NCIt Version# 08.08d Report Date: 09/05/2008 (RWW) Source Subset Code Subset Name NCIt Concept Code Source (FDA CDRH) Code Source PT (FDA CDRH PT) Source Synonym(s) (FDA CDRH) SYs Source (FDA CDRH) Definition NCI Definition Parent Concept's NCIt Concept Code Parent Concept's Source Code (Parent Concept's FDA CDRH Code) Parent Concept's Source PT (Parent Concept's FDA CDRH PT) Parent Concept's NCIt PT (Only for Concepts that Do Not Have Source PT) Second Parent Concept's NCIt Concept Code Second Parent Concept's NCIt PT (Only for Concepts that Do Not Have Source PT) FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49805 968 Sound absorber C50372 Absorber FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49806 548 Accumulator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49807 402 Actuator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49808 431 Adapter (Adaptor) C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49809 966 Socket adaptor C49808 431 Adapter (Adaptor) FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49810 552 Air cleaner C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49811 549 Air pump assembly C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49812 404 Alarm, assembly C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49813 403 Alarm C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49814 405 Alarm, audible C49813 403 Alarm FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49815 408 Alarm, LED C49813 403 Alarm FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49816 412 Alarm, pressure C49813 403 Alarm FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49817 407 Alarm, high inspiratory pressure C49816 412 Alarm, pressure FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49818 410 Alarm, oxygen pressure C49816 412 Alarm, pressure FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49819 409 Alarm, low inspiratory pressure C49816 412 Alarm, pressure FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49820 411 Alarm, power C49813 403 Alarm FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49821 550 Alarm, self C49813 403 Alarm FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49822 413 Alarm, visual C49813 403 Alarm FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49823 414 Alarm, volume C49813 403 Alarm FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49824 590 Alternator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49825 592 Amplifier C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49826 593 Analyzer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49827 594 Annunciator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49828 595 Antenna C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49829 596 Arrester C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49830 597 Attenuator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49831 598 Backpanel C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49832 599 Backplane C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49833 730 Baffle C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49834 553 Bags C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49835 418 Ball C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49836 731 Ballast C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49837 419 Balloon C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49838 732 Barrier A structure or object that impedes free movement. C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49839 420 Battery C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49840 479 Lithium iodide battery C49839 420 Battery FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49841 733 Beam splitter C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49842 734 Bearings C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49843 735 Bell C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49844 737 Belt C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49845 738 Blower C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49846 739 Bobbin C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49847 741 Bolt C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49848 554 Bottom dead center sensor bracket C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49849 742 Brake C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49850 422 Breathing circuit C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49851 743 Brush C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49852 745 Bus C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49853 746 Bushing C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49854 736 Buzzer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49855 423 Cable C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49856 894 Optical cable C49855 423 Cable FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49857 747 Calibrator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49858 748 Camera An apparatus for taking photographs, generally consisting of a lightproof enclosure having an aperture with a shuttered lens through which the image of an object is focused and recorded on a photosensitive film or plate. C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49859 749 Cannula, inner C50343 Cannula FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49860 750 Cannula, outer C50343 Cannula FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49861 424 Cap C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49862 751 Capacitor Capacitor (ceramic chip) C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49863 752 Carrier C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49864 556 Cascade C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49865 425 Cassette C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49866 753 Caster C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49867 754 Cell C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49868 426 Charger C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49869 755 Chassis C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49870 756 Choke C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49871 427 Circuit board C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49872 757 Clamp C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49873 758 Clip C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49874 759 Clock C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49875 429 CO2 monitor subassembly (only use when part of another device) C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49876 760 Coder C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49877 761 Coil A structure consisting of something wound in a continuous series of loops. C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49878 559 Conductor coil C49877 761 Coil FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49879 586 Tip conductor coil C49877 761 Coil FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49880 567 Helifix coil C49877 761 Coil FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49881 762 Collimator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49882 763 Comparator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49883 558 Concentrator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49884 560 Connecting rod C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49885 435 Connector C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49886 545 Y-piece connector C49885 435 Connector FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49887 765 Controller C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49888 766 Converter C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49890 768 Cord C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49892 497 Power cord C49890 768 Cord FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49893 769 Core C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49894 770 Counter C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49895 771 Coupler C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49896 772 Cover C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49897 437 CPU (central processing unit) board C61402 Computer Hardware FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49898 561 Crank arm assembly C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49899 773 Crystal C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49900 562 Cuff A bandlike device or structure that encircles a body part or another device. C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49901 774 Cups C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49902 775 Current limiter C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49903 776 Current source C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49904 439 Cusp C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49905 777 Cutter C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49906 440 Cylinder C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49907 778 Damper C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49908 780 Decoder C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49909 442 Defibrillator paddles C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49910 443 Defibrillator subassembly (only use when part of another device) C53996 Device Subassembly FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49911 781 Dehumidifier C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49912 782 Dehydrator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49913 783 Delay line C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49914 784 Demagnetizer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49915 785 Demodulator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49916 787 Detector C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49917 902 Photodetector C49916 787 Detector FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49918 788 Device deployer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49919 789 Dial C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49920 445 Diaphragm C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49921 790 Digitizer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49922 447 Diode C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49923 477 LED (light emitting diode) C49922 447 Diode FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49924 448 Discrete component/device (resistor, capacitor, diode) C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49925 791 Disk C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49926 893 Optical disk C49925 791 Disk FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49927 416 Display C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49928 792 Divider C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49929 793 Dome C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49930 794 Doubler C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49931 795 Driver C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49932 796 Duct C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49933 797 Dummy load C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49934 798 Duplexer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49935 449 EKG/ECG subassembly (only use when part of another device) C53996 Device Subassembly FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49936 451 Electrode A conductor used to make electrical contact with some part of a circuit. C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49937 799 Emitter C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49938 800 Enclosure C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49939 801 Encoder C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49940 802 Endoscope C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49941 803 Equalizer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49942 804 Evaporator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49943 805 Expander C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49944 806 Extender C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49945 807 Extractor C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49946 808 Eyelet C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49947 809 Fan C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49948 810 Fastener C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49949 811 Feedthru C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49950 812 Ferrule C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49951 813 FET (field effect transistor) C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49952 814 Fiber C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49953 468 Hollow fiber C49952 814 Fiber FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49954 546 Optical fiber C49952 814 Fiber FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49955 815 Film C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49956 816 Filter C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49957 455 Exhalation filter C49956 816 Filter FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49958 417 Bacterial filter C49956 816 Filter FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49959 457 Flange C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49960 817 Flasher C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49961 818 Foil C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49962 819 Foot pedal C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49963 820 Frame C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49964 564 Function lid C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49965 821 Furnace C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49966 822 Fuse C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49967 461 Gas scavenging C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49968 823 Gasket C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49969 565 Gears Gear C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49970 825 Generator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49971 826 Grille C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49972 827 Grommet C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49973 828 Ground strap C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49974 829 Guide C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49975 576 Piston guides C49974 829 Guide FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49976 2853 Waveguide C49974 829 Guide FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49977 830 Handset C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49978 464 Header C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49979 831 Headphone C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49980 832 Heads C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49981 577 Piston heads C49980 832 Heads FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49982 833 Headset C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49983 465 Heart valve cage C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49984 835 Heat exchanger C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49985 836 Heat sink C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49986 467 Heater C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49987 566 Heater rod C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49988 837 Hinge C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49989 838 Holder C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49990 839 Housing C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49991 469 Hub C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49992 470 Humidifier C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49993 471 Hybrid circuit C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49994 474 IC (integrated circuit) C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49995 472 IC (integrated circuit) chip C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49996 840 Igniter C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49997 841 Imager C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49998 842 Impedance converter C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C49999 851 IOL (intraocular lens) implant C50030 866 Lenses FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50000 843 Indexer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50001 844 Indicator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50002 460 Function indicator C50001 844 Indicator FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50003 845 Inductor C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50004 473 Insulation C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50005 846 Integrator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50006 847 Intercom C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50007 569 Interconnection board intubate C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50008 848 Interface Either a program that controls a display for the user and that allows the user to interact with the system or a computer circuit consisting of the hardware and associated circuitry that links one device with another. C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50009 849 Interrupter C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50010 850 Inverter C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50011 852 Isolator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50012 853 Jack C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50013 854 Joint C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50014 511 Solder joint C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50015 855 Joystick C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50016 856 Jumper C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50017 857 Junction C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50018 475 Keyboard C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50019 858 Keyer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50020 859 Keypad C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50021 860 Kit C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50022 861 Knob C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50023 862 Label C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50024 863 Laminate C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50025 864 Lamp C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50026 865 Laser C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50027 452 Electrical lead C50282 Lead FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50028 476 Lead conductor C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50029 466 Heart valve leaflet C50283 Leaflet FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50030 866 Lenses C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50031 764 Contact lens C50030 866 Lenses FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50032 867 Limiter C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50033 868 Line conditioner C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50034 869 Load C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50035 870 Lock C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50036 571 Locking sleeve C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50037 480 Logic board C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50038 572 Lower piston bearing C49842 734 Bearings FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50039 871 Magazine C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50040 482 Magnet A device that attracts iron and produces a magnetic field. C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50041 872 Magnetizer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50042 874 Magnetoresistor C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50043 875 Magnifier C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50044 483 Manifold C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50045 876 Matrices C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50046 484 Membrane C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50047 877 Memory Any device that can hold data in machine-readable format. C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50048 509 ROM (read only memory) A type of data storage device which is manufactured with fixed contents. ROM is inherently non-volatile storage, retaining its contents even when the power is switched off. C50047 877 Memory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50049 454 EPROM (erasable programmable read only memory) C50050 503 PROM (programmable read only memory) FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50050 503 PROM (programmable read only memory) C50048 509 ROM (read only memory) FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50051 505 RAM (random access memory) A data storage device for which the order of access to different locations does not affect the speed of access. RAM can be both read from and written to by the computer, but its contents are lost when the power is switched off. C50047 877 Memory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50052 462 Gauges/meters Meter C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50053 873 Magnetometer C50052 462 Gauges/meters FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50054 458 Flowmeter C50052 462 Gauges/meters FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50055 786 Densitometer C50052 462 Gauges/meters FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50056 740 Bolometer C50052 462 Gauges/meters FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50057 591 Altimeter C50052 462 Gauges/meters FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50058 1018 Voltmeter C50052 462 Gauges/meters FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50059 2835 Thermometer C50052 462 Gauges/meters FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50060 989 Tachometer C50052 462 Gauges/meters FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50061 972 Spectrometer C50052 462 Gauges/meters FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50062 951 Scintillometer C50052 462 Gauges/meters FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50063 926 Pyrometer C50052 462 Gauges/meters FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50064 496 Potentiometer C50052 462 Gauges/meters FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50065 490 Oximeter (only use when part of another