codes FDA CDRH C27996 Myocardial Infarction Gross necrosis of the myocardium, as a result of interruption of the blood supply to the area, as in coronary thrombosis. Infarction (MI), myocardial|MI|Myocardial infarction, (MI)l|MI, myocardial infarctionl FDA C54450 Patient Problem Codes FDA CDRH C34831 Myocarditis FDA C54450 Patient Problem Codes FDA CDRH C50662 Nasal Obstruction Obstruction, nasal FDA C54450 Patient Problem Codes FDA CDRH C3258 Nausea FDA C54450 Patient Problem Codes FDA CDRH C16897 Necrosis FDA C54450 Patient Problem Codes FDA CDRH C50567 Necrosis Of Flap Tissue Flap tissue, necrosis of|Tissue, necrosis of flap FDA C54450 Patient Problem Codes FDA CDRH C50665 Needle Stick/Puncture Stick/puncture from needle|Puncture/stick from needle FDA C54450 Patient Problem Codes FDA CDRH C50666 Neonatal Deformities Deformities, neonatal FDA C54450 Patient Problem Codes FDA CDRH C50667 Neonatal Hearing Impairment Hearing impairment, neonatal|Impairment to hearing, neonatal FDA C54450 Patient Problem Codes FDA CDRH C50668 Neonatal Hearing Loss Hearing loss, neonatal|Loss of hearing, neonatal FDA C54450 Patient Problem Codes FDA CDRH C16900 Neovascularization FDA C54450 Patient Problem Codes FDA CDRH C50669 Nerve Damage Damage to nerve(s) FDA C54450 Patient Problem Codes FDA CDRH C50915 Nerve Proximity NOS (Not Otherwise Specified) FDA C54450 Patient Problem Codes FDA CDRH C50787 Nerve Stimulation, Undesired Stimulation of nerve, undesired|Undesired nerve stimulation FDA C54450 Patient Problem Codes FDA CDRH C50670 Neural Tissue Damage Damage to neural tissue|Tissue damage, neural FDA C54450 Patient Problem Codes FDA CDRH C50672 Neurological Deficit/Dysfunction Deficit/dysfunction, neurological|Dysfunction/deficit, neurological FDA C54450 Patient Problem Codes FDA CDRH C4731 Neuropathy FDA C54450 Patient Problem Codes FDA CDRH C50673 Nipple Sensation, Changes In/Loss Of Changes in/loss of nipple sensation|Loss of/changes in nipple sensation|Sensation, changes in/loss of nipple FDA C54450 Patient Problem Codes FDA CDRH C50674 Nipple Ulceration Ulceration, nipple FDA C54450 Patient Problem Codes FDA CDRH C50675 No Consequences Or Impact To Patient Consequences or impact to patient, none|Impact or consequences to patient, none|Patient, no consequences or impact to FDA C54450 Patient Problem Codes FDA CDRH C50912 No Patient Involvement FDA C54450 Patient Problem Codes FDA CDRH C50405 Nonpyrogenic FDA C54450 Patient Problem Codes FDA CDRH C50676 Nonresorbable Materials, Unretrieved In Body Materials (nonresorbable), unretrieved in body|Unretrieved nonresorbable materials in body FDA C54450 Patient Problem Codes FDA CDRH C50404 Nonspecific FDA C54450 Patient Problem Codes FDA CDRH C34857 Numbness FDA C54450 Patient Problem Codes FDA CDRH C3284 Obstruction FDA C54450 Patient Problem Codes FDA CDRH C50678 Occlusion The act of closure or the state of being closed; an obstruction; the relationship between all of the components of the masticatory system in normal function, dysfunction, and parafunction; momentary complete closure of some area in the vocal tract, causing stoppage of the breath and accumulation of pressure. FDA C54450 Patient Problem Codes FDA CDRH C50849 Optical Nerve Damage Damage to optical nerve(s)|Nerve damage, optical FDA C54450 Patient Problem Codes FDA CDRH C50475 Optical tissue, breakdown of Tissue, Breakdown Of Optical FDA C54450 Patient Problem Codes FDA CDRH C50679 Organ(s), Perforation Of Perforation of organ(s) FDA C54450 Patient Problem Codes FDA CDRH C50680 Ossification The formation of bone or of a bony substance; the conversion of fibrous tissue or of cartilage into bone or a bony substance. FDA C54450 Patient Problem Codes FDA CDRH C50681 Osteolysis Dissolution of bone; applied especially to the removal or loss of the calcium of bone. FDA C54450 Patient Problem Codes FDA CDRH C50910 Osteopenia Bone Loss FDA C54450 Patient Problem Codes FDA CDRH C28293 Outpatient FDA C54450 Patient Problem Codes FDA CDRH C50682 Overcorrection FDA C54450 Patient Problem Codes FDA CDRH C50873 Overdose FDA C54450 Patient Problem Codes FDA CDRH C50850 Oversedated FDA C54450 Patient Problem Codes FDA CDRH C50683 Overstimulation FDA C54450 Patient Problem Codes FDA CDRH C50504 Overwear Syndrome Ocular pain which may be very intense, accompanied by corneal epithelium damage, conjunctival injection, lacrimation, blepharospasm, photophobia and hazy vision following corneal edema caused by overwear of contact lenses, principally the PMMA type. Syndrome, overwear FDA C54450 Patient Problem Codes FDA CDRH C50584 Oxygen Saturation, High The calculated measurements indicating the degree to which oxygen is bound to hemoglobin is high. Saturation, high oxygen|High oxygen saturation FDA C54450 Patient Problem Codes FDA CDRH C50640 Oxygen Saturation, Low The calculated measurements indicating the degree to which oxygen is bound to hemoglobin