device) Oximeter C50052 462 Gauges/meters FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50066 514 Spirometer C50052 462 Gauges/meters FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50067 879 Microcircuit C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50068 880 Microphone C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50069 881 Microscope C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50070 882 Mirror C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50071 883 Mixer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50072 884 Modem An electronic device for converting between serial data from a computer and an audio signal suitable for transmission over a telephone line connected to another modem. C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50073 885 Modulator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50074 886 Monitor C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50075 450 EKG/ECG monitor C50074 886 Monitor FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50076 485 Mother board C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50077 486 Motor C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50078 516 Stepper motor C50077 486 Motor FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50079 887 Mount C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50080 889 Nebulizer (only use when part of another device) C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50081 890 Network C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50082 573 Meter needle C50290 Needle FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50083 1023 None C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50084 891 Nuts C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50085 487 O2 monitor subassembly (only use when part of another device) C53996 Device Subassembly FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50086 488 Obturator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50087 895 Optocoupler C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50088 896 Oscillator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50089 897 Oscilloscope C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50091 898 Outlet C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50092 899 Oven C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50093 575 Overlay C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50094 491 Oxygen analyzer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50095 900 Pad C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50096 901 Panel C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50097 492 PC (printed circuit) board C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50098 903 Photomultiplier C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50099 904 Phototransistor C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50100 905 Pickup C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50101 906 Pin C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50102 583 Retaining pin C50101 906 Pin FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50103 574 Motor roll pin C50101 906 Pin FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50104 578 Piston Pads C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50105 494 Pivot C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50106 907 Plate C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50107 908 Plotter C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50108 579 Plug C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50109 910 Pointer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50110 911 Polarizer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50111 495 Port C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50112 912 Post C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50113 580 Power lamp C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50114 913 Power module C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50115 498 Power supply C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50116 914 Preamplifier C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50117 915 Prescaler C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50118 916 Preselector C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50119 581 Pressure signal C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50120 917 Printer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50121 918 Probe C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50122 919 Processor C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50123 920 Programmer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50124 504 Prong C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50125 921 Protector C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50126 923 Pulley C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50127 924 Pulser C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50128 925 Pump C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50129 557 Compressor (air pump) C50128 925 Pump FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50130 927 Rail C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50131 928 Reactor C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50132 929 Reader C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50133 930 Receiver C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50134 507 Recorder (tape, stripchart, etc.) C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50135 931 Rectifier C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50136 582 Reed (electrically open) C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50137 932 Regulator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50138 508 Relay C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50139 933 Repeater C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50140 934 Reservoir C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50141 935 Resistor C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50143 937 Resonator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50144 938 Retainer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50145 939 Reticle C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50146 941 Rheostat C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50147 942 Ribbon C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50148 943 Ring C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50149 964 Slip ring C50148 943 Ring FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50150 834 Heart valve sewing ring C50148 943 Ring FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50151 944 Rivet C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50152 945 Robot C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50153 946 Rod C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50154 947 Safety interlock C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50155 984 SAW (surface acoustic wave device) C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50156 949 Scale C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50157 948 Scaler C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50158 950 Scanner An electronic device that generates a digital representation of an image for data input to a computer. C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50159 952 Scrambler C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50160 953 Screen C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50161 568 Screw C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50162 954 Scriber C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50163 432 Seal C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50164 584 Seal tracheal C50163 432 Seal FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50165 563 Cup seal C50163 432 Seal FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50166 510 Sensor C50121 918 Probe FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50167 500 Pressure sensor C50166 510 Sensor FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50168 892 O2 sensor C50166 510 Sensor FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50169 551 Servo C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50170 955 Shaft C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50171 956 Shield C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50172 957 Shift register C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50173 958 Shifter C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50174 959 Shunt C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50175 960 Shutter C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50176 961 Signal conditioner C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50177 962 Simulator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50178 963 Slide C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50179 965 Slotter line C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50180 967 Socket C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50181 512 Solenoid C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50182 969 Spacer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50183 970 Spark gap C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50184 971 Speaker C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50185 973 Splicer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50186 974 Spooler C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50187 975 Spring C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50188 976 Stabilizer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50189 977 Stand C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50190 515 Stent C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50191 978 Stiffener C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50192 517 Stopcock C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50193 979 Strain relief C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50194 980 Strip line C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50195 518 Stylet C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50196 981 Substrate C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50197 982 Sunlamp C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50198 983 Suppressor C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50199 519 Switches C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50200 499 Power switch C50199 519 Switches FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50201 478 Limit switch C50199 519 Switches FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50202 459 Foot switch C50199 519 Switches FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50203 922 Proximity switch C50199 519 Switches FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50204 436 Control switches C50199 519 Switches FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50205 985 Synchronizer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50206 986 Synthesizer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50207 987 Syringe C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50208 456 Fail-safe system C50311 System FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50209 990 Tape C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50210 991 Tee C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50211 520 Telemetry equipment C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50212 992 Telephone C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50213 993 Teleprinter C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50214 994 Teletypewriter C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50215 996 Temperature compensator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50216 997 Terminal C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50217 585 Terminal assembly C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50218 998 Terminator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50219 999 Thermistor C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50220 1000 Thermocouple C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50221 2836 Thermostat C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50222 2837 Thyristor C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50223 2838 Timer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50224 2839 Trackball C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50225 2840 Transceiver C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50226 522 Transducer An electrical device that converts one form of energy into another. C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50227 523 Transformer A device that either steps up or steps down an alternating electrical current to an output that is suitable for another electrical device. C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50228 524 Transistor C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50229 2841 Translator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50230 2842 Transmission line C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50231 2843 Transmitter A device to propagate electromagnetic waves. C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50232 2844 Transponder C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50233 2845 Transport C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50234 2846 TRIAC Three Terminal Current Controlling Semiconductor C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50235 2847 Trimmer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50236 525 Tube C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50237 587 Tube capillary C50236 525 Tube FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50238 438 CRT (cathode ray tube) C50236 525 Tube FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50239 501 Pressure tubing C50236 525 Tube FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50240 2848 Tuner C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50241 779 Data acquisition unit C50329 Unit FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50242 995 Television unit C50329 Unit FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50243 527 Valve Valve (one-way, hemo, stopcock, etc.) C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50244 529 Valve, control C50243 527 Valve FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50245 530 Valve, directional C50243 527 Valve FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50246 589 Valve, dump C50243 527 Valve FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50247 531 Valve, exhalation C50243 527 Valve FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50248 532 Valve, flap C50243 527 Valve FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50249 533 Valve, flow C50243 527 Valve FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50250 534 Valve, inhalation C50243 527 Valve FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50251 535 Valve, inlet port C50243 527 Valve FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50252 536 Valve, inspiratory C50243 527 Valve FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50253 537 Valve, outlet port C50243 527 Valve FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50254 538 Valve, PEEP (positive end expiratory pressure) C50243 527 Valve FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50255 539 Valve, pressure limit C50243 527 Valve FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50256 540 Valve, relief C50243 527 Valve FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50257 541 Valve, safety C50243 527 Valve FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50258 542 Valve, selector C50243 527 Valve FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50259 441 Cylinder valve C50243 527 Valve FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50260 481 Luer valve C50243 527 Valve FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50261 493 Pilot balloon valve C50243 527 Valve FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50262 543 Vaporizer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50263 2849 Varistor C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50264 588 VDT (video display terminal) C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50265 2850 Vibrator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50266 2851 Viewer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50267 2852 Washer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50268 2854 Window C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50269 430 Wire C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50270 547 Thermocouple wire C50269 430 Wire FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50271 463 Guidewire C50269 430 Wire FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50272 544 Wiring harness C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50273 2855 Yoke C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50274 Cannula Guide C49974 829 Guide FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50275 Handpiece C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50276 Handrest C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50277 Haptic C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50278 Screw Head C49980 832 Heads FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50279 Hose C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50280 Hose Line C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50281 Hand immobilizer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50282 Lead An insulated electrical conductor connected to an electrical device. C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50283 Leaflet C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50284 Function Indicator Light C50002 460 Function indicator FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50285 Mechanism C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50286 Locking mechanism C50285 Mechanism FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50287 Lockout Mechanism C50285 Mechanism FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50288 Spring Loading Mechanism C50285 Mechanism FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50289 Bolus mechanism C50285 Mechanism FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50290 Needle C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50291 Nozzle C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50292 Laser nozzle C50291 Nozzle FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50293 Pallet C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50294 Tomographic Pallet C50293 Pallet FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50295 Connector Pin C50101 906 Pin FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50296 Pipette C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50297 Plunger C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50298 Intravenous Pole C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50299 Probe, Transducer Pressure C50121 918 Probe FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50300 Temperature Probe C50121 918 Probe FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50301 Side Rail C50130 927 Rail FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50302 Hermetic Seal C50163 432 Seal FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50303 Rate modulated pacing sensor C50166 510 Sensor FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50304 Temperature sensor C50166 510 Sensor FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50305 Shoulder Support C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50306 Speech Processor C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50307 Staple C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50308 Emergency Stop Button or Switch C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50309 Emergency Table Stop C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50310 Syringe Drive C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50311 System C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50312 Hydraulic System C50311 System FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50313 Hydraulic Bed System C50311 System FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50314 Gas delivery system C50311 System FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50315 Water Purification System C50311 System FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50316 Injection System Injector system C50311 System FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50317 Automatic Injection System C50316 Injection System FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50319 Cooling module Cooling System C50311 System FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50320 Table Top C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50321 Screw Tapper C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50322 Test Strip C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50323 Thread C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50324 Tip The extreme end of something, especially something pointed. C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50325 Nozzle Tip C50324 Tip FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50326 Lead Tip C50324 Tip FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50327 Trocar C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50328 Photomultiplier (PM) Tube C50236 525 Tube FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50329 Unit C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50330 Receiver Stimulator Unit C50329 Unit FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50331 Motor Drive Unit C50329 Unit FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50332 CPU (central processing unit of computer system) The part of a computer which controls all the other parts. Designs vary widely but, in general, the CPU consists of the control unit, the arithmetic and logic unit (ALU) and memory (registers, cache, RAM and ROM) as well as various temporary buffers and other logic. C61402 Computer Hardware FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50333 Stopcock Valve C50243 527 Valve FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50334 One-Way Valve C50243 527 Valve FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50335 Hemo Valve C50243 527 Valve FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50336 Electrical Wire C50269 430 Wire FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50337 Steering Wire C50269 430 Wire FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50338 Endoscopic Accessory C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50339 Air Eliminator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50341 Applicator C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50342 Cutter-Torque Cable C49855 423 Cable FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50343 Cannula A small flexible tube inserted into a body cavity for draining off fluid or introducing medication. C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50344 Catheter C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50345 Cautery C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50346 Battery Charger C49868 426 Charger FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50347 Circuit Breaker C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50348 Fiberoptic Cladding C50358 Fiberoptic FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50349 Fiberoptic Cleaver C50358 Fiberoptic FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50350 T-piece connector C49885 435 Connector FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50351 Electrode Contact C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50352 Counterbalance C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50353 Deionizer C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50354 Bubble Detector C49916 787 Detector FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50355 Motion Detector C49916 787 Detector FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50357 Leaflet Disk C50283 Leaflet FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50358 Fiberoptic C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50359 External Fiberoptic C50358 Fiberoptic FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50360 Sediment Filter C49956 816 Filter FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50361 Wedge Filter C49956 816 Filter FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50362 Fiberguide C49974 829 Guide FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50364 Surgical Graft C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50365 Suture C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50371 Table C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C50372 Absorber C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C51066 Bed, Assist Bar C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C51067 Wheel C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C51068 Wheelchair, Wheels C51067 Wheel FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C51069 Wheelchair, Tires C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C53996 Device Subassembly C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C53997 428 CO2 monitor C50074 886 Monitor FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C54008 444 User interface C50008 848 Interface FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C54010 888 Multiplier C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C54013 1024 Switch, push button C50199 519 Switches FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C54016 1025 Valve cam C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C54020 1028 Jaw C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C54021 1029 Knife C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C54022 1030 Latch C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C54023 1031 Pusher C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C61402 Computer Hardware C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C61403 Concentrate C49755 Device Component or Accessory FDA C54577 Medical_Device_Component_Or_Accessory_Terminology_CDRH C69444 Film Processor C50122 919 Processor FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C17998 Unknown Unknown|Unknown (For Use When The Patients Condition Is Not Known)|Unknown (for use when the device problem is not known) Not known, not observed, not recorded, or refused. C27993 General Qualifier FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C48660 Not Applicable Determination of a value is not relevant in the current context. C48655 Missing Value Reason FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C50433 Delamination Issue associated with peeling of composite materials. Occurs when layers are separated as a result of continuous stress or impact. Results in loss of mechanical toughness. C62878 1454 Peeled FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C50554 Expulsion Issue associated with the unintended ejection of device component materials. C62917 1395 Migration of device or device component FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C50557 Extrusion Issue associated with the unintended of projection of device component materials. C62917 1395 Migration of device or device component FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C53269 No Information Available No Answer Provided C48655 Missing Value Reason FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62804 2614 Wrinkled Wrinkling|Wrinkled material C63296 1059 Bent FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62805 1675 Volume accuracy issue Volume accuracy C63144 1233 Filling problem FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62806 1674 Vibration Issue associated with an oscillation wherein the quantity is a parameter that defines the motion of a mechanical system. C62814 Unintended movement FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62807 Ventilation issue in device environment C63209 Environmental control or utility issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62808 Facilities issue User facility issue Issue associated with the physical establishment and environment in which medical devices are transported, stored, processed, serviced or used within the user facility. C62996 2379 Device Issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62809 1667 Unstable Issue associated with the connection of device and/or device components not possessing stability, or is unbounded. C62814 Unintended movement FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62810 1444 Unsealed device packaging Packaging, unsealed C63240 Device packaging compromised FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62811 1664 Unraveled material C62970 1153 Degraded FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62812 1662 Unit inactivated C62955 Device operates differently than expected FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62813 1430 Unintended system motion System motion, unintended Issue associated with any motion of the system or components that was not initiated by the user. C62814 Unintended movement 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. C62961 1384 Mechanical issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62815 1377 Unintended magnet quench Magnet quench, unintended C62883 1437 Overheating of device or device component FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62816 1284 Unintended head motion Head motion, unintended C62814 Unintended movement FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62817 1234 Unintended ejection of film cartridge Film cartridge ejection, unintended C62955 Device operates differently than expected FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62818 1162 Unintended energization Device energization, unintended|Unintended device energization C63025 Power source issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62819 1429 Unintended collision Collision, unintended Issue associated with an unwanted condition that results from concurrent transmission on the physical medium. C62814 Unintended movement FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62820 1033 Unintended arm motion Arm motion, unintended C62814 Unintended movement FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62821 1631 Unexpected therapeutic results Therapeutic results, unexpected Issue associated with the use of a medical device for therapeutic purposes. C62848 1535 Incorrect or inadequate result FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62822 1661 Undersensing C63061 2293 Invalid sensing FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62823 2182 Insufficient flow or underinfusion Underinfusion|Underdelivery 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. C63075 Infusion or flow issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62825 1659 Uncoiled C62962 Material twisted FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62826 1516 Unable to obtain readings Readings, unable to obtain C63088 1184 Incorrect display FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62827 1656 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. C62986 Filtration issue 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. C63108 Improper device output FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62829 2456 Incorrect or inadequate test results Test results, inaccurate C62848 1535 Incorrect or inadequate result FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62830 1629 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. C63271 Communication or transmission issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62831 2385 Tear, rip or hole in device packaging Packaging, tears, rips, holes in C63240 Device packaging compromised 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. C62968 Material integrity issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62833 2170 Suction issue Suction failure 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. C63075 Infusion or flow issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62834 2538 Strikethrough C63137 1250 Fluid leak FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62835 1601 Stretched Material stretched Issue associated with an increase or elongation in a materials' dimension. C63248 Material deformation FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62836 1597 Sticking C63034 Advancement issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62837 2595 Spark Issue associated with a high voltage capacitor discharge characterized by a visible electrical glowing. C63005 Electronic property issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62838 2324 Solder joint failure C63194 1068 Loss of or failure to bond 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). C63305 Application program issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62840 1584 Slippage of device or device component Slippage C62950 Dislodged or dislocated FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62841 1575 Short fill C63144 1233 Filling problem FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62842 1568 Shielding failure Issue associated with device inability to act as a barrier for absorption of radiation energy in X-rays, gamma rays, etc. C62932 Protective measure issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62844 1557 Self-activation or keying Self-activation/keying Issue associated with the unintended activation of device, or device having been unexpectedly turned on during use. C63013 Deployment issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62845 Sediment, precipitate or deposit in device or device ingredient C62982 Device ingredient or reagent issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62846 Scratched material Scratched Issue associated with an undesirable shallow cut or narrow groove in the surface of the materials used in device construction. C62968 Material integrity issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62847 1544 Material rigid or stiff Rigid|Rigid or stiff C63248 Material deformation FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62848 1535 Incorrect or inadequate result Results incorrect Issue associated with a non-conforming end result, data, or test results provided by the device to its performance specifications. C62941 Output issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62849 1248 Restricted flowrate Flowrate, restricted C63110 Improper flow or infusion FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62850 2325 Residue after decontamination Residue Issue associated with the decontamination process not adequately removing unwanted visible soil, foreign material, or organism deposits. C63099 1091 Inadequate device cleaning FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62851 1571 Resetting of shock counters Shock counters, resetting of 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. C63158 1573 Failure to shock or properly shock 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. C62932 Protective measure issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62853 1524 Rejection C62919 2682 Patient-device incompatibility FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62854 1522 Reflux within device Reflux Issue associated with a backward or return flow. C73500 Retrograde Flow FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62855 2314 Radiofrequency interference (RFI) RFI Issue associated with the degradation of the reception of a wanted signal caused by RF disturbance. C63215 Electromagnetic compatibility issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62856 1511 Radio signal problem Radio signal problems Issue associated with the wireless transmission signal in the lowest range of the electromagnetic spectrum. C63271 Communication or transmission issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62857 1357 Radiation leak Leak, radiation C63058 1354 Leak FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62858 1508 Radiation delivered to incorrect body area C62862 2017 Improper or incorrect procedure or method FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62859 1503 Pumping stopped Pumping, stopped C62860 Pumping issue 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. C63075 Infusion or flow issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62861 2281 Prompts will not clear C62955 Device operates differently than expected FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62862 2017 Improper or incorrect procedure or method Improper or incorrect method|Method improper/incorrect|Procedure, improper/incorrect 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. C63318 1670 Incorrect care or use of device FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62863 1484 Premature deployment Premature system activation Issue associated with an early and unexpected deployment of the device and/or device components from the system. C63013 Deployment issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62864 1057 Premature discharge of battery Battery, premature discharge of C63030 Battery issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62865 Premature indicator activation C62932 Protective measure issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62866 1478 Precipitate in device or device ingredient Precipitate Issue associated with the separation of solid particles from a liquid as the result of a chemical or physical change. C62845 Sediment, precipitate or deposit in device or device ingredient FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62867 1477 Pre or post-pumping problem Pre/post-pumping problems C62860 Pumping issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62868 1474 Power conditioning issue Issue associated with inadequate power conditioning such as the presence of fluctuation, surges, spikes, dropouts, noice and other such undesirable transients. C63217 Electrical power problem FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62869 1408 Poor quality image Monitor, image quality poor Issue associated with an image or any visual representation displayed by the device with non- distinctive characteristics. C63108 Improper device output FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62870 Inadequate lighting Issue associated with an inappropriate level of light or illumination in the immediate environment in which the device is being used or stored. C63209 Environmental control or utility issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62871 1306 Image resolution poor C62869 1408 Poor quality image FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62872 1463 Pocket stimulation Issue associated with a pocket of skin in which the pulse generator is housed. C63097 1442 Pacing inadequately FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62873 1462 Plunge C62995 Failure to auto stop FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62874 1460 Pitted Pitting Issue associated with the corrosion of a material's surface, confined to a point or small area that takes the form of cavities. C62970 1153 Degraded FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62875 2578 Physical resistance Resistance, physical C63034 Advancement issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62876 1457 Perivalvular leak Leak(s), perivalvular|Paravalvular leak(s)|Paravalvular leak Issue associated with the escape of blood around a heart valve, particularly around its leaflets. C63137 1250 Fluid leak FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62878 1454 Peeled Peeling|Peeled device material 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. C62970 1153 Degraded FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62879 1451 Particulates Substances that consist of separate partiicles that are introduced by the device during use. C62845 Sediment, precipitate or deposit in device or device ingredient FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62880 1440 Pacer found in back-up mode C63169 1439 Failure to pace or properly pace FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62881 1438 Oversensing C63061 2293 Invalid sensing FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62882 1311 Excess flow or overinfusion Overinfusion|Overdelivery C63075 Infusion or flow issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62883 1437 Overheating of device or device component Overheat Issue associated with the excessive heating or high temperature beyond the tolerance level such that the properties and structure undergo severe modification. C62922 Temperature issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62884 2404 Overfill C63144 1233 Filling problem 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. C62961 1384 Mechanical issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62887 1305 Image orientation incorrect Issue associated with an incorrect image orientation on the device display. C63108 Improper device output FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62888 Optical obstruction Issue associated with the blocking of optical devices, e.g., visual pathways. C62953 Optical issue 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. C62953 Optical issue 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. C62953 Optical issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62891 1360 Optical decentration Lens, decentration of Issue associated with being off-center of optical lenses. C62953 Optical issue 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. C62862 2017 Improper or incorrect procedure or method 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. C63270 Computer operating system issue 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. C63270 Computer operating system issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62895 1426 Material opacification Opacification|Opaque Issue associated with an undesirable opaqueness or cloudiness. C62968 Material integrity issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62896 1423 Occlusion within device Occlusion|Plugged Issue associated with obstruction, closure or blockage of device opening, pipe, tube or another narrow comprising part. C62897 2423 Obstruction within device FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62897 2423 Obstruction within device Obstruction C63075 Infusion or flow issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62898 1420 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. C62948 1506 Product quality issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62899 2282 No voice prompts Prompts, no voice C63094 2280 Inappropriate prompts FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62900 1435 No device output Output, none Issue associated with no measurement outcome, value, or data obtained from the device. C62941 Output issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62901 1382 Missing device markings Markings, none|No markings on device C62939 Packaging issue 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. C63075 Infusion or flow issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62903 No fail-safe mechanism C62997 Fail-safe mechanism issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62904 1183 No display or display failure Display, failure to Issue associated with the absence of visual indicator. C62900 1435 No device output 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. C62970 1153 Degraded FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62907 Mushroomed C63248 Material deformation FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62908 1385 Melted Material molten|Melts Issue associated with the evidence of material softening, resulting in a nonreversible change. C63248 Material deformation FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62909 Moisture or humidity problem Issue associated with an unsatisfactory humidity level in the environment in which the device is being used or stored. C63209 Environmental control or utility issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62910 1405 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. C62909 Moisture or humidity problem FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62911 2531 Missing device label Labeling, missing C62939 Packaging issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62912 Instruction missing Missing device instruction 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. C62939 Packaging issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62913 1401 Misfocusing C62891 1360 Optical decentration FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62914 2532 Misfire Issue associated with device and/or device components' inability to create a blasting charge to explode when expected. C62961 1384 Mechanical issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62915 