is low. Saturation, low oxygen|Low oxygen saturation FDA C54450 Patient Problem Codes FDA CDRH C3303 Pain FDA C54450 Patient Problem Codes FDA CDRH C50605 Pain Relief, Inadequate Inadequate pain relief FDA C54450 Patient Problem Codes FDA CDRH C26682 Pain, Abdominal Abdominal pain FDA C54450 Patient Problem Codes FDA CDRH C50663 Pain, Neck Neck pain FDA C54450 Patient Problem Codes FDA CDRH C50684 Painful Stimulation Stimulation, painful FDA C54450 Patient Problem Codes FDA CDRH C50685 Pallor FDA C54450 Patient Problem Codes FDA CDRH C37999 Palpitations FDA C54450 Patient Problem Codes FDA CDRH C50686 Pannus Formation Superficial vascularization of the cornea with infiltration of granulation tissue; an inflammatory exudate overlying the lining layer of synovial cells on the inside of a joint. Formation, pannus FDA C54450 Patient Problem Codes FDA CDRH C3310 Paralysis FDA C54450 Patient Problem Codes FDA CDRH C50687 Paraplegia Paralysis of the legs and lower part of the body. FDA C54450 Patient Problem Codes FDA CDRH C50688 Paresis A slight or incomplete paralysis. FDA C54450 Patient Problem Codes FDA CDRH C61389 Patch test, abnormal results of FDA C54450 Patient Problem Codes FDA CDRH C50525 Peak Expiratory Flowrate, Decreased A decrease of the greatest rate of flow that can be achieved during forced expiration beginning with the lungs fully inflated. Flowrate, decreased peak expiratory|Decreased peak expiratory flowrate FDA C54450 Patient Problem Codes FDA CDRH C50610 Peak Expiratory Flowrate, Increased An increase of the greatest rate of flow that can be achieved during forced expiration beginning with the lungs fully inflated. Flowrate, increased peak expiratory|Increased peak expiratory flowrate FDA C54450 Patient Problem Codes FDA CDRH C50691 Peeling A peeling off or loss of epidermis, as in sunburn, postscarlatinal peeling, or toxic epidermal necrolysis. FDA C54450 Patient Problem Codes FDA CDRH C3889 Pelvic Inflammatory Disease Any pelvic infection involving the upper female genital tract beyond the cervix. Disease (PID), pelvic inflammatory|Inflammatory disease (PID), pelvic|PID|PID, pelvic inflammatory diseasec|Pelvic inflammatory disease, (PID) FDA C54450 Patient Problem Codes FDA CDRH C4080 Perforation FDA C54450 Patient Problem Codes FDA CDRH C50694 Peripheral Vascular Disease Disease, peripheral vascular|Vascular disease, peripheral FDA C54450 Patient Problem Codes FDA CDRH C50695 Peritoneal Laceration(s) Laceration(s), peritoneal FDA C54450 Patient Problem Codes FDA CDRH C26849 Peritonitis FDA C54450 Patient Problem Codes FDA CDRH C27061 Peroneal Nerve Palsy Paralysis of the nerves located in the legs. Nerve palsy, peroneal|Palsy, peroneal nerve FDA C54450 Patient Problem Codes FDA CDRH C26851 Pharyngitis FDA C54450 Patient Problem Codes FDA CDRH C38003 Phlebitis FDA C54450 Patient Problem Codes FDA CDRH C50697 Phosphene Visualization An objective visual sensation that appears with the eyes closed and in the absence of visual light. Visualization, phosphene FDA C54450 Patient Problem Codes FDA CDRH C50698 Phototoxicity A nonimmunologic, chemically induced type of photosensitivity. FDA C54450 Patient Problem Codes FDA CDRH C17000 Pleomorphism FDA C54450 Patient Problem Codes FDA CDRH C3331 Pleural Effusion Effusion, pleural FDA C54450 Patient Problem Codes FDA CDRH C3333 Pneumonia FDA C54450 Patient Problem Codes FDA CDRH C38006 Pneumothorax FDA C54450 Patient Problem Codes FDA CDRH C50699 Pocket Erosion Erosion of patient's skin pocket which houses a device. Erosion, pocket FDA C54450 Patient Problem Codes FDA CDRH C50700 Polydipsia Chronic excessive intake of water; it may be from an organic cause, such as the dehydration of diabetes mellitus, diabetes insipidus, or a reaction to medication, or from a psychological cause. When untreated it can lead to water intoxication. FDA C54450 Patient Problem Codes FDA CDRH C26925 Polymyositis FDA C54450 Patient Problem Codes FDA CDRH C50701 Positive antinuclear antibodies (ANA) Antibodies directed against nuclear antigens; almost invariably found in systemic lupus erythematosus and are frequently found in rheumatoid arthritis, scleroderma, Sjogren's Syndrome and mixed connective tissue disease. ANA, positive antinuclear antibodies|Antibodies (ANA), positive antinuclear|Antinuclear antibodies (ANA), positive FDA C54450 Patient Problem Codes FDA CDRH C50788 Postoperative Refraction, Unexpected FDA C54450 Patient Problem Codes FDA CDRH C50706 Pressure Sores/Ulcers Death of tissue due to external pressure. Ulcers/sores, pressure|Sores/ulcers, pressure|Pressure, necrosis|Necrosis, Pressure FDA C54450 Patient Problem Codes FDA CDRH C36173 Prolapse FDA C54450 Patient Problem Codes FDA CDRH C50710 Protrusion FDA C54450 Patient Problem Codes FDA CDRH C50711 Pseudoaneurysm FDA C54450 Patient Problem Codes FDA CDRH C27298 Ptosis FDA C54450 Patient Problem Codes FDA CDRH C50585 Pulmonary Arterial Wedge Pressure, High The measurement of the mean left arterial pressure, as measured by a catheter introduced into the distal pulmonary artery, is high. Arterial wedge pressure, high pulmonary|Pressure, high pulmonary arterial wedge|Wedge pressure, high pulmonary arterial|High pulmonary arterial wedge pressure FDA C54450 Patient Problem Codes FDA CDRH C50642 Pulmonary Arterial Wedge Pressure, Low The measurement of the mean left pulmonary arterial pressure, as measured by a catheter introduced into the distal pulmonary artery, is low. Arterial wedge pressure, low pulmonary|Wedge pressure, low pulmonary arterial|Low pulmonary arterial wedge pressure|Pressure, low pulmonary arterial wedge FDA C54450 Patient Problem Codes FDA CDRH C50677 Pulmonary Arterial Wedge Pressure, Normal The measurement of the mean left arterial pressure, as measured by a catheter introduced into the distal pulmonary artery, is normal. Arterial wedge pressure, normal pulmonary|Pressure, normal pulmonary arterial wedge|Normal pulmonary arterial wedge pressure|Wedge pressure, normal pulmonary arterial FDA C54450 Patient Problem Codes FDA CDRH C50712 Pulmonary Dysfunction Dysfunction, pulmonary FDA C54450 Patient Problem Codes FDA CDRH C26868 Pulmonary Edema Edema, pulmonary FDA C54450 Patient Problem Codes FDA CDRH C50713 Pulmonary Embolism The closure of the pulmonary artery or one of its branches by an embolus, sometimes associated with infarction of the lung. Embolism, pulmonary FDA C54450 Patient Problem Codes FDA CDRH C50714 Pulmonary Infarction Localized necrosis of lung tissue caused by obstruction of the arterial blood supply, most often due to pulmonary embolism. Infarction, pulmonary FDA C54450 Patient Problem Codes FDA CDRH C51447 Pulmonary Insufficiency Insufficiency, pulmonary FDA C54450 Patient Problem Codes FDA CDRH C50848 Pulmonary Regurgitation The backflow of blood from the pulmonary artery into the right ventricle, owing to insufficiency of the pulmonic semilunar valve. Regurgitation, pulmonary FDA C54450 Patient Problem Codes FDA CDRH C50715 Pulmonary Stenosis Narrowing of the opening between the pulmonary artery and the right ventricle, usually at the level of the valve leaflets. Stenosis, pulmonary FDA C54450 Patient Problem Codes FDA CDRH C50817 Pulmonary Valve Replacement Valve, replacement of pulmonary|Replacement of pulmonary valve FDA C54450 Patient Problem Codes FDA CDRH C50533 Pulse, Diminished Pulse, diminished FDA C54450 Patient Problem Codes FDA CDRH C50622 Pulse, Irregular A pulse that beats at irregular intervals. Irregular pulse FDA C54450 Patient Problem Codes FDA CDRH C51226 Punctured blood vessels Blood vessels, punctured|Vessels, punctured blood FDA C54450 Patient Problem Codes FDA CDRH C50716 Pupillary Block An obstruction of the pupil. Block, pupillary FDA C54450 Patient Problem Codes FDA CDRH C50717 Purulent Discharge Consisting of or containing pus; associated with the formation of or caused by pus. Discharge, purulent FDA C54450 Patient Problem Codes FDA CDRH C50718 Pus FDA C54450 Patient Problem Codes FDA CDRH C50409 Pyrogenic FDA C54450 Patient Problem Codes FDA CDRH C50721 Quadriplegia Paralysis of all four limbs. FDA C54450 Patient Problem Codes FDA CDRH C61395 R on T phenomenon The occurrence of a premature ventricular complex near the peak of the T wave in electrocardiography; it may lead to ventricular tachycardia or fibrillation. FDA C54450 Patient Problem Codes FDA CDRH C50722 Radiation burn A burn caused by exposure to x-ray, radium, sunlight, atomic or any other type of radiant energy. Burn, Radiation FDA C54450 Patient Problem Codes FDA CDRH C61401 Radiation Exposure, Unintended FDA C54450 Patient Problem Codes FDA CDRH C50862 Radiation Overdose Overdose of radiation FDA C54450 Patient Problem Codes FDA CDRH C61400 Radiation Overexposure FDA C54450 Patient Problem Codes FDA CDRH C50723 Radiation Sickness Syndrome Radiation induced skin desquamation Syndrome, radiation sickness|Sickness syndrome, radiation FDA C54450 Patient Problem Codes FDA CDRH C52354 Radiation Underdose Underdose, radiation FDA C54450 Patient Problem Codes FDA CDRH C61399 Radiation Underexposure FDA C54450 Patient Problem Codes FDA CDRH C3349 Radiodermatitis A cutaneous inflammatory reaction occurring as a result of exposure to biologically effective levels of ionizing radiation. FDA C54450 Patient Problem Codes FDA CDRH C50637 Range Of Motion, Loss Of Motion, loss of range of|Loss of range of motion FDA C54450 Patient Problem Codes FDA CDRH C39594 Rash FDA C54450 Patient Problem Codes FDA CDRH C50724 Raynauds Phenomenon Intermittent bilateral attacks of ischemia of the fingers or toes and sometimes of the ears or nose, marked by severe pallor, and often accompanied by paresthesia and pain. Phenomenon, Raynauds FDA C54450 Patient Problem Codes FDA CDRH C25637 Reaction FDA C54450 Patient Problem Codes FDA CDRH C3508 