1399 Misconnection Improper connection Issue associated with the connection of device and/or device components being improper or not in accordance with device specification, requirements and intended uses. C62952 Connection issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62916 1473 Power calculation error due to software problem Power, miscalculation of C63081 1495 Incorrect programming calculations FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62917 1395 Migration of device or device component Migration Issue associated with an undesired movement of device and/or device components, related to its movement away from or dislodging from a source. C62814 Unintended movement FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62918 1804 Metal shedding debris Debris, metal shedding C63018 1120 Contamination during use FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62919 2682 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. C62983 Incompatibility problem FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62921 2589 Tipover Device tipover C63043 2616 Malposition of device 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. C62937 Physical property issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62923 2506 Structural problem Structural failure Issue associated with the basic physical construction or physical make up of the device. C62961 1384 Mechanical issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62924 1599 Device stops intermittently Issue associated with any deviation from device document specification relating to the irregular rate at which the device stops. C62955 Device operates differently than expected FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62925 1570 Shipping damage or problem C63015 2284 Device damaged prior to use FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62926 1567 Shelf life exceeded Issue associated with the using a device after the marked or known shelf life. C62998 1216 Device expiration issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62927 Device setting does not match patient condition Issue associated with mismatch between the default or most obvious device setting and the patient anatomical and/or physiological characteristics (e.g. adult device on pediatric patient). C63118 Human factors issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62928 1563 Failure to service Service, failure to Issue associated with the lack of periodic preventive maintenance or performance assurance checks. C62977 1379 Device maintenance issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62929 1536 Retraction problem Retract, failure to Issue associated with drawing back the device and/or device component to an intended location. C62961 1384 Mechanical issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62931 1525 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. C62988 Failure to shut off 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. C62954 Device operational issue 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. C62862 2017 Improper or incorrect procedure or method 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. C63075 Infusion or flow issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62935 Polarity switch Device 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. C63007 1198 Electrical issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62937 Physical property issue Device 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. C62996 2379 Device Issue 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. C63041 Manufacturing or shipping issue associated with device FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62940 2312 Incomplete or missing packaging Packaging, incomplete/missing C63240 Device packaging compromised 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. C62954 Device operational issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62942 Output below specifications C63108 Improper device output FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62943 1432 Output above specifications C63108 Improper device output FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62944 2311 Out-of-box failure C62948 1506 Product quality issue 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. C62937 Physical property issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62946 1527 Device or device fragments remain in patient Issue associated with the inability to retrieve device and/or device fragments during medical procedures. C62955 Device operates differently than expected FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62947 1583 Size incorrect for patient Size, incorrect C62919 2682 Patient-device incompatibility FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62948 1506 Product quality issue Device or device component quality issue|Quality, unsatisfactory or poor Issue associated with an inherited device and/or device component characteristic that may not be satisfactory as specified. C63041 Manufacturing or shipping issue associated with device FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62949 1669 Failure to unfold or unwrap Difficult 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. C63248 Material deformation FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62950 Dislodged or dislocated Dislocated|Dislodged Issue associated with mechanical force that displaces device and/or device components from an intended location. C62961 1384 Mechanical issue 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. C62961 1384 Mechanical issue 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. C62954 Device operational issue 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. C62937 Physical property issue 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. C62996 2379 Device Issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62955 Device operates differently than expected Issue associated with any deviations from expected performance while operating and using the device. C63118 Human factors issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62956 1402 Product mislabeled Mislabeled Issue associated with the misbranding or false labeling of an operating system, product, or device. C63041 Manufacturing or shipping issue associated with device FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62957 Device misassembled during manufacturing or shipping C63041 Manufacturing or shipping issue associated with device FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62958 1398 Misassembled by users Misassembly Issue associated with the use of the device characterized by users' incorrect assembly of device components, parts or constituents. C62862 2017 Improper or incorrect procedure or method FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62959 1397 Misapplied device Misapplication C62862 2017 Improper or incorrect procedure or method 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. C62961 1384 Mechanical issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62961 1384 Mechanical issue Mechanical failure Issue associated with any deviations from device documented performance specifications relating to mechanical defects, including moving parts or subassemblies, etc. C62937 Physical property issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62962 Material twisted Twisting C63248 Material deformation FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62963 2537 Split Material split|Splitting 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. C62968 Material integrity issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62964 1562 Material separation Separation|Separates Issue associated with an undesired disassociation or breaking apart of materials used in device construction. C62968 Material integrity issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62965 1546 Material rupture Rupture Issue associated with the breaking or tearing apart of a material. C62967 2205 Material perforation FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62966 1504 Material puncture Puncture Issue associated with the comprising material(s) being penetrated, pierced or punctured, especially with a sharp or pointed object. C62967 2205 Material perforation FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62967 2205 Material perforation Perforation Issue associated with an undesired material damage characterized by closely spaced punched or drilled holes. C62968 Material integrity issue 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. C62937 Physical property issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62969 1261 Material fragmentation 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. C62973 1069 Break FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62970 1153 Degraded Material degradation Issue associated with a deleterious change in the chemical structure, physical properties, or appearance in the materials that are used in device construction. C62968 Material integrity issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62971 1135 Crack Crack(s)|Material 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. C62968 Material integrity issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62972 1074 Burst Material burst Issue associated with an undesired open breakage in the materials that are used in device construction. C62968 Material integrity issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62973 1069 Break Material break|Device breakage Issue associated with undesired damage or breakage of those materials used in device construction. C62968 Material integrity 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. C62976 Device markings issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62975 1381 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. C62976 Device markings issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62976 Device markings issue C63319 Labeling or Instruction for use issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62977 1379 Device maintenance issue Maintain, failure to Issue associated with the servicing of a device. C62808 Facilities issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62978 Maintenance does not comply to manufacturers recommendations Maintenance not 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. C62977 1379 Device maintenance issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62979 1663 Device inoperable 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. C63007 1198 Electrical issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62981 2426 High pH pH, high C62982 Device ingredient or reagent issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62982 Device ingredient or reagent issue C62945 Chemical issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62983 Incompatibility problem Compatibility 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. C62954 Device operational issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62984 1247 Device flammable Flammable C62922 Temperature issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62985 2308 Inadequate filtration process Filtration process, inadequate C62986 Filtration issue 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. C63075 Infusion or flow issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62987 1683 Failure to zero Zero, failure to C62852 Reset issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62988 Failure to shut off C63005 Electronic property 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. C62997 Fail-safe mechanism issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62990 1466 Failure to run on portable mode Portable mode, failure to run on C63030 Battery issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62991 1532 Failure to reset Reset, failure to C62852 Reset issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62992 1476 Failure to power-up Power-up, failure to C63025 Power source issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62993 1081 Failure to capture Capture, failure to Issue associated with the failure to achieve effective and consistent depolarization of the heart resulting from the electrical stimulus of the pacemaker. C63027 Capturing issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62994 2440 Failure to calibrate Calibrate, failure to Issue associated with the performance of the device to assure it complies with the appropriate specifications for precision and conforms to device standards. C63028 Calibration issue 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. C62932 Protective measure issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62996 2379 Device Issue Device failure|Malfunction C54034 Reportable Event FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62997 Fail-safe mechanism issue C62932 Protective measure issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62998 1216 Device expiration issue Expiration date exceeded Issue associated with the expiration date or shelf life of a product. C62808 Facilities issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C62999 2528 Expiration date error Issue associated with errors in identification of expiration date. C62998 1216 Device expiration issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63000 1210 Energy spectrum incorrect C63002 1431 Output energy incorrect FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63001 1209 Energy output to patient tissue incorrect C63002 1431 Output energy incorrect FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63002 1431 Output energy incorrect C63108 Improper device output FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63003 1585 Smoking Smoke Issue associated with a cloud of vapor or gas generated from the device, generally associated after a fire or a burn. C62922 Temperature issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63004 1425 Device emits odor C62945 Chemical issue 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. C62937 Physical property issue 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. C63007 1198 Electrical issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63007 1198 Electrical issue Device electrical issue|Electrical failure 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. C62954 Device operational issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63008 Device disinfection or sterilization issue C63099 1091 Inadequate device cleaning FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63009 Difficult to use or set up Issue associated with user experiencing difficulty in setting up, preparing and/or using the device. C63118 Human factors issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63010 1487 Device difficult to prepare Prep, difficult to 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. C63009 Difficult to use or set up 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. C63009 Difficult to use or set up 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. C62954 Device operational issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63014 1421 Delivered as unsterile product Nonsterility 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. C63019 Item contaminated during manufacturing or shipping FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63015 2284 Device damaged prior to use Damage, internal/external|Item damaged prior to use|Damaged item C63041 Manufacturing or shipping issue associated with device FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63016 2317 Device contamination with blood or blood product Blood contaminated device C63017 Device Contamination with biological material FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63017 Device Contamination with biological material C63018 1120 Contamination during use FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63018 1120 Contamination during use Contamination Issue associated with the undesired introduction of impurities either chemical or microbiological in nature, or of foreign matter into or onto the device at the user facility. C63276 Cleaning disinfecting or sterilization problem during device use 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. C63041 Manufacturing or shipping issue associated with device 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. C62983 Incompatibility problem FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63021 2306 Component missing Components, 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. C63041 Manufacturing or shipping issue associated with device FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63022 1108 Component incompatible Component(s), incompatible C63020 Component or accessory incompatibility FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63023 2292 Defective component Components, defective Issue associated with a device component having flaws of dimensional deviations greater than acceptable for the intended use. C63250 2588 Defective item FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63024 1094 Device clogged Clogged C62896 1423 Occlusion within device FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63025 Power source issue C63007 1198 Electrical issue 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. C63025 Power source issue 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. C63007 1198 Electrical issue 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. C62954 Device operational issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63030 Battery issue C63025 Power source issue 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. C62852 Reset issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63032 1031 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. C63009 Difficult to use or set up FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63033 1012 Device alarm system issue Alarm, failure to|Alarm failure 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. C62932 Protective measure issue 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. C62961 1384 Mechanical issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63035 2577 Difficult or delayed activation Activation, difficult /delayed|Activation, difficult or delayed C63244 1157 Difficult to deploy FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63036 1004 Accessory incompatible Accessories, incompatible C63020 Component or accessory incompatibility FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63037 1387 Device abrasion from instrument or another object Abrasion from instrument/object C62846 Scratched material FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63038 2590 Device or device fragments location unknown Device/device fragments, unknown location of C62950 Dislodged or dislocated 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. C62961 1384 Mechanical issue 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. C62983 Incompatibility problem 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. C62937 Physical property issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63042 Application security issue Computer virus infection 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. C63259 Unauthorized access to computer system FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63043 2616 Malposition of device Malposition Issue associated with device rotation in the pocket or is riding to high or low. C62950 Dislodged or dislocated FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63044 2575 Low threshold Threshold, low C63061 2293 Invalid sensing FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63045 2458 Low test results Test results, low C62829 2456 Incorrect or inadequate test results FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63046 2460 Low readings Readings, low C62848 1535 Incorrect or inadequate result FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63047 2285 Low impedance Impedance, low Issue associated with a lower than intended total opposition that a circuit presents to the flow of an alternating current. C63114 Impedance issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63048 2584 Low battery Battery, low C63030 Battery issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63049 1016 Low audible alarm Alarm, low audible C63112 Improper alarm FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63050 1633 Loss of threshold Threshold, loss of Issue associated with the loss of the minimum amount of energy, voltage, or current needed to consistently stimulate the heart muscle. C63061 2293 Invalid sensing FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63051 1534 Loss of resistance Resistance, loss of C63006 Electrical resistance issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63052 1475 Loss of power Power, loss of Issue associated with the failure of primary power supplied by the facility. C63217 Electrical power problem FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63053 2408 Loss of osseointegration Osseointegration, loss of C62886 Osseointegration issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63054 1043 Loss of augmentation Augmentation, loss of C62955 Device operates differently than expected FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63055 1371 Loose connection Connection(s), loose C62952 Connection issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63056 1370 Looping C63039 Mechanical jam FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63057 Light interference C62953 Optical issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63058 1354 Leak Leak(s) 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. C62961 1384 Mechanical issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63059 1340 Knotted Knot|Knotted material C62962 Material twisted FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63060 1339 Kinked Kink|Kinked material C63296 1059 Bent FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63061 2293 Invalid sensing Sensing, invalid 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. C63238 Device sensing issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63063 1336 Material invagination Invagination C63248 Material deformation FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63064 2287 Intermittent shock Shock, intermittent 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. C63158 1573 Failure to shock or properly shock FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63065 1558 Sensing intermittently C63061 2293 Invalid sensing FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63066 1443 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. C63169 1439 Failure to pace or properly pace FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63067 2341 Intermittent infusion Infusion, intermittent C63110 Improper flow or infusion FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63068 1121 Intermittent continuity Continuity, intermittent C63277 1089 Circuit Failure FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63069 1080 Intermittent capture Capture, intermittent Issue associated with the ineffective and inconsistent depolarization of the heart. C63027 Capturing issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63070 1287 Insufficient heating Heating, inadequate 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. C62922 Temperature issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63071 1130 Insufficient cooling Cooling, inadequate 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. C62922 Temperature issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63072 1318 Instruction for use issue Instructions, inadequate 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. C63319 Labeling or Instruction for use issue 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. C63072 1318 Instruction for use issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63074 Installation-related problem Installation error Issue associated with unsatisfactory initial installation, configuration, and/or setup of a specific device or technology. C62808 Facilities issue 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. C62954 Device operational issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63076 1310 Inflation issue Inflation difficulties Issue associated with the inability of device and/or device components to expand or enlarge with gas or air. C63075 Infusion or flow issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63077 1501 Increased pump speed Pump speed, increased C62860 Pumping issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63078 2535 Increased sensitivity Sensitivity, increased C63061 2293 Invalid sensing FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63079 1604 Increase in suction Aspiration, excessive|Excessive aspiration|Suction, increase in C62833 2170 Suction issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63080 1491 Increase in pressure Pressure, increase in C62934 Pressure issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63081 1495 Incorrect programming calculations Programming calculations, incorrect C62839 Programming issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63082 1494 Incorrect product Product, incorrect C62862 2017 Improper or incorrect procedure or method FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63083 1449 Parameter calculation error due to software problem Parameter calculations, incorrect C63081 1495 Incorrect programming calculations 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. C63041 Manufacturing or shipping issue associated with device FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63085 1383 Incorrect measurement Measurements, inaccurate C62848 1535 Incorrect or inadequate result FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63086 1543 Incorrect interpretation of rhythm Rhythm, incorrect interpretation of C63061 2293 Invalid sensing FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63087 1319 Incorrect instruction for device use Instructions, incorrect 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. C63072 1318 Instruction for use issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63088 1184 Incorrect display Display, incorrect Issue associated with device failure and malfunction when device does not display adequate results or have proper display. C63108 Improper device output 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. C63072 1318 Instruction for use issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63090 2507 Incomplete cooptation Issue associated with the heart valve leaflet not closing properly. C62923 2506 Structural problem FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63092 2283 Inaudible voice prompts Prompts, inaudible voice C63094 2280 Inappropriate prompts FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63093 1574 Inappropriate shock Shock, inappropriate Issue associated with the inappropriate occurrence of a short duration of a high force at the initial part of an impact. C63158 1573 Failure to shock or properly shock FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63094 2280 Inappropriate prompts Prompts, inappropriate C63108 Improper device output FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63095 1600 Inadequate storage Storage, inadequate|Storage inadequate Issue associated with inadequate or inappropriate storage of the device, not otherwise described. C62808 Facilities issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63096 1533 Inadequate resistance Resistance, inadequate C63006 Electrical resistance issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63097 1442 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. C63169 1439 Failure to pace or properly pace FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63098 1564 Inadequate service Service, inadequate Issue associated with inadequate periodic preventive maintenance or performance assurance checks. C62977 1379 Device maintenance issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63099 1091 Inadequate device cleaning Clean, failure to|Cleaning, inadequate 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. C63276 Cleaning disinfecting or sterilization problem during device use 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. C63305 Application program issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63101 1609 Inaccurate synchronization Synchronization, inaccurate Issue associated with an error due to imperfect timing of two operations; this may or may not include signal transmission time. C63169 1439 Failure to pace or properly pace FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63102 1249 Inaccurate flowrate Flowrate, inaccurate C63110 Improper flow or infusion FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63103 Inaccurate dispensing C63104 2339 Inaccurate delivery FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63104 2339 Inaccurate delivery Delivery, inaccurate C63110 Improper flow or infusion FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63105 1337 Inability to irrigate Irrigate, inability to C62902 No flow FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63106 1044 Inability to autofill Autofill, unable to C63144 1233 Filling problem FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63107 2309 Improper device rinsing Rinsing, improper C63099 1091 Inadequate device cleaning 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. C62941 Output issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63109 1266 Improper gas output Gas output, improper C63108 Improper device output 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. C63075 Infusion or flow issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63111 Improper chemical reaction Issue associated with inappropriate mixing of chemicals. C62945 Chemical issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63112 Improper alarm C63033 1012 Device alarm system issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63113 1307 Imprecision C62994 2440 Failure to calibrate 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. C63005 Electronic property issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63115 1358 Image reversal C62887 1305 Image orientation incorrect FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63117 1304 Image display error C63088 1184 Incorrect display 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. C62996 2379 Device Issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63119 1298 Hot oil leak C63137 1250 Fluid leak FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63120 1293 Hole in material Hole|Hole(s) Issue associated with an opening not characteristic of the normal material. C62967 2205 Material perforation FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63121 2574 High threshold Threshold, high C63061 2293 Invalid sensing FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63122 2457 High test results Test results, high C62829 2456 Incorrect or inadequate test results FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63123 2459 High Readings Readings, high C62848 1535 Incorrect or inadequate result FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63124 1291 High impedance Impedance, high Issue associated with a higher than intended total opposition that a circuit presents to the flow of an alternating current. C63114 Impedance issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63125 1271 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. C63007 1198 Electrical issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63126 1270 Gradient increase Issue associated with the increased rate of change in temperature, pressure, or other variables as a function of distance, time, etc. C63110 Improper flow or infusion 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. C63058 1354 Leak FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63128 2316 Fungus in device environment Fungus Issue associated with the visibility of molds, mildews, yeasts, and/or mushrooms in the immediate environment in which a device is being used. C63292 Biological environmental factor FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63129 2529 Fumes or vapors Fumes/vapors Issue associated with the visibility, odor, or toxicity of an ambient vapor or gas which affects the operation of the device. C62807 Ventilation issue in device environment 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. C63110 Improper flow or infusion FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63131 1262 Material frayed Frayed Issue associated with the comprising materials having damaged edges. C63248 Material deformation FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63132 1260 Fracture Fracture(s) of device/material Issue associated with any mechanical discontinuity in the material; it therefore is the collective term for joints, faults, cracks, etc. C62973 1069 Break FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63133 Foreign material present in device Foreign material Issue associated with the presence of materials, which are not part of the documented device specifications and requirements. C63018 1120 Contamination during use FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63134 2630 Folded Fold C63296 1059 Bent FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63135 1253 Fogging Issue associated with the visibility of water vapor in the immediate atmosphere in which the device is being used. C62807 Ventilation issue in device environment FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63136 2619 Increased fluid or volume Fluid/volume, increased C62955 Device operates differently than expected FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63137 1250 Fluid leak Fluid leak(s) C63058 1354 Leak FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63138 1634 Tidal volume fluctuations Issue associated with the amount of gas that is inspired and expired during one respiratory cycle. C63110 Improper flow or infusion FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63139 Flashpoint threshold met Issue associated with approaching certain temperatures at which a combustible liquid ignites. C62945 Chemical issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63140 Flare or flash Issue associated with device-related burn with an unsteady flame. C62922 Temperature issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63141 1246 Flaked Flaked material|Flaking Issue associated with the detachment of small pieces of the coating film of a material. C62970 1153 Degraded FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63142 2183 Fitting problem Fitting problems 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. C62952 Connection issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63143 1245 Fire Issue associated with destructive burning or combustion of inflammable materials as manifested by any or all of the following: light, flame, heat, smoke. C62922 Temperature issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63144 1233 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. C63075 Infusion or flow issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63145 1228 False reading from device non-compliance False readings Issue associated with the non-compliance of the device to meet its specific performance characteristics thereby causing a false reading. C62848 1535 Incorrect or inadequate result FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63147 1227 False positive result False-positive test result Issue associated with the device incorrectly reporting that something has been detected and misleads the operator to take certain actions. C62848 1535 Incorrect or inadequate result FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63149 1225 False negative result False-negative test 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. C62848 1535 Incorrect or inadequate result FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63150 1226 False device output False output C63108 Improper device output FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63151 1224 False claim in device label False claim 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. C63319 Labeling or Instruction for use issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63152 1013 False alarm Alarm, false Issue associated with device providing incorrect alarm warning or alert to user. C63033 1012 Device alarm system issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63153 1105 Component falling Component(s) 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. C62950 Dislodged or dislocated FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63154 Failure to unwrap Unwrap, failure to Issue associated with problems removing the materials used to construct the cover or outer wrapping of the device. C63231 Difficult to open or remove packaging material FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63155 1521 Failure to transmit record Record, failure to transmit C63271 Communication or transmission issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63156 1596 Failure to sterilize Sterilization failure|Sterilization, inadequate C63008 Device disinfection or sterilization issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63157 2536 Failure to spike Spike, failure to 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. C63169 1439 Failure to pace or properly pace FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63158 1573 Failure to shock or properly shock Shock, failure to deliver 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. C63007 1198 Electrical issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63159 2547 Failure to separate Separate, failure to 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. C63013 Deployment issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63160 1559 Failure to sense Sensing, none 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. C63238 Device sensing issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63161 1582 Failure to select signal Signal, failure to select C63061 2293 Invalid sensing FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63162 1001 Failure to run on AC/DC AC/DC, failure to run on C62992 1476 Failure to power-up FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63163 1213 Failure to remove enzymatic cleaner Enzymatic cleaner, failure to remove C63107 2309 Improper device rinsing FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63164 1581 Failure to read input signal Input signal, failure to read C63271 Communication or transmission issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63165 1502 Failure to pump Pump, failure to C62860 Pumping issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63166 1497 Failure to program Program, failure to C62862 2017 Improper or incorrect procedure or method FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63167 1492 Failure to prime Prime, failure to C62955 Device operates differently than expected FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63168 1488 Failure to prepare device Prep, failure to Issue associated with the use of device characterized by unsuccessful attempts to make the device ready for use. C62862 2017 Improper or incorrect procedure or method FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63169 1439 Failure to pace or properly pace Pace, failure to 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. C63007 1198 Electrical issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63170 1542 Failure to override rhythm Rhythm, failure to override C63169 1439 Failure to pace or properly pace FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63171 1863 Failure to osseointegrate Osseointegrate, failure to 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. C62886 Osseointegration issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63172 2533 Failure to obtain samples Samples, failure to obtain C62955 Device operates differently than expected FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63173 1332 Failure to interrogate Interrogate, failure to 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. C63007 1198 Electrical issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63174 2340 Failure to infuse Infuse, failure to C62902 No flow FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63175 1255 Failure to fold Fold, failure to C63248 Material deformation FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63176 1252 Failure to flush Flush, failure to C63107 2309 Improper device rinsing FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63177 2610 Failure to fire Fire, failure to C62955 Device operates differently than expected FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63178 1192 Failure to dry Dry, failure to C62862 2017 Improper or incorrect procedure or method FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63179 1175 Failure to disinfect Disinfect, failure to|Disinfection, inadequate/improper C63008 Device disinfection or sterilization issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63180 2541 Failure to disconnect Disconnect, failure to 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. C62952 Connection issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63181 1169 Failure to discharge Discharge, failure to 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. C63158 1573 Failure to shock or properly shock FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63183 1158 Failure to deploy Deploy, failure to Issue associated with the inability of device and/or device components to be activated and positioned in a specified location. C63013 Deployment issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63184 1211 Failure to deliver energy Energy, failure to deliver C63002 1431 Output energy incorrect FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63185 1133 Failure to deliver countershock Countershock, failure to deliver|Failure to countershock Issues associated with the effective electromotive force within a system that fails to oppose the passage of current in a specified direction. C63158 1573 Failure to shock or properly shock FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63186 2338 Failure to deliver Deliver, failure to C62902 No flow FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63187 1142 Failure to cycle Cycle, failure to Issue associated with the occurrence of total time used to carry out a complete sequence of operations fails. C62960 Mechanics altered FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63188 2587 Failure to cut Cut, failure to C62960 Mechanics altered FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63189 1048 Failure to convert to back-up Back-up, failure to convert to C63258 Data back-up problem FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63190 1540 Failure to convert rhythm Rhythm, failure to convert C63169 1439 Failure to pace or properly pace FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63191 1114 Failure to conduct Conduct, failure to 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. C63007 1198 Electrical issue 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. C63158 1573 Failure to shock or properly shock FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63193 1085 Failure to charge Charge, failure to Issue associated with failure to register charge immediately after charging in relation to the apparent surface voltage present on an electrostatic recording medium. C63026 Charging issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63194 1068 Loss of or failure to bond Bond, failure to 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. C62973 1069 Break FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63195 1047 Failure to back-up Back-up, failure to Issue associated with the inability to backup or to retrieve a backed up version (corrupted file) of device data or system files. C63258 Data back-up problem FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63196 1539 Failure to analyze rhythm Failure to diagnose rhythm|Rhythm, failure to analyze|Rhythm, failure to diagnose C63061 2293 Invalid sensing FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63197 2522 Failure to align Align, failure to Issue associated with a circuit, equipment, or system whereby its functions fail to be properly synchronized or its relative positions properly oriented. C62960 Mechanics altered FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63198 2524 Failure to advance Advance, failure to Issue associated with the inability to see a forward movement of the device and/or device components to an intended location. C63034 Advancement issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63199 1222 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. C62997 Fail-safe mechanism issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63200 2629 Exit block Issue associated with the identification of a conduction delay or failure immediately distal to a pacemaker site. C63169 1439 Failure to pace or properly pace FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63201 2527 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. C62862 2017 Improper or incorrect procedure or method 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. C62922 Temperature issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63204 Escape C62950 Dislodged or dislocated FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63205 2591 Error message given Issue associated with device providing messages relating to any deviations from documented performance specifications in software, hardware, and/or user interface. C62955 Device operates differently than expected FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63206 Incorrect error code C63305 Application program issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63207 1182 Erratic display Display, erratic C63088 1184 Incorrect display FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63208 1214 Material erosion 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. C62970 1153 Degraded 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. C62808 Facilities issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63210 1212 Entrapment of device or device component Entrapment Issue associated with the device and/or device accessories caught within patient vasculature or tissue. C63034 Advancement issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63212 1205 Emergency power failure Issue associated with the failure of the facility's emergency power backup systems(s) including generators and/or uninterruptible power systems (UPS). C63217 Electrical power problem FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63213 2149 Electro-static discharge Issue associated with the discharge of electricity between two bodies previously electrically charged. C63215 Electromagnetic compatibility issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63214 1194 Electro-magnetic interference (EMI) EMI Issue associated with a measure of electromagnetic radiation from equipment. C63215 Electromagnetic compatibility issue 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. C63005 Electronic property issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63216 Electrical shorting C63277 1089 Circuit Failure FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63217 Electrical power problem Issue associated with the facility-supplied 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. C63209 Environmental control or utility issue 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. C63005 Electronic property issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63219 2407 Dull C62948 1506 Product quality issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63220 1189 Dose calculation error due to software problem Dose calculation error C63081 1495 Incorrect programming calculations FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63221 1181 Display misread Issue associated with not correctly reading the patient or test result information provided by the device. C62848 1535 Incorrect or inadequate result FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63222 1177 Material disintegration Disintegrate 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. C62968 Material integrity issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63223 1171 Disconnection Broken Connection|Disconnect 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. C62952 Connection issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63224 1170 Material discolored 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. C62968 Material integrity issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63225 1168 Disassembly C63242 Detachment of device or device component FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63226 1680 Difficult to wedge Wedge, difficult to 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. C63009 Difficult to use or set up FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63228 1528 Difficult to remove Removal difficulties 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. C63009 Difficult to use or set up FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63230 1467 Difficult to position Positioning difficulties 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. C63009 Difficult to use or set up 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. C62939 Packaging issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63232 1331 Difficult to interrogate Interrogate, difficult to Issue associated with difficulty of a transponder system to trigger a response. C63173 1332 Failure to interrogate FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63233 1316 Difficult to insert Insertion difficulties 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. C63009 Difficult to use or set up FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63234 1254 Difficult to fold or unfold Fold, difficult to 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. C63009 Difficult to use or set up 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. C63034 Advancement issue 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. C62983 Incompatibility problem 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. C63007 1198 Electrical issue 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. C62939 Packaging issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63241 1517 Failure to recalibrate Recalibrate, failure to C62994 2440 Failure to calibrate FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63242 Detachment of device or device component Device or device component detached Issue associated with the separation of the device and/or device components from its physical construct, integrity, or chassis. C62961 1384 Mechanical issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63243 1104 Detachment of device component Component(s), detachment of|Device component detached C63242 Detachment of device or device component FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63244 1157 Difficult to deploy Deploy, difficult to Issue associated with users experiencing difficulty or uneasiness to deploy device and/or device components to a specified location. C63013 Deployment issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63245 2526 Dent in material Dent C63248 Material deformation FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63246 Delivery system failure C62961 1384 Mechanical issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63247 1011 Delayed alarm Alarm, delayed C63112 Improper alarm 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. C62968 Material integrity issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63249 1149 Deflation issue Deflation difficulties Issue associated with the inability of device and/or device components to release gas or air. C63075 Infusion or flow issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63250 2588 Defective item Device, defective Issue associated with having flaws or dimensional deviations greater than acceptable for the intended use of the device. C63041 Manufacturing or shipping issue associated with device FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63251 1014 Defective Alarm Alarm, defective C63112 Improper alarm FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63252 1500 Decreased pump speed Pump speed, decreased C62860 Pumping issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63253 2534 Decreased sensitivity Sensitivity, decreased C63061 2293 Invalid sensing FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63254 1146 Decrease in suction Aspiration, incomplete|Incomplete aspiration|Suction, decrease in Issue associated with the removal by suction of excess fluid or gas from a body cavity. C62833 2170 Suction issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63255 1490 Decrease in pressure Pressure, decrease in C62934 Pressure issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63256 1145 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. C62952 Connection issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63257 Data corrupted C63305 Application program issue 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. C63269 1112 Computer software issue 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. C64348 Computer system security issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63260 2454 Cut in material Cut|Cut(s) C62967 2205 Material perforation FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63261 1137 Cross reactivity Issue associated with the degree to which an antibody or antigen participates in cross reactions. C62845 Sediment, precipitate or deposit in device or device ingredient FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63263 1131 Corrosion Corrode|Corroded 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. C62970 1153 Degraded FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63264 1126 Incorrect control settings Control settings incorrect 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. C62862 2017 Improper or incorrect procedure or method FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63265 1123 Continuous firing Issue associated with the excessive production of electrical impulses over a period. C63007 1198 Electrical issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63266 Ingredient or reagent contamination Contamination of device ingredient or reagent C63018 1120 Contamination during use 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. C63072 1318 Instruction for use issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63269 1112 Computer software issue Computer software error 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. C62954 Device operational issue 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. C63269 1112 Computer software issue 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. C62937 Physical property issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63272 1099 Collapse Issue associated with the buckling or crushing of material from external forces. C62923 2506 Structural problem FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63273 1098 Coiled C62962 Material twisted FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63274 1096 Coagulation in device or device ingredient Coagulation Issue associated with the undesired characterization of congealing, solidifying, thickening, curdling. C62845 Sediment, precipitate or deposit in device or device ingredient FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63275 1095 Clumping in device or device ingredient Clumping Issue associated with the aggregation of particles, such as bacteria, into irregular masses. C62845 Sediment, precipitate or deposit in device or device ingredient 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. C62808 Facilities issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63277 1089 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. C63005 Electronic property issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63278 Chemical spillage Issue associated with unintentional pouring out or releasing of chemical substances. C62945 Chemical issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63279 1086 Charred C63286 1071 Burn of device or device component FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63280 2586 Delayed charge time Charge times, delayed C63026 Charging issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63281 2288 Aborted charge Charge, aborted Issue associated with the spontaneous ending of the charging process in relation to the apparent surface voltage present on an electrostatic recording medium. C63026 Charging issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63282 1027 Changes in ambient temperature in device environment Ambient temperature, changes in C63307 Ambient temperature issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63283 1079 Capacitive coupling C63277 1089 Circuit Failure FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63284 1078 Calibration error Miscalibration C62994 2440 Failure to calibrate FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63285 1077 Calcified Calcification|Calcified material Issue associated with the gradual decrease in the efficiency of the device comprising material(s) impregnated with calcium salts and deposition of calcareous material. C62970 1153 Degraded FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63286 1071 Burn of device or device component Burn|Burned|Burnt 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.) C62922 Temperature issue 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. C62968 Material integrity issue 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. C62952 Connection issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63289 1065 Blockage within device or device component Blockage C62896 1423 Occlusion within device FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63290 1064 Bleed back C63110 Improper flow or infusion FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63292 Biological environmental factor C63209 Environmental control or utility issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63293 1062 Biofilm coating in device Biofilm coating C63297 2303 Bacterial contamination of device FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63294 Biocompatibility issue C62982 Device ingredient or reagent issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63296 1059 Bent Bend material|Bent Material Issue associated with the change in angle of a material as a function of steadily applied forces. C62962 Material twisted FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63297 2303 Bacterial contamination of device Bacterial contamination|Contamination, bacterial C63017 Device Contamination with biological material FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63298 1441 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. C63169 1439 Failure to pace or properly pace FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63299 Aspiration issue C62833 2170 Suction issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63300 1036 Artifact Issue associated when an extrinsic agent, method or image produces any item (display, suspension etc) that is not naturally present. C62829 2456 Incorrect or inadequate test results FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63301 2583 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. C63005 Electronic property issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63302 1032 Arcing at paddles C63301 2583 Arcing FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63303 2289 Arcing at electrodes C63301 2583 Arcing FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63304 Application program version or upgrade problem C63305 Application program issue 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. C63269 1112 Computer software issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63306 1138 Application interface becomes non-functional or program exits abnormally Crash or lock-up C63305 Application program issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63307 Ambient temperature issue Issue associated with the thermal state in the immediate environment in which a device is being used. C63209 Environmental control or utility issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63308 Ambient noise issue Issue associated with any undesired acoustic energy or vibration that tends to interfere with the operation of the device. C63209 Environmental control or utility issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63309 1022 Alarm not visible C63112 Improper alarm FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63310 1019 Not audible alarm Alarm, not audible C63112 Improper alarm FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63311 1008 Air leak Air leak(s) C63127 Gas leak FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63312 1591 Accidental spillage Spillage, accidental Issue associated with the unexpected flowing or pouring of liquids, gas or air substances into the device or environment in which the device is being used. C62862 2017 Improper or incorrect procedure or method FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63315 1483 Premature elective replacement indicator Premature ERI C62865 Premature indicator activation FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63316 1267 Gel leak Gel leakage C63058 1354 Leak FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63317 1251 Difficult to flush Flush, difficult to C63009 Difficult to use or set up FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63318 1670 Incorrect care or use of device Device, incorrect care/use of Issue associated with user's faiilure to process, serive, or operate the device according to the manufacturer's recommendations or recognized best practices. C63118 Human factors issue 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. C63118 Human factors issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C63320 1480 Premature end-of-life indicator Premature EOL C62865 Premature indicator activation FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C64243 No Pressure C62934 Pressure issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C64328 2579 Failure to form staple C62960 Mechanics altered FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C64334 Battery impedance issue C63030 Battery issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C64335 Low battery impedance C64334 Battery impedance issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C64336 High battery impedance C64334 Battery impedance issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C64339 1496 Difficult to program Program, difficult to C63009 Difficult to use or set up FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C64340 Material torqued Torqued Issue associated with a movement of forces that produces or tends to produce rotation or torsion of a material C62962 Material twisted FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C64341 Device or device component incrementation issue C63034 Advancement issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C64343 No code available C48655 Missing Value Reason FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C64348 Computer system security issue C63269 1112 Computer software issue 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. C63269 1112 Computer software issue 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. C63305 Application program issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C67508 2582 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. C63269 1112 Computer software issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C72671 Lack of Maintenance Documentation or Guidelines Issue associated with user facility not receiving adequate service documentation, guidelines, or recommendations to perform preventive and corrective maintenance and performance assurance checks. C62977 1379 Device maintenance issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C72674 Environmental 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. C63209 Environmental control or utility issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C72887 Medical Gas Supply Problem Issue associated with the facility-supplied medical gases such as medical air, oxygen, nitrous oxide, and nitrogen. C63209 Environmental control or utility issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C72890 Overcorrection Issue associated with an adjustment that surpasses a set criterion. C63028 Calibration issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C72891 Material Protrusion Issue associated with undesired physical appearance of device material, specifically when material extends beyond or above the device surface. C62968 Material integrity issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C72892 Radiation overexposure Issue associated with excessive radiation emitted from radiological or diagnostic device. C62943 1432 Output above specifications FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C72893 Radiation Underexposure Issue associated with too little radiation emitted from radiological or diagnostic devices. Results in insufficient production of normal image contrast. C62942 Output below specifications FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C72894 Material Distortion Issue associated with undesired physical appearance of device material resulting from excessive stress or impact. C62968 Material integrity issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C73117 1643 Inadequate training Issue associate with facility not providing satisfactory initial and/or periodic user training covering operation of the device. C62808 Facilities issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C73118 Device Unsafe to Use in Environment C63209 Environmental control or utility issue FDA C54451 Medical_Device_Problem_Codes_FDA_CDRH C73500 Retrograde Flow C63110 Improper flow or infusion FDA C54450 Patient_Problem_Codes_FDA_CDRH C2849 1782 Congenital Defect/Deformity Deformity/defect, congenital|Defect/deformity, congenital Any abnormality, anatomical or biochemical, evident at birth or during the neonatal period. C36287 Congenital or Acquired Anatomic Abnormality FDA C54450 Patient_Problem_Codes_FDA_CDRH C2851 1684 AIDS, Acquired Immunodeficiency Syndrome Acquired immunodeficiency syndrome, AIDS A syndrome resulting from the acquired deficiency of cellular immunity caused by the human immunodeficiency virus (HIV). It is characterized by the reduction of the Helper T-lymphocytes in the peripheral blood and the lymph nodes. Symptoms include generalized lymphadenopathy, fever, weight loss, and chronic diarrhea. Patients with AIDS are especially susceptible to opportunistic infections (usually pneumocystis carinii pneumonia, cytomegalovirus (CMV) infections, tuberculosis, candida infections, and cryptococcosis), and the development of malignant neoplasms (usually non-Hodgkin's lymphoma and Kaposi's sarcoma). The human immunodeficiency virus is transmitted through sexual contact, sharing of contaminated needles, or transfusion of contaminated blood. -- 2004 C27145 T-Cell Immunodeficiency FDA C54450 Patient_Problem_Codes_FDA_CDRH C2867 1958 Memory Loss Loss of memory Systematic and extensive loss of memory caused by organic or psychological factors. The loss may be temporary or permanent, and may involve old or recent memories. C3858 Mental and Behavioral Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C2869 1706 Anemia A reduction in the number of red blood cells per cu mm, the amount of hemoglobin in 100 ml of blood, and the volume of packed red blood cells per 100 ml of blood. Clinically, anemia represents a reduction in the oxygen-transporting capacity of a designated volume of blood, resulting from an imbalance between blood loss (through hemorrhage or hemolysis) and blood production. Signs and symptoms of anemia may include pallor of the skin and mucous membranes, shortness of breath, palpitations of the heart, soft systolic murmurs, lethargy, and fatigability. C26324 Non-Neoplastic Hematologic and Lymphocytic Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C2876 1711 Anoxia Absence or reduction of oxygen in body tissue. (PSY94) C3890 1918 Hypoxia FDA C54450 Patient_Problem_Codes_FDA_CDRH C2881 1721 Arrhythmia Any variation from the normal rate or rhythm (which may include the origin of the impulse and/or its subsequent propagation) in the heart. C35741 Non-Neoplastic Heart Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C2883 1723 Arthritis Inflammation of a joint or a state characterized by inflammation of joints. C35760 2373 Joint Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C2884 1724 Arthritis, Rheumatoid Rheumatoid Arthritis A chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures, widespread fibrinoid degeneration of the collagen fibers in mesenchymal tissues, and by atrophy and rarefaction of bony structures. Etiology is unknown, but autoimmune mechanisms have been implicated. C2883 1723 Arthritis FDA C54450 Patient_Problem_Codes_FDA_CDRH C2885 2596 Ascites Accumulation of fluid in the peritoneal cavity. The fluid may be serous, hemorrhagic, or the result of tumor metastasis to the peritoneum. -- 2004 C26848 Peritoneal Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C2889 1732 Autoimmune Disease Disease, autoimmune A disorder resulting from loss of function or tissue destruction of an organ or multiple organs, arising from humoral or cellular immune responses of the individual to his own tissue constituents. It may be systemic (e.g., systemic lupus erythematosus), or organ specific, (e.g., thyroiditis). -- 2003 C3507 Immune System Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C2890 1735 Infection, Bacterial Bacterial infection C26726 1930 Infection FDA C54450 Patient_Problem_Codes_FDA_CDRH C2902 1779 Coagulopathy A condition in which there is a deviation from or interruption of the normal coagulation properties of the blood. C26324 Non-Neoplastic Hematologic and Lymphocytic Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C2910 2438 Breast Neoplasm Neoplasm, breast A benign or malignant neoplasm of the breast parenchyma. It can originate from the ducts, lobules or the breast adipose tissue. Breast neoplasms are much more common in females than males. -- 2003 C26709 Breast Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C2911 1752 Bronchitis C27557 Non-Neoplastic Lung Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C2962 2063 Seizures Convulsion Sudden, involuntary skeletal muscular contractions of cerebral or brain stem origin.--2004 C3837 Neurological Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C2980 1815 Dysphagia C3368 Gastrointestinal System Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C2982 2361 Depression A mental state of depressed mood characterised by feelings of sadness, despair and discouragement. C2893 Psychiatric Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C2983 2443 Skin Inflammation Inflammation of skin C27554 Dermatosis FDA C54450 Patient_Problem_Codes_FDA_CDRH C2987 1811 Diarrhea A condition of frequent and watery bowel movements. C5034 Disturbance in Bowel Function FDA C54450 Patient_Problem_Codes_FDA_CDRH C2992 1813 Disseminated intravascular coagulation (DIC) Coagulation (DIC), disseminated intravascular|DIC|Intravascular coagulation (DIC), disseminated|Disseminated intravascular coagulation|DIC, disseminated intravascular coagulation A disorder characterized by reduction in the elements involved in blood coagulation due to their utilization in widespread blood clotting within the vessels. A pathological process in the body where the blood starts to coagulate throughout the whole body. This depletes the body of its platelets and coagulation factors, and there is an increased the risk of hemorrhage. C2902 1779 Coagulopathy FDA C54450 Patient_Problem_Codes_FDA_CDRH C2998 1816 Dyspnea Breathing Difficulties|Difficulty breathing C3676 Alteration in Respiration FDA C54450 Patient_Problem_Codes_FDA_CDRH C2999 Dysuria Difficulty or pain in urination. Difficulty or pain in urination. C5035 Genitourinary Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C3002 1820 Edema Accumulation of an excessive amount of watery fluid in cells or intercellular tissues. C3399 2091 Swelling FDA C54450 Patient_Problem_Codes_FDA_CDRH C3036 1849 Fatigue That state, following a period of mental or bodily activity, characterized by a lessened capacity for work and reduced efficiency of accomplishment, usually accompanied by a feeling of weariness, sleepiness, or irritability. C3858 Mental and Behavioral Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C3038 1858 Fever The elevation of the body's temperature above the upper limit of normal, usually taken as 37.7 degrees C. C7941 Alteration in Body Temperature FDA C54450 Patient_Problem_Codes_FDA_CDRH C3044 1861 Fibrosis The formation of fibrous tissue; fibroid or fibrous degeneration. The formation of fibrous tissue; fibroid or fibrous degeneration. C35867 Morphologic Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C3045 1862 Fistula C36287 Congenital or Acquired Anatomic Abnormality FDA C54450 Patient_Problem_Codes_FDA_CDRH C3046 1870 Fracture(s) A traumatic injury to the bone in which the continuity of the bone is broken. - 2003 C35487 Bone Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C3064 1876 Granuloma C35867 Morphologic Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C3080 1783 Congestive Heart Failure Failure, congestive heart|Heart failure, congestive 1. inadequacy of the heart so that as a pump it fails to maintain the circulation of blood, with the result that congestion and edema develop in the tissues; SEE ALSO forward heart failure, backward heart failure, right ventricular failure, left ventricular failure. SYN cardiac failure, cardiac insufficiency, congestive heart failure, myocardial insufficiency. 2. resulting clinical syndromes including shortness of breath, pitting edema, enlarged tender liver, engorged neck veins, and pulmonary rales in various combinations. C35741 Non-Neoplastic Heart Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C3090 2558 Hematuria Blood in the urine. C35457 Abnormal Urine Test Result FDA C54450 Patient_Problem_Codes_FDA_CDRH C3094 1887 Hemoptysis Coughing up blood from the respiratory tract. C4876 Symptom FDA C54450 Patient_Problem_Codes_FDA_CDRH C3095 1897 Hepatitis Inflammation of the liver; usually from a viral infection, but sometimes from toxic agents. C53550 Non-Neoplastic Hepatic Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C3109 2153 Hot Flashes Flashes, hot C7941 Alteration in Body Temperature FDA C54450 Patient_Problem_Codes_FDA_CDRH C3113 1906 Hyperplasia An abnormal increase in the number of cells in an organ or a tissue with consequent enlargement. C2991 Disease or Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C3114 1907 Hypersensitivity Allergic Reaction 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. 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. C3507 Immune System Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C3117 1908 Hypertension Blood Pressure, High|Increased blood pressure|Pressure, high blood|High blood pressure|Blood Pressure, Increased Pathological increase in blood pressure; a repeatedly elevated blood pressure exceeding 140 over 90 mmHg. C54707 Blood Pressure Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C3126 1912 Hypoglycemia Blood Glucose, Low|Glucose, low blood|Low blood glucose Abnormally low level of glucose in the blood. C35553 Abnormal Blood Chemistry and Hematology Test Result FDA C54450 Patient_Problem_Codes_FDA_CDRH C3128 1914 Hypotension Blood Pressure, Decreased|Low blood pressure|Pressure, low blood|Decreased blood pressure|Blood Pressure, Low Any blood pressure that is below the normal expected for an individual in a given environment. C54707 Blood Pressure Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C3131 2156 Immuno-Deficiency A deficiency of immune response or a disorder characterized by deficient immune response. Syndromes in which there is a deficiency or defect in the mechanisms of immunity, either cellular or humoral. C3507 Immune System Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C3133 1925 Impotence C3347 Sexual Dysfunction FDA C54450 Patient_Problem_Codes_FDA_CDRH C3137 1932 Inflammation A localized protective response resulting from injury or destruction of tissues. Inflammation serves to destroy, dilute, or wall off both the injurious agent and the injured tissue. In the acute phase, inflammation is characterized by the signs of pain, heat, redness, swelling, and loss of function. Histologically, inflammation involves a complex series of events, including dilatation of arterioles, capillaries, and venules, with increased permeability and blood flow; exudation of fluids, including plasma proteins; and leukocyte migration into the site of inflammation. --2004 C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C3143 2187 Jaundice C3368 Gastrointestinal System Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C3197 2439 Breast Lumps Lumps, breast A mass in the mammary gland, either mobile or immobile. Once the mass has reached the size of a small garden pea, it can be detected by palpation. With mammography a larger number of early breast cancers are being detected since this techniques allows detection prior to the point at which the mass can be felt. Breast masses are not always malignant. Benign fibrocystic breast disease is not uncommon. A fine needle biopsy aspiration can distinguish a cystic mass from a solid one. C34808 Mass FDA C54450 Patient_Problem_Codes_FDA_CDRH C3199 2237 Chronic obstructive pulmonary disease, (COPD) Disease (COPD), chronic obstructive|Pulmonary disease (COPD), chronic obstructive|Obstructive pulmonary disease (COPD), chronic|COPD, chronic obstructive pulmonary disease C27557 Non-Neoplastic Lung Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C3245 2419 Infection, Fungal Fungal infection An infection caused by eukaryotic heterotrophic organisms that live as saprobes or parasites, including mushrooms, yeasts, smuts, molds, etc. They reproduce either sexually or asexually, and have life cycles that range from simple to complex. Filamentous fungi refer to those that grow as multicellular colonies (mushrooms and molds). C26726 1930 Infection FDA C54450 Patient_Problem_Codes_FDA_CDRH C3258 1970 Nausea The sensation that one is about to vomit. C3259 Nausea and Vomiting FDA C54450 Patient_Problem_Codes_FDA_CDRH C3284 2422 Obstruction C36291 Finding by Cause FDA C54450 Patient_Problem_Codes_FDA_CDRH C3303 1994 Pain The sensation of discomfort, distress, or agony, resulting from the stimulation of specialized nerve endings. C4876 Symptom FDA C54450 Patient_Problem_Codes_FDA_CDRH C3310 1997 Paralysis C5039 Motor Manifestations FDA C54450 Patient_Problem_Codes_FDA_CDRH C3327 2074 Skin Discoloration Discoloration of skin A change from the patient's baseline skin coloration. C36281 Integumentary System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C3331 2010 Pleural Effusion Effusion, pleural Increased amounts of fluid within the pleural cavity containing no malignant cells C3003 Effusion FDA C54450 Patient_Problem_Codes_FDA_CDRH C3333 2011 Pneumonia An acute, acute and chronic, or chronic inflammation focally or diffusely affecting the lung parenchyma, due to infections (viruses, fungi, mycoplasma, or bacteria), treatment (e.g. radiation), or exposure (inhalation) to chemicals. Symptoms include cough, shortness of breath, fevers, chills, chest pain, headache, sweating, and weakness. C27557 Non-Neoplastic Lung Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C3344 1943 Itching An intense itching sensation. C5036 Integumentary System Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C3348 1832 Emphysema, Pulmonary Pulmonary emphysema 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. A subcategory of chronic obstructive pulmonary disease (COPD). It occurs in people who smoke and suffer from chronic bronchitis. It is characterized by inflation of the alveoli, alveolar wall damage, and reduction in the number of alveoli, resulting in difficulty breathing. C3199 2237 Chronic obstructive pulmonary disease, (COPD) FDA C54450 Patient_Problem_Codes_FDA_CDRH C3349 2255 Radiodermatitis A cutaneous inflammatory reaction occurring as a result of exposure to biologically effective levels of ionizing radiation. A cutaneous inflammatory reaction occurring as a result of exposure to biologically effective levels of ionizing radiation. C2983 2443 Skin Inflammation FDA C54450 Patient_Problem_Codes_FDA_CDRH C3353 1696 Adult Respiratory Distress Syndrome ARDS|Adult respiratory distress syndrome, ARDS Progressive and life-threatening pulmonary distress in the absence of an underlying pulmonary condition, usually following major trauma or surgery. Cases of neonatal respiratory distress syndrome are not included in this definition. C27561 Respiratory Distress Syndrome FDA C54450 Patient_Problem_Codes_FDA_CDRH C3364 2067 Sepsis C27583 Infectious Disorder by Site FDA C54450 Patient_Problem_Codes_FDA_CDRH C3365 2071 Venereal Disease Disease (VD), venereal|VD|Venereal disease (VD)|VD, venereal disease Any contagious disease acquired during sexual contact; e.g. syphilis, gonorrhea, chancroid. A disorder acquired through sexual contact. --2004 C26726 1930 Infection FDA C54450 Patient_Problem_Codes_FDA_CDRH C3376 2517 Sleep Disturbances Disturbances, sleep A change from the patient's baseline sleeping pattern, either an increase or a decrease in the number of hours slept. This can also refer to alterations in the stages of sleep. C2893 Psychiatric Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C3390 1770 Cerebrovascular Accident CVA|Cerebrovascular accident, (CVA)|Stroke|Syndrome, stroke|Stroke Syndrome|CVA, Cerebrovascular accident A sudden, nonconvulsive loss of neurologic function due to an ischemic or hemorrhagic intracranial vascular event. In general, cerebrovascular accidents are classified by anatomic location in the brain, vascular distribution, etiology, age of the affected individual, and hemorrhagic vs. nonhemorrhagic nature. (From Adams et al., Principles of Neurology, 6th ed, pp777-810) C2938 Cerebrovascular Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C3399 2091 Swelling Enlargement; expansion in size; sign of inflammation C4876 Symptom FDA C54450 Patient_Problem_Codes_FDA_CDRH C3426 2274 Ulcer C3671 2348 Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C3429 1928 Incontinence C5035 Genitourinary Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C3432 2278 Urticaria Hives Urticaria. An itchy skin eruption characterized by weals with pale interiors and well-defined red margins; usually the result of an allergic response to insect bites or food or drugs. C2983 2443 Skin Inflammation FDA C54450 Patient_Problem_Codes_FDA_CDRH C3439 2248 Infection, Viral Viral infection Any disease caused by a virus. C26726 1930 Infection FDA C54450 Patient_Problem_Codes_FDA_CDRH C3442 2144 Vomiting The reflex act of ejecting the contents of the stomach through the mouth. C3259 Nausea and Vomiting FDA C54450 Patient_Problem_Codes_FDA_CDRH C3508 2442 Reaction, Injection Site Injection site reaction An intense reaction (usually immunologic) developing at the site of injection C16956 Pathologic Process FDA C54450 Patient_Problem_Codes_FDA_CDRH C3671 2348 Injury Damage inflicted on the body as the direct or indirect result of an external force, with or without disruption of structural continuity. C36291 Finding by Cause FDA C54450 Patient_Problem_Codes_FDA_CDRH C3672 1758 Calcification Deposit(s), calcium|Calcium Deposit(s) Deposition of calcium in the tissues. It may be the result of a metabolic disorder or long-standing infection, or it may be associated with the presence of cancer. -- 2004 C9442 1809 Deposits FDA C54450 Patient_Problem_Codes_FDA_CDRH C3832 2359 Malaise C4876 Symptom FDA C54450 Patient_Problem_Codes_FDA_CDRH C3889 2000 Pelvic Inflammatory Disease Disease (PID), pelvic inflammatory|Pelvic inflammatory disease, (PID)|Inflammatory disease (PID), pelvic|PID, pelvic inflammatory diseasec|PID Any pelvic infection involving the upper female genital tract beyond the cervix. Pelvic inflammatory disease (PID) is an acute or chronic inflammation in the pelvic cavity. It is most commonly caused by sexually transmitted diseases, including chlamydia and gonorrhea, that have ascended into the uterus, fallopian tubes, or ovaries as a result of intercourse or childbirth, or of surgical procedures, including insertion of IUDs or abortion. PID may be either symptomatic or asymptomatic. It may cause infertility and it may raise the risk of ectopic pregnancy. PID is a disease associated with HIV infection. C27612 Female Non-Neoplastic Reproductive System Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C3890 1918 Hypoxia C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C4080 2001 Perforation A hole or opening made through a membrane or other tissue or material. C3671 2348 Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C4376 2041 Renal failure Failure, renal Acute or chronic condition, characterized by the inability of the kidneys to adequately filter the blood substances, resulting in uremia and electrolyte imbalances. Acute renal failure is usually associated with oliguria or anuria, hyperkalemia, and pulmonary edema. Chronic renal failure is irreversible and requires hemodialysis.--2004 C27600 Non-Neoplastic Renal Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C4731 1983 Neuropathy A disorder affecting the cranial nerves or the peripheral nervous system. It is manifested with pain, tingling, numbness, and muscle weakness. It may be the result of physical injury, toxic substances, viral diseases, diabetes, renal failure, cancer, and drugs. -- 2004 C27580 Peripheral Nervous System Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C4786 1808 Dementia C4802 Neurodegenerative Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C4872 1759 Cancer, Breast Breast cancer C2916 Carcinoma FDA C54450 Patient_Problem_Codes_FDA_CDRH C7941 Alteration in Body Temperature C4876 Symptom FDA C54450 Patient_Problem_Codes_FDA_CDRH C9439 2039 Renal Disease, End Stage Disease (ESRD), end stage renal|Renal disease (ESRD), end stage|End stage renal disease (ESRD)|ESRD|ESRD, end stage renal disease Chronic, irreversible renal failure. An irreversible and usually progressive reduction in renal function in which both kidneys have been damaged by a variety of diseases to the extent that they are unable to adequately remove the metabolic products from the blood and regulate the body's electrolyte composition and acid-base balance. (from MSH98) C9438 Chronic Renal Failure FDA C54450 Patient_Problem_Codes_FDA_CDRH C9442 1809 Deposits Accumulation of extraneous inorganic matter in tissues or cavities. C35867 Morphologic Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C9445 2208 Rupture Forcible tearing or disruption of tissue. C3671 2348 Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C14196 2220 Cytomegalovirus (CVM) CMV, cytomegalovirus A genus of the family herpesviridae, subfamily betaherpesvirinae, infecting the salivary glands, liver, spleen, lungs, eyes, and other organs, in which they produce characteristically enlarged cells with intranuclear inclusions. C14217 Herpesvirus FDA C54450 Patient_Problem_Codes_FDA_CDRH C14209 1872 Fungus A kingdom of eukaryotic, heterotrophic organisms that live as saprobes or parasites, including mushrooms, yeasts, smuts, molds, etc. They reproduce either sexually or asexually, and have life cycles that range from simple to complex. Filamentous fungi refer to those that grow as multicellular colonies (mushrooms and molds). C25796 Eukaryota FDA C54450 Patient_Problem_Codes_FDA_CDRH C14219 2197 HIV, Human Immunodeficiency Virus Human immunodeficiency virus (HIV)|Virus (HIV), human immunodeficiency A cytopathic retrovirus. It is the etiological agent of AIDS. The virus isolated and recognized as the etiologic agent of AIDS. HIV-1 is classified as a lentivirus, a subtype of retroviruses. C14290 Lentivirus FDA C54450 Patient_Problem_Codes_FDA_CDRH C14283 2136 Virus A term for a group of infectious agents which with few exceptions are capable of passing through fine filters that retain most bacteria, are usually not visible through the light microscope, lack independent metabolism, and are incapable of growth or reproduction apart from living cells. C14250 Organism FDA C54450 Patient_Problem_Codes_FDA_CDRH C15179 1702 Amputation The surgical removal of all or part of a limb or other appendage. C49165 Surgical Procedure by Method FDA C54450 Patient_Problem_Codes_FDA_CDRH C15191 1719 Apheresis C15657 Blood Treatment FDA C54450 Patient_Problem_Codes_FDA_CDRH C15192 2337 Transfusion Of Blood Products Blood products, transfusion of The injection of whole blood or a blood component directly into the bloodstream. C15657 Blood Treatment FDA C54450 Patient_Problem_Codes_FDA_CDRH C15211 2552 Colostomy The surgical creation of an opening between the colon and the surface of the body. (MeSH) C15210 Colon and Rectal Surgery FDA C54450 Patient_Problem_Codes_FDA_CDRH C15248 1885 Hemodialysis C15221 Dialysis FDA C54450 Patient_Problem_Codes_FDA_CDRH C15266 2366 Laparotomy Creation of a surgical opening into the abdominal cavity. C16120 Abdominal Surgical Procedure FDA C54450 Patient_Problem_Codes_FDA_CDRH C15329 2357 Surgical Procedure Procedure, surgical A diagnostic or treatment procedure performed by manual and/or instrumental