Reaction, Injection Site Injection site reaction FDA C54450 Patient Problem Codes FDA CDRH C50419 Reaction, Local Local reaction FDA C54450 Patient Problem Codes FDA CDRH C50720 Reaction, Pyrogenic A physical response to the presence of endotoxins in the bloodstream, which is characterized by fever and occasionally chills and shaking rigors. Pyrogenic reaction FDA C54450 Patient Problem Codes FDA CDRH C50725 Red Eye(s) Lay term applied to any condition with dilation of conjunctival or ciliary blood vessels; innumerable causes, especially irritation and infection. Eye(s), red FDA C54450 Patient Problem Codes FDA CDRH C50726 Regurgitation Flow in the opposite direction from normal, as the casting up of undigested food or gas from the stomach, or the backward flowing of blood into the heart, or between the chambers of the heart when a valve is incompetent. FDA C54450 Patient Problem Codes FDA CDRH C50797 Regurgitation, Valvular Regurgitation of the blood of the heart valves owning to imperfect closing, insufficiency or incompetency of the valves. Valvular regurgitation FDA C54450 Patient Problem Codes FDA CDRH C50820 Reinfusion FDA C54450 Patient Problem Codes FDA CDRH C50828 Reintubate FDA C54450 Patient Problem Codes FDA CDRH C9439 Renal Disease, End Stage Chronic, irreversible renal failure. Disease (ESRD), end stage renal|ESRD|Renal disease (ESRD), end stage|End stage renal disease (ESRD)|ESRD, end stage renal disease FDA C54450 Patient Problem Codes FDA CDRH C4376 Renal failure Failure, renal FDA C54450 Patient Problem Codes FDA CDRH C50727 Reocclusion FDA C54450 Patient Problem Codes FDA CDRH C50728 Respiratory Acidosis A state due to excess retention of carbon dioxide in the body. Acidosis, Respiratory FDA C54450 Patient Problem Codes FDA CDRH C50729 Respiratory Alkalosis A pathologic condition resulting from accumulation of base, or from loss of acid without comparable loss of base in the body fluids, and characterized by decrease in hydrogen ion concentration. FDA C54450 Patient Problem Codes FDA CDRH C27165 Respiratory Distress Distress, respiratory FDA C54450 Patient Problem Codes FDA CDRH C27560 Respiratory Distress Syndrome Of Newborns A condition of the newborn marked by dyspnea with cyanosis, most frequently occurring in premature infants, children of diabetic mothers and infants delivered by cesarean section, and sometimes with no predisposing cause. RDS, respiratory distress syndrome of newborns|RDS Of Newborns|Newborns (RDS), respiratory distress syndrome of|Respiratory distress syndrome of newborns (RDS)|Syndrome of newborns (RDS), respiratory distress FDA C54450 Patient Problem Codes FDA CDRH C26872 Respiratory failure Failure, respiratory FDA C54450 Patient Problem Codes FDA CDRH C50474 Respiratory Rate, Decreased Decreased respiratory rate|Rate of respiration, decreased FDA C54450 Patient Problem Codes FDA CDRH C50767 Respiratory Rate, Increased Increased respiratory rate|Rate of respiration, increased FDA C54450 Patient Problem Codes FDA CDRH C50822 Resuscitation FDA C54450 Patient Problem Codes FDA CDRH C50731 Retina, Damage To Damage to retina FDA C54450 Patient Problem Codes FDA CDRH C34979 Retina, Degeneration Of Degeneration of retina FDA C54450 Patient Problem Codes FDA CDRH C50732 Retina, Tear(s) In FDA C54450 Patient Problem Codes FDA CDRH C50406 Retrograde FDA C54450 Patient Problem Codes FDA CDRH C50427 Retrograde Flow Flow, retrograde FDA C54450 Patient Problem Codes FDA CDRH C34882 Rheumatic Heart Disease Disease, rheumatic heart|Heart disease, rheumatic FDA C54450 Patient Problem Codes FDA CDRH C50733 Right Ventricular Dysfunction Dysfunction, right ventricular FDA C54450 Patient Problem Codes FDA CDRH C50846 Right Ventricular Failure Failure of proper functioning of the right ventricle, with venous engorgement, hepatic enlargement, and subcutaneous edema. Failure, right ventricular|Ventricular failure, right FDA C54450 Patient Problem Codes FDA CDRH C50734 Right Ventricular Hypertrophy Enlargement or overgrowth of the myocardium of the right ventricle, due chronic pressure overload. Hypertrophy, right ventricular|Ventricular hypertrophy, right FDA C54450 Patient Problem Codes FDA CDRH C9445 Rupture FDA C54450 Patient Problem Codes FDA CDRH C50735 Rupture Due To Stress From Capsular Contracture Capsular contracture, rupture due to stress from|Stress from capsular contracture, rupture due to FDA C54450 Patient Problem Codes FDA CDRH C50827 Scar Excision Excision, scar FDA C54450 Patient Problem Codes FDA CDRH C50737 Scar Tissue Formation of new tissue formed in the healing of a wound. Cicatrix|Tissue, scar FDA C54450 Patient Problem Codes FDA CDRH C34483 Scarring FDA C54450 Patient Problem Codes FDA CDRH C26746 Scleroderma FDA C54450 Patient Problem Codes FDA CDRH C21097 Sedation FDA C54450 Patient Problem Codes FDA CDRH C2962 Seizures Convulsion FDA C54450 Patient Problem Codes FDA CDRH C50436 Seizures, Absence The seizure seen in absence epilepsy, consisting of a sudden momentary break in consciousness of thought or activity, often accompanied by automatisms or clonic movements, especially of the eyelids. Petit-mal seizures|Seizures, Petit-Mal FDA C54450 Patient Problem Codes FDA CDRH C50689 Seizures, Focal Partial seizure. Focal seizuresl FDA C54450 Patient Problem Codes FDA CDRH C50847 Seizures, Focal Motor A simple partial seizure consisting of clonus or spasm of a muscle or muscle group; it may be single or in a continuous and repetitive series or may spread to adjacent muscles. Focal motor seizures FDA C54450 Patient Problem Codes FDA CDRH C50574 Seizures, Grand-Mal A symptomatic form of epilepsy often preceded by an aura; characterized by loss of consciousness with generalized tonic- clonic seizures. Grand-mal seizures FDA C54450 Patient Problem Codes FDA CDRH C25201 Sensitivity FDA C54450 Patient Problem Codes FDA CDRH C50738 Sensitization Administration of antigen to induce a primary immune response; exposure to allergen that results in the development of hypersensitivity. FDA C54450 Patient Problem Codes FDA CDRH C3364 Sepsis FDA C54450 Patient Problem Codes FDA CDRH C50739 Seroma A tumor-like collection of serum in the tissues. FDA C54450 Patient Problem Codes FDA CDRH C50740 Severed Digit(s), (finger or toe) Digits (finger or toe), severed|Finger or toe, severed|Toe or finger, severed FDA C54450 Patient Problem Codes FDA CDRH C38038 Shaking/Tremors Tremors/shaking FDA C54450 Patient Problem Codes FDA CDRH C35016 Shock FDA C54450 Patient Problem Codes FDA CDRH C50452 Shock, Acoustic Acoustic Shock FDA C54450 Patient Problem Codes FDA CDRH C50460 Shock, Anaphylactic Systemic anaphylaxis is the most dramatic example of an immediate hypersensitivity reaction; is uncommon and unexpected in nature and occasionally results in a fatal outcome. Anaphylactic shock|Anaphylaxis FDA C54450 Patient Problem Codes FDA CDRH C50482 Shock, Cardiogenic Shock resulting from primary failure of the heart in its pumping function, as in myocardial infarction, severe cardiomyopathy, or mechanical obstruction or compression of the heart. Cardiogenic shock FDA C54450 Patient Problem Codes FDA CDRH C50596 Shock, Hypovolemic Shock resulting from insufficient blood volume for the maintenance of adequate cardiac output, blood pressure and tissue perfusion. Hypovolemic shock FDA C54450 Patient Problem Codes FDA CDRH C50615 Shock, Insulin A hypoglycemic reaction to overdosage of insulin, a skipped meal, or strenuous exercise in an insulin-dependent diabetic. Insulin shock FDA C54450 Patient Problem Codes FDA CDRH C50671 Shock, Neurogenic Shock resulting from neurogenic vasodilation, which can be produced by cerebral trauma or hemorrhage, spinal cord injury, deep general or spinal anesthesia, or toxic central nervous system depression. Neurogenic shock FDA C54450 Patient Problem Codes FDA CDRH C50703 Shock, Postoperative A state of shock following a surgical operation. Postoperative shock FDA C54450 Patient Problem Codes FDA CDRH C35018 Shock, septic Septic shock FDA C54450 Patient Problem Codes FDA CDRH C35019 Shock, Surgical Surgical shock FDA C54450 Patient Problem Codes FDA CDRH C50782 Shock, Traumatic Any shock produced by trauma. Traumatic shock FDA C54450 Patient Problem Codes FDA CDRH C50741 Sinus, Perforation Of Perforation of sinus FDA C54450 Patient Problem Codes FDA CDRH C26883 Sjogren's Syndrome Syndrome, sjogren's FDA C54450 Patient Problem Codes FDA CDRH C3327 Skin Discoloration Discoloration of skin FDA C54450 Patient Problem Codes FDA CDRH C50845 Skin Erosion A gradual breakdown or very shallow ulceration of the skin which involves only the epidermis and heals without scarring. Erosion, skin FDA C54450 Patient Problem Codes FDA CDRH C2983 Skin Inflammation Inflammation of skin FDA C54450 Patient Problem Codes FDA CDRH C50743 Skin Irritation Irritation of skin FDA C54450 Patient Problem Codes FDA CDRH C50744 Skin Tears FDA C54450 Patient Problem Codes FDA CDRH C3376 Sleep Disturbances Disturbances, sleep FDA C54450 Patient Problem Codes FDA CDRH C50746 Sneezing FDA C54450 Patient Problem Codes FDA CDRH C50747 Sore Throat Throat, sore FDA C54450 Patient Problem Codes FDA CDRH C50748 Soreness FDA C54450 Patient Problem Codes FDA CDRH C50750 Spinal Cord Injury Injury, spinal cord FDA C54450 Patient Problem Codes FDA CDRH C50751 Spinal Injury Injury, spinal FDA C54450 Patient Problem Codes FDA CDRH C48060 Spotting FDA C54450 Patient Problem Codes FDA CDRH C35035 Sprain FDA C54450 Patient Problem Codes FDA CDRH C41330 ST Segment Depression Depression, ST segment FDA C54450 Patient Problem Codes FDA CDRH C50540 ST Segment Elevation Evaluation of the interval from the end of ventricular depolarization to the onset of the T wave; it is usually isoelectric in normal subjects. Elevation, ST segment FDA C54450 Patient Problem Codes FDA CDRH C50752 Stacking Breaths Condition where there are a greater number of inhalations relative to the number of exhalations. Breaths, stacking FDA C54450 Patient Problem Codes FDA CDRH C50753 Staining FDA C54450 Patient Problem Codes FDA CDRH C50921 Staphylococcus Aureus S. aureus FDA C54450 Patient Problem Codes FDA CDRH C50754 Stenosis Narrowing or stricture of a duct or canal. Stricture FDA C54450 Patient Problem Codes FDA CDRH C50755 Stent Distortion Distortion, stent FDA C54450 Patient Problem Codes FDA CDRH C50664 Stiffness, Neck Neck stiffness FDA C54450 Patient Problem Codes FDA CDRH C50756 Strangulation Chocking or arrest of respiration due to occlusion of the air passageway; arrest of circulation in a part due to compression. FDA C54450 Patient Problem Codes FDA CDRH C50760 Subepithelial Infiltration Infiltration, subepithelial FDA C54450 Patient Problem Codes FDA CDRH C50911 Sudden Cardiac Death Cardiac death, sudden|Death, sudden cardiac FDA C54450 Patient Problem Codes FDA CDRH C50762 Suffocation The stopping of respiration or the asphyxia that results from it. FDA C54450 Patient Problem Codes FDA CDRH C50763 Sunset Syndrome Decentration, or malposition of intraocular lens; zonular dehiscence or lens malposition caused by zonular or parsplana fixation. Syndrome, sunset FDA C54450 Patient Problem Codes FDA CDRH C50823 Surgery, Prolonged Prolonged surgery FDA C54450 Patient Problem Codes FDA CDRH C50835 Surgical Incision, Enlargement Of FDA C54450 Patient Problem Codes FDA CDRH C15329 Surgical Procedure Procedure, surgical FDA C54450 Patient Problem Codes FDA CDRH C50421 Surgical Procedure Aborted/Stopped Procedure aborted/stopped, surgical FDA C54450 Patient Problem Codes FDA CDRH C50831 Surgical Procedure, Additional Procedure, additional surgical FDA C54450 Patient Problem Codes FDA CDRH C50422 Surgical Procedure, Delayed Procedure, delayed surgical FDA C54450 Patient Problem Codes FDA CDRH C50830 Surgical Procedure, Repeated Procedure repeated, surgical|Surgical procedure, repeated FDA C54450 Patient Problem Codes FDA CDRH C50833 Surgical Procedure, Unnecessary Procedure, unnecessary surgical FDA C54450 Patient Problem Codes FDA CDRH C50868 Suture Abrasion FDA C54450 Patient Problem Codes FDA CDRH C36172 Sweating FDA C54450 Patient Problem Codes FDA CDRH C3399 Swelling FDA C54450 Patient Problem Codes FDA CDRH C50764 Swollen Glands Glands, swollen FDA C54450 Patient Problem Codes FDA CDRH C50765 Swollen Lymph Nodes Lymph nodes, swollen|Nodes, swollen lymph FDA C54450 Patient Problem Codes FDA CDRH C35053 Syncope Faint FDA C54450 Patient Problem Codes FDA CDRH C50766 Synovitis Inflammation of a synovial membrane. FDA C54450 Patient Problem Codes FDA CDRH C38029 Tachycardia Heart Rate, Increased|Increased heart rate FDA C54450 Patient Problem Codes FDA CDRH C50552 Tearing, Excessive Excessive tearing FDA C54450 Patient Problem Codes FDA CDRH C50778 Teeth, Sensitivity Of Sensitivity Of Tooth FDA C54450 Patient Problem Codes FDA CDRH C50844 Tentorial Tears Pertaining to tears involving the tentorium of the cerebellum. Tears, tentorial FDA C54450 Patient Problem Codes FDA CDRH C50916 Teratogenic Effects Effects, teratogenic FDA C54450 Patient Problem Codes FDA CDRH C50789 Therapeutic Effects, Unexpected Effects, unexpected therapeutic|Unexpected therapeutic effects FDA C54450 Patient Problem Codes FDA CDRH C50526 Therapeutic Response, Decreased Decreased therapeutic response|Response, decreased therapeutic FDA C54450 Patient Problem Codes FDA CDRH C50611 Therapeutic Response, Increased Response, increased therapeutic|Increased therapeutic response FDA C54450 Patient Problem Codes FDA CDRH C50423 Therapy/Non-Surgical Treatment, Aborted/Stopped Treatment (non-surgical)/therapy, aborted/stopped|Non-surgical treatment/therapy, aborted/stopped FDA C54450 Patient Problem Codes FDA CDRH C50424 Therapy/Non-Surgical Treatment, Additional Non-surgical treatment/therapy, additional FDA C54450 Patient Problem Codes FDA CDRH C50425 Therapy/Non-Surgical Treatment/Delayed/Prolonged Therapy/non-surgical treatment, delayed|Treatment (non-surgical)/therapy, delayed|Non-surgical treatment/therapy, delayed FDA C54450 Patient Problem Codes FDA CDRH C50769 Thinning Of Tissue FDA C54450 Patient Problem Codes FDA CDRH C28195 Thromboembolism FDA C54450 Patient Problem Codes FDA CDRH C26891 Thrombosis FDA C54450 Patient Problem Codes FDA CDRH C27083 Thrombus An aggregation of blood factors, primarily platelets and fibrin with entrapment of cellular elements, frequently causing vascular obstruction at the point of its formation. FDA C54450 Patient Problem Codes FDA CDRH C50770 Thyroid Problems Problems, thyroid FDA C54450 Patient Problem Codes FDA CDRH C50771 Tingling A sensation as of repetitive pin pricks, caused by cold or by striking a nerve, or as a result of various diseases of the central or peripheral nervous system. FDA C54450 Patient Problem Codes FDA CDRH C50772 Tinnitus A noise in the ears, such as ringing, buzzing, roaring, clicking. Ears, ringing in|Ringing in ears FDA C54450 Patient Problem Codes FDA CDRH C61375 Tissue Breakdown FDA C54450 Patient Problem Codes FDA CDRH C50773 Tissue Damage Damage, tissue FDA C54450 Patient Problem Codes FDA CDRH C50775 Tissue Failure Failure, tissue FDA C54450 Patient Problem Codes FDA CDRH C50779 Torsades-De-Pointes 'Fringe of pointed tips'; An atypical rapid ventricular tachycardia with periodic waxing and waning of amplitude of the QRS complexes on the electrogram as well as rotation of the complexes about the isoelectric line. FDA C54450 Patient Problem Codes FDA CDRH C50780 Toxemia The condition resulting from the spread of bacterial products (toxins) by the bloodstream. FDA C54450 Patient Problem Codes FDA CDRH C35498 Toxic Shock Syndrome A severe illness caused by infection with staphylococcus aureus and characterized by high fever of sudden onset, vomiting, diarrhea, and myalgia, followed by hypotension and in severe cases, shock; a sunburn-like rash with peeling of the skin, especially of the palms and soles, occurs during the acute phase. Shock syndrome (TSS), toxic|TSS, toxic shock syndrome|Toxic shock syndrome, (TSS)|Syndrome (TSS), toxic shock|TSS FDA C54450 Patient Problem Codes FDA CDRH C27990 Toxicity FDA C54450 Patient Problem Codes FDA CDRH C50493 Toxins In Children Children affected by toxins may be due to silicone breast implants and their effects on unborn children and from breastfeeding. Children, toxins in FDA C54450 Patient Problem Codes FDA CDRH C50454 Toxoplasmosis, Acquired Acquired as an adult. Acquired toxoplasmosis FDA C54450 Patient Problem Codes FDA CDRH C50503 Toxoplasmosis, Congenital Passed from mother to fetus. Congenital toxoplasmosis FDA C54450 Patient Problem Codes FDA CDRH C15341 Tracheostomy FDA C54450 Patient Problem Codes FDA CDRH C15192 Transfusion Of Blood Products Blood products, transfusion of FDA C54450 Patient Problem Codes FDA CDRH C50832 Transfusion with incompatible blood Blood, transfusion with incompatible|Incompatible blood, transfusion with FDA C54450 Patient Problem Codes FDA CDRH C50781 Transient Ischemic Attack A brief attack (from a few minutes to an hour) of cerebral dysfunction of vascular origin, with no persistent neurological deficit. Attack, transient ischemic|Ischemic attack, transient FDA C54450 Patient Problem Codes FDA CDRH C50920 Transplant Of Organ/Tissue Organ/tissue transplant|Tissue/organ transplant FDA C54450 Patient Problem Codes FDA CDRH C15986 Treatment With Medication(s) Medication(s), treatment with FDA C54450 Patient Problem Codes FDA CDRH C50842 Tricuspid Insufficiency Incomplete closure of the tricuspid valve, resulting in tricuspid regurgitation; it is usually secondary to systolic overload in the right ventricle. Insufficiency, tricuspid FDA C54450 Patient Problem Codes FDA CDRH C50843 Tricuspid Regurgitation The backflow of blood from the right ventricle into the right atrium, owning to imperfect functioning/insufficiency of the tricuspid valve. Regurgitation, tricuspid FDA C54450 Patient Problem Codes FDA CDRH C50783 Tricuspid Stenosis Narrowing or stricture of the tricuspid orifice of the heart. Stenosis, tricuspid FDA C54450 Patient Problem Codes FDA CDRH C50816 Tricuspid Valve Replacement Replacement of tricuspid valve|Valve, replacement of tricuspid FDA C54450 Patient Problem Codes FDA CDRH C50784 Twiddlers Syndrome Dislodgement, breakdown, or other malfunction of an artificial cardiac pacemaker, chemotherapy port, drip infusion valve, or similar implanted diagnostic or therapeutic device as a result of unconscious or habitual manipulation by the patient. Syndrome, twiddler's FDA C54450 Patient Problem Codes FDA CDRH C50785 Twitching The occurrence of a single contraction or a series of contractions of a muscle. FDA C54450 Patient Problem Codes FDA CDRH C50794 UGH (Uveitis-Glaucoma-Hyphema) Syndrome For complications that occur secondary to intraocular lens implantation in the anterior chamber; caused by rubbing of the lens loop (haptics). Syndrome, uveitis-glaucoma-hyphema (UGH)|Uveitis-glaucoma-hyphema (UGH) syndrome FDA C54450 Patient Problem Codes FDA CDRH C3426 Ulcer FDA C54450 Patient Problem Codes FDA CDRH C25757 Ulceration FDA C54450 Patient Problem Codes FDA CDRH C50407 Under No Medication Medication, not under FDA C54450 Patient Problem Codes FDA CDRH C50408 Under No Sedation Sedation, not under FDA C54450 Patient Problem Codes FDA CDRH C17998 Unknown Unknown|Unknown (for use when the device problem is not known)|Unknown (For Use When The Patients Condition Is Not Known) FDA C54450 Patient Problem Codes FDA CDRH C34851 Uremia FDA C54450 Patient Problem Codes FDA CDRH C50792 Urgency A sudden compelling urge to urinate. FDA C54450 Patient Problem Codes FDA CDRH C26906 Urinary Frequency Frequency, urinary FDA C54450 Patient Problem Codes FDA CDRH C50790 Urinary Retention Accumulation of urine within the bladder because of the inability to urinate. Retention, urinary FDA C54450 Patient Problem Codes FDA CDRH C3432 Urticaria Urticaria. Hives FDA C54450 Patient Problem Codes FDA CDRH C50793 Uterine Perforation Perforation of uterus FDA C54450 Patient Problem Codes FDA CDRH C26909 Uveitis FDA C54450 Patient Problem Codes FDA CDRH C50795 Vaginal Discharge Discharge, vaginal FDA C54450 Patient Problem Codes FDA CDRH C50522 Vaginal Mucosa Damage Damage, vaginal mucosa|Mucosa damage, vaginal FDA C54450 Patient Problem Codes FDA CDRH C50709 Valve Thrombosis FDA C54450 Patient Problem Codes FDA CDRH C40866 Vasoconstriction Vasospasm FDA C54450 Patient Problem Codes FDA CDRH C40867 Vasodilatation A state of increased caliber of the blood vessels. FDA C54450 Patient Problem Codes FDA CDRH C50798 Vaso-Vagal Response FDA C54450 Patient Problem Codes FDA CDRH C3365 Venereal Disease Any contagious disease acquired during sexual contact; e.g. syphilis, gonorrhea, chancroid. Disease (VD), venereal|VD|Venereal disease (VD)|VD, venereal disease FDA C54450 Patient Problem Codes FDA CDRH C28221 Venipuncture FDA C54450 Patient Problem Codes FDA CDRH C50430 Ventilator Dependent Dependent, ventilator FDA C54450 Patient Problem Codes FDA CDRH C50448 Ventricle, Abnormality Of FDA C54450 Patient Problem Codes FDA CDRH C50799 Ventricular Fibrillation Arrhythmia characterized by fibrillary contractions of the ventricular muscle due to rapid repetitive excitation of myocardial fibers without coordinated contraction of the ventricle. Fibrillation, ventricular FDA C54450 Patient Problem Codes FDA CDRH C50800 Ventricular Flutter A ventricular tachyarrhythmia characterized electrocardiographically by smooth undulating waves with QRS complexes merged with T waves, a rate of approximately 250 per minute. Flutter, ventricular FDA C54450 Patient Problem Codes FDA CDRH C50801 Ventricular Perforation Perforation, ventricular FDA C54450 Patient Problem Codes FDA CDRH C50802 Ventricular Tachycardia An abnormally rapid ventricular rhythm with aberrant ventricular excitation, usually in excess of 150 beats per minute. FDA C54450 Patient Problem Codes FDA CDRH C50803 Ventriculomeglia FDA C54450 Patient Problem Codes FDA CDRH C38057 Vertigo FDA C54450 Patient Problem Codes FDA CDRH C50647 Vessel Or Plaque, Device Embedded In Device and/or fragments of device are embedded in patient's vessel and/or plaque. Device embedded in vessel or plaque|Plaque or vessel, device embedded in FDA C54450 Patient Problem Codes FDA CDRH C50804 Vessels, Perforation Of Perforation of vessel(s) FDA C54450 Patient Problem Codes FDA CDRH C14283 Virus FDA C54450 Patient Problem Codes FDA CDRH C50602 Vision, Impaired Impaired vision FDA C54450 Patient Problem Codes FDA CDRH C50638 Vision, Loss Of Loss of vision FDA C54450 Patient Problem Codes FDA CDRH C50805 Visual Disturbances Disturbances, visual FDA C54450 Patient Problem Codes FDA CDRH C50837 Vitrectomy FDA C54450 Patient Problem Codes FDA CDRH C50808 Vitreous floaters Spots before the eyes; deposits in the vitreous of the eye, usually moving about and probably representing fine aggregates of vitreous protein occurring as a benign degenerative change. Floaters, Vitreous FDA C54450 Patient Problem Codes FDA CDRH C50469 Vitreous Fluid, Blood In Blood in vitreous fluid|Fluid, blood in vitreous FDA C54450 Patient Problem Codes FDA CDRH C50639 Vitreous Fluid, Loss Of Fluid, loss of vitreous|Loss of vitreous fluid FDA C54450 Patient Problem Codes FDA CDRH C50807 Vitreous, Detachment Of Detachment of vitreous FDA C54450 Patient Problem Codes FDA CDRH C50587 Vitritis Inflammatory intraocular reaction with clouding and cells in vitreous; often accompanies inflammation of ciliary body, iris, choroid, or retina. FDA C54450 Patient Problem Codes FDA CDRH C3442 Vomiting FDA C54450 Patient Problem Codes FDA CDRH C50809 Weakness FDA C54450 Patient Problem Codes FDA CDRH C50810 Weight Fluctuations Fluctuations of weight FDA C54450 Patient Problem Codes FDA CDRH C50811 Wheal(s) A smooth, slightly elevated area on the body surface, which is redder or paler than the surrounding skin. It is the typical lesion of urticaria, the dermal evidence of allergy, and in sensitive persons may be provoked by mechanical irritation of the skin. Welt(s) FDA C54450 Patient Problem Codes FDA CDRH C50863 Wound Dehiscence Separation of the layers of a surgical wound; it may be partial and superficial only, or complete with disruption of all layers. Dehiscence wound FDA C54450 Patient Problem Codes FDA CDRH C50704 Wound Infection, Post-Operative Infection, post-operative wound|Post-operative wound infection FDA C54450 Patient Problem Codes FDA CDRH C50705 Wound Infection, Post-Traumatic Infection, post-traumatic wound|Post-traumatic wound infection FDA C54450 Patient Problem Codes FDA CDRH C50435 Wrinkling