means, often involving an incision and the removal or replacement of a diseased organ or tissue; of or relating to or involving or used in surgery or requiring or amenable to treatment by surgery. C25218 Intervention or Procedure FDA C54450 Patient_Problem_Codes_FDA_CDRH C15341 2393 Tracheostomy Creation of a surgical opening into the trachea. C15454 Head and Neck Surgery FDA C54450 Patient_Problem_Codes_FDA_CDRH C15986 2571 Treatment With Medication(s) Medication(s), treatment with Treatment of disease through the use of drugs. C21090 Pharmacologic Management FDA C54450 Patient_Problem_Codes_FDA_CDRH C16313 1733 Autoimmune reaction Reaction, autoimmune Developmentally complex, not necessarily pathological, and possibly pervasive, an Autoimmune Process is a specific humoral or cell-mediated immune response against autologous (self) antigens. An autoimmune process may produce or be caused by autoimmune disease. C16956 Pathologic Process FDA C54450 Patient_Problem_Codes_FDA_CDRH C16897 1971 Necrosis The pathologic localized death of living cells, as from infection or interruption of the blood supply, generally associated with severe cellular trauma caused by progressive degradation by enzymes. Characterized by mitochondrial swelling, nuclear flocculation, and uncontrolled cell lysis, it is unprogrammed death of living tissue and cells. C41515 Cell Death Process FDA C54450 Patient_Problem_Codes_FDA_CDRH C16900 1978 Neovascularization Growth of new blood vessels feeding a tissue, as with a tumor. C16956 Pathologic Process FDA C54450 Patient_Problem_Codes_FDA_CDRH C17000 2009 Pleomorphism Having different forms at different stages of the life cycle. C19896 Miscellaneous Molecular Biology Terms FDA C54450 Patient_Problem_Codes_FDA_CDRH C17998 Unknown Unknown|Unknown (For Use When The Patients Condition Is Not Known)|Unknown (for use when the device problem is not known) Not known, not observed, not recorded, or refused. C27993 General Qualifier FDA C54450 Patient_Problem_Codes_FDA_CDRH C21007 2371 Disability Any physical, mental, or functional impairment that limits a major activity. It may be partial or complete. (Taber's) C16669 Health Status FDA C54450 Patient_Problem_Codes_FDA_CDRH C21097 2368 Sedation The process of allaying nervous excitement or the state of being calmed. (Taber's) C15181 Anesthesia Procedure FDA C54450 Patient_Problem_Codes_FDA_CDRH C25637 2414 Reaction A response generated by a stimulus. C20189 Property or Attribute FDA C54450 Patient_Problem_Codes_FDA_CDRH C25754 1931 Infiltration of tissue Infiltration|Infiltrates To penetrate a tissue or substance. The process of the diffusion or accumulation in a tissue or cells of a substance not normal to it or in amounts above normal. (NCI) C19986 Biophysical Process FDA C54450 Patient_Problem_Codes_FDA_CDRH C25757 2116 Ulceration The formation or development of an ulcer. C16956 Pathologic Process FDA C54450 Patient_Problem_Codes_FDA_CDRH C26682 1685 Pain, Abdominal Abdominal pain C3303 1994 Pain FDA C54450 Patient_Problem_Codes_FDA_CDRH C26686 1690 Abscess C2890 1735 Infection, Bacterial FDA C54450 Patient_Problem_Codes_FDA_CDRH C26693 1708 Aneurysm C35552 Cardiovascular System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C26696 2328 Anxiety Apprehension of danger and dread accompanied by restlessness, tension, tachycardia, and dyspnea unattached to a clearly identifiable stimulus. C3858 Mental and Behavioral Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C26698 1720 Apnea Arrest, respiratory|Respiratory Arrest Cessation of breathing. Transient cessation of respiration. C3676 Alteration in Respiration FDA C54450 Patient_Problem_Codes_FDA_CDRH C26710 2437 Bronchopneumonia C3333 2011 Pneumonia FDA C54450 Patient_Problem_Codes_FDA_CDRH C26713 1766 Cataract Partial or complete opacity of the crystalline lens of one or both eyes that decreases visual acuity and eventually results in blindness. Some cataracts appear in infancy or in childhood, but most develop in older individuals. (Diagnostic Surgical Pathology, 3rd ed.) C26812 Lens Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C26715 1768 Cellulitis C2890 1735 Infection, Bacterial FDA C54450 Patient_Problem_Codes_FDA_CDRH C26720 1777 Chorioamnionitis C27583 Infectious Disorder by Site FDA C54450 Patient_Problem_Codes_FDA_CDRH C26726 1930 Infection A disorder resulting from the presence and activity of a microbial, viral, or parasitic agent. It can be transmitted by direct or indirect contact. -- 2003 C53547 Non-Neoplastic Disorder by Special Category FDA C54450 Patient_Problem_Codes_FDA_CDRH C26729 1786 Connective Tissue Disease Disease, connective tissue|Tissue disease, connective C27574 Connective and Soft Tissue Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C26730 1789 Corneal Abrasion C35392 Corneal Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C26737 1798 Cyanosis C4876 Symptom FDA C54450 Patient_Problem_Codes_FDA_CDRH C26740 1807 Dehydrated C5044 Fluid and Electrolyte Manifestation FDA C54450 Patient_Problem_Codes_FDA_CDRH C26744 2253 Dermatomyositis C2889 1732 Autoimmune Disease FDA C54450 Patient_Problem_Codes_FDA_CDRH C26746 2062 Scleroderma C2889 1732 Autoimmune Disease FDA C54450 Patient_Problem_Codes_FDA_CDRH C26750 2374 Joint Dislocation Dislocated joint C35724 Dislocation FDA C54450 Patient_Problem_Codes_FDA_CDRH C26758 1818 Ecchymosis C26791 1888 Hemorrhage FDA C54450 Patient_Problem_Codes_FDA_CDRH C26759 1829 Embolism C35740 Non-Neoplastic Vascular Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C26760 2429 Encephalitis C27586 Non-Neoplastic Central Nervous System Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C26769 1846 Facial Nerve Paralysis Paralysis of facial nerve|Nerve paralysis, facial C26941 Cranial Nerve Paralysis FDA C54450 Patient_Problem_Codes_FDA_CDRH C26780 1874 Gastritis Inflammation of the stomach. C53501 Non-Neoplastic Stomach Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C26782 1875 Glaucoma Increased pressure in the eyeball due to obstruction of the outflow of aqueous humor. C27604 Non-Neoplastic Eye Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C26791 1888 Hemorrhage Bleeding The flow of blood from a ruptured blood vessel. C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C26794 2349 Fracture, Hip Hip fracture C27002 Lower Extremity Fracture FDA C54450 Patient_Problem_Codes_FDA_CDRH C26797 1905 Hyperglycemia Blood Glucose, High|Glucose, high blood|High blood glucose A high level of blood sugar. It is usually an indication of diabetes mellitus. --2003 C35553 Abnormal Blood Chemistry and Hematology Test Result FDA C54450 Patient_Problem_Codes_FDA_CDRH C26805 1944 Keratitis Inflammation of the cornea. C27608 Non-Neoplastic Corneal Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C26828 2389 Meningitis C27586 Non-Neoplastic Central Nervous System Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C26849 2252 Peritonitis C27666 Non-Neoplastic Peritoneal Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C26851 2367 Pharyngitis C27661 Non-Neoplastic Pharyngeal Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C26868 2020 Pulmonary Edema Edema, pulmonary C27043 Acute Respiratory Failure FDA C54450 Patient_Problem_Codes_FDA_CDRH C26872 2484 Respiratory failure Failure, respiratory C27557 Non-Neoplastic Lung Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C26874 2047 Detached retina Retina, detached C26967 Retinal Detachment and Defect FDA C54450 Patient_Problem_Codes_FDA_CDRH C26883 2073 Sjogren's Syndrome Syndrome, sjogren's C2889 1732 Autoimmune Disease FDA C54450 Patient_Problem_Codes_FDA_CDRH C26891 2100 Thrombosis C35740 Non-Neoplastic Vascular Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C26901 1840 Erythema C3327 2074 Skin Discoloration FDA C54450 Patient_Problem_Codes_FDA_CDRH C26906 2275 Urinary Frequency Frequency, urinary urination at short intervals; it may result from increased urine formation, decreased bladder capacity, or lower urinary tract irritation. C5035 Genitourinary Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C26909 2122 Uveitis C35776 Non-Neoplastic Uveal Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C26920 1833 Encephalopathy C27586 Non-Neoplastic Central Nervous System Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C26925 1992 Polymyositis C27578 Myositis FDA C54450 Patient_Problem_Codes_FDA_CDRH C27009 2238 Myalgia C3303 1994 Pain FDA C54450 Patient_Problem_Codes_FDA_CDRH C27061 2362 Peroneal Nerve Palsy Nerve palsy, peroneal|Palsy, peroneal nerve Paralysis of the nerves located in the legs. Paralysis of the nerves located in the legs. C27587 Non-Neoplastic Peripheral Nervous System Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C27083 2101 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. An aggregation of blood factors, primarily platelets and fibrin with entrapment of cellular elements, frequently causing vascular obstruction at the point of its formation. C35552 Cardiovascular System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C27088 1903 Hyperbilirubinemia Excessive concentrations of bilirubin in the blood, which may lead to jaundice. Abnormally high level of bilirubin in the blood. Excess bilirubin is associated with jaundice. C35553 Abnormal Blood Chemistry and Hematology Test Result FDA C54450 Patient_Problem_Codes_FDA_CDRH C27123 2137 Blurred vision Vision, Blurring Of|Blurring Blurred vision is the loss of visual acuity (sharpness of vision) resulting in a loss of ability to see small details. (from MedlinePlus Medical Encyclopedia) C5042 Visual Manifestations FDA C54450 Patient_Problem_Codes_FDA_CDRH C27153 1956 Lupus C2889 1732 Autoimmune Disease FDA C54450 Patient_Problem_Codes_FDA_CDRH C27165 2045 Respiratory Distress Distress, respiratory C5043 Ventilation or Perfusion Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C27298 2620 Ptosis C36287 Congenital or Acquired Anatomic Abnormality FDA C54450 Patient_Problem_Codes_FDA_CDRH C27560 2046 Respiratory Distress Syndrome Of Newborns Syndrome of newborns (RDS), respiratory distress|Newborns (RDS), respiratory distress syndrome of|RDS, respiratory distress syndrome of newborns|Respiratory distress syndrome of newborns (RDS)|RDS 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. 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. C27562 Hyaline Membrane Syndrome FDA C54450 Patient_Problem_Codes_FDA_CDRH C27644 1801 Deafness C35731 1882 Hearing loss FDA C54450 Patient_Problem_Codes_FDA_CDRH C27783 2351 Fracture, Arm C27782 Upper Extremity Fracture FDA C54450 Patient_Problem_Codes_FDA_CDRH C27990 2333 Toxicity The finding of bodily harm due to the poisonous effects of something. C3671 2348 Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C27996 1969 Myocardial Infarction Infarction (MI), myocardial|Myocardial infarction, (MI)|MI, myocardial infarction|MI Gross necrosis of the myocardium, as a result of interruption of the blood supply to the area, as in coronary thrombosis. Gross necrosis of the myocardium, as a result of interruption of the blood supply to the area, as in coronary thrombosis. C35544 Myocardial Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C28195 2654 Thromboembolism C26759 1829 Embolism FDA C54450 Patient_Problem_Codes_FDA_CDRH C28221 2129 Venipuncture Technique used to draw blood from a vein for diagnostic purposes or for treatment of certain blood disorders. (From MSH 2002) C18020 Diagnostic Procedure FDA C54450 Patient_Problem_Codes_FDA_CDRH C28245 1725 Aspiration To draw in with the breath through the nose. C20181 Conceptual Entity FDA C54450 Patient_Problem_Codes_FDA_CDRH C28397 1726 Asthma A chronic respiratory disease manifested as difficulty breathing due to the narrowing of bronchial passageways. C27557 Non-Neoplastic Lung Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C34331 2543 Abdominal Cramps Cramps, abdominal C34827 2193 Cramp(s) FDA C54450 Patient_Problem_Codes_FDA_CDRH C34336 1962 Miscarriage Loss of the products of conception from the uterus before the fetus is viable; spontaneous abortion. Expulsion of the products of conception before the completion of gestation without deliberate interference. C35221 1688 Abortion FDA C54450 Patient_Problem_Codes_FDA_CDRH C34338 2216 Abortion, Therapeutic C35221 1688 Abortion FDA C54450 Patient_Problem_Codes_FDA_CDRH C34376 2279 Hemolytic Anemia Anemia, hemolytic C35142 Normocytic Anemia FDA C54450 Patient_Problem_Codes_FDA_CDRH C34398 1722 Arteriosclerosis C35317 Arterial Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C34439 2598 Bronchospasm C27557 Non-Neoplastic Lung Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C34441 1757 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. C3671 2348 Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C34442 2549 Caustic/Chemical Burns Burn, caustic/chemical|Chemical/caustic burn C34441 1757 Burn(s) FDA C54450 Patient_Problem_Codes_FDA_CDRH C34455 2228 Clouding, Central Corneal Corneal clouding, central|Central corneal clouding Diffuse edema of the central region of the cornea, usually associated with the wearing of hard contact lenses, but may also occur in keratoconus. C36283 Eye and Ear Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C34483 2061 Scarring A mark left (usually on the skin) by the healing of injured tissue. C3044 1861 Fibrosis FDA C54450 Patient_Problem_Codes_FDA_CDRH C34497 2417 Coma Comatose C36280 Nervous System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C34504 1784 Conjunctivitis Conjunctivitis; inflammation of the conjunctiva of the eye. C27607 Non-Neoplastic Conjunctival Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C34553 1814 Dry Eye(s) Eye(s), dry C27604 Non-Neoplastic Eye Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C34582 1834 Endocarditis Inflammation of the endocardium. C35741 Non-Neoplastic Heart Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C34586 1835 Endophthalmitis C45372 Eye Infection FDA C54450 Patient_Problem_Codes_FDA_CDRH C34602 1845 Eye injury Injury, eye C36283 Eye and Ear Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C34620 Foreign body C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C34660 1879 Head Injury Injury, head C36282 Head and Neck Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C34661 1880 Headache Pain in various parts of the head, not confined to the area of distribution of any nerve. C3837 Neurological Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C34670 1883 Heartburn C3303 1994 Pain FDA C54450 Patient_Problem_Codes_FDA_CDRH C34685 2240 Hernia C36287 Congenital or Acquired Anatomic Abnormality FDA C54450 Patient_Problem_Codes_FDA_CDRH C34738 1942 Ischemia C35552 Cardiovascular System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C34818 2665 Intermenstrual Bleeding C26791 1888 Hemorrhage FDA C54450 Patient_Problem_Codes_FDA_CDRH C34827 2193 Cramp(s) C36288 Connective and Soft Tissue Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C34830 1764 Cardiomyopathy A disease of the heart muscle or myocardium proper. Cardiomyopathies may be classified as either primary or secondary, on the basis of etiology, or on the pathophysiology of the lesion: hypertrophic, dilated, or restrictive. C35544 Myocardial Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C34831 2470 Myocarditis C35544 Myocardial Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C34851 2188 Uremia C35553 Abnormal Blood Chemistry and Hematology Test Result FDA C54450 Patient_Problem_Codes_FDA_CDRH C34857 2415 Numbness C34549 Disturbance of Skin Sensation FDA C54450 Patient_Problem_Codes_FDA_CDRH C34882 2053 Rheumatic Heart Disease Disease, rheumatic heart|Heart disease, rheumatic C35741 Non-Neoplastic Heart Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C34945 1819 Ectopic Pregnancy Pregnancy, ectopic C35169 Pregnancy Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C34979 2049 Retina, Degeneration Of Degeneration of retina C27610 Non-Neoplastic Retinal Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C35016 2072 Shock C5044 Fluid and Electrolyte Manifestation FDA C54450 Patient_Problem_Codes_FDA_CDRH C35018 2068 Shock, septic Septic shock C35016 2072 Shock FDA C54450 Patient_Problem_Codes_FDA_CDRH C35019 2267 Shock, Surgical Surgical shock C35016 2072 Shock FDA C54450 Patient_Problem_Codes_FDA_CDRH C35035 2083 Sprain C3671 2348 Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C35053 1610 Syncope Faint A spontaneous loss of consciousness caused by insufficient blood to the brain. C3837 Neurological Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C35143 2191 Chills A sensation of cold that often marks the start of an infection and the development of a fever. C7941 Alteration in Body Temperature FDA C54450 Patient_Problem_Codes_FDA_CDRH C35219 1959 Menstrual Irregularities Irregularities, menstrual Deviations from the normal process; e.g. delayed, difficult, profuse, scanty, unusual bleeding, etc. Deviations from the normal process; e.g. delayed, difficult, profuse, scanty, unusual bleeding, etc. C34815 Menstrual Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C35221 1688 Abortion Any termination of pregnancy happening before the fetus is able to sustain independent life. C34941 Pregnancy Complication FDA C54450 Patient_Problem_Codes_FDA_CDRH C35375 1797 Crushing Injury Injury, crushing C3671 2348 Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C35468 1822 Edema, macular Macular edema C27610 Non-Neoplastic Retinal Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C35481 1731 Atrial Tachycardia Any rapid heart rhythm originating in the atria. Atrial fibrillation and atrial flutter are varieties of atrial tachycardia. C35061 Supraventricular Tachycardia FDA C54450 Patient_Problem_Codes_FDA_CDRH C35498 2108 Toxic Shock Syndrome Shock syndrome (TSS), toxic|Syndrome (TSS), toxic shock|TSS, toxic shock syndrome|Toxic shock syndrome, (TSS)|TSS 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. A rare acute life-threatening systemic bacterial noncontagious illness caused by any of several related staphylococcal exotoxins. TSS characterised by high fever, hypotension, rash, multi-organ dysfunction, and cutaneous desquamation during the early convalescent period. The toxins affect the host immune system, causing an exuberant and pathological host inflammatory response. Laboratory findings consistent with TSS include leukocytosis, elevated prothrombin time, hypoalbuminemia, hypocalcemia, and pyuria. C28193 Syndrome FDA C54450 Patient_Problem_Codes_FDA_CDRH C35546 2195 Dysphasia C36280 Nervous System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C35650 2420 Infection, Upper Respiratory Tract C26873 Infectious Lung Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C35731 1882 Hearing loss Loss of hearing C3078 Hearing Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C35760 2373 Joint Disorder Disorder, joint Any disease of the joints. C26326 Non-Neoplastic Connective and Soft Tissue Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C35768 1728 Atherosclerosis C34398 1722 Arteriosclerosis FDA C54450 Patient_Problem_Codes_FDA_CDRH C36172 2444 Sweating The loss of a watery fluid, consisting mainly of sodium chloride and urea in solution, that is secreted by the sweat glands in the skin of mammals. C7941 Alteration in Body Temperature FDA C54450 Patient_Problem_Codes_FDA_CDRH C36173 2475 Prolapse C36287 Congenital or Acquired Anatomic Abnormality FDA C54450 Patient_Problem_Codes_FDA_CDRH C36290 2570 Chemical Exposure Exposure, chemical C36291 Finding by Cause FDA C54450 Patient_Problem_Codes_FDA_CDRH C37920 1751 Bradycardia Decreased heart rate|Heart Rate, Decreased An abnormally slow heartbeat; as applied in adult medicine, it is generally defined as a heart rate of under 60 beats per minute. C37254 Cardiovascular System Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C37921 1754 Bruise Injury of the soft tissues or bone without breaking the skin, as by a blow. (from Dictionary.com) C3671 2348 Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C37928 2553 Confusion/Disorientation Disorientation/confusion A mental state characterized by a lack of clear and orderly thought and behavior. C4876 Symptom FDA C54450 Patient_Problem_Codes_FDA_CDRH C37942 2329 Distress Extreme physical pain or psychological suffering. C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C37943 2194 Dizziness Dizziness is a medically indistinct term used to describe a variety of conditions such as lightheadedness, unsteadiness, giddiness, a sense of turning, spinning or rocking. C3837 Neurological Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C37965 1886 Hemolysis Disruption of the integrity of the erythrocyte membrane causing release of hemoglobin. C61553 Cytolysis FDA C54450 Patient_Problem_Codes_FDA_CDRH C37966 1899 Hiccups A diaphragmatic spasm causing a sudden inhalation which is interrupted by a spasmodic closure of the glottis, producing a noise. C3676 Alteration in Respiration FDA C54450 Patient_Problem_Codes_FDA_CDRH C37970 2242 Hypernatremia Hypernatremia; higher than normal levels of sodium in the circulating blood. C35553 Abnormal Blood Chemistry and Hematology Test Result FDA C54450 Patient_Problem_Codes_FDA_CDRH C37981 2559 Intubation The insertion of a cannula or tube into a hollow body organ. C49236 Therapeutic Procedure FDA C54450 Patient_Problem_Codes_FDA_CDRH C37999 2467 Palpitations An unpleasant sensation of irregular and/or forceful beating of the heart. C37254 Cardiovascular System Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C38003 2004 Phlebitis Phlebitis; inflammation of a vein. C35117 Vascular Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C38006 2012 Pneumothorax Pneumothorax; abnormal presence of air in the pleural cavity resulting in the collapse of the lung. C27563 Non-Neoplastic Pleural Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C38029 2095 Tachycardia Heart Rate, Increased|Increased heart rate Tachycardia; an abnormally rapid heartbeat, usually applied to a heart rate above 100 per minute. C37254 Cardiovascular System Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C38038 2515 Shaking/Tremors Tremors/shaking The shaking movement of the whole body or just a certain part of it, often caused by problems of the neurons responsible for muscle action. C5039 Motor Manifestations FDA C54450 Patient_Problem_Codes_FDA_CDRH C38057 2134 Vertigo Vertigo is a feeling of movement, a sensation as if the external world were revolving around the patient (objective vertigo) or as if he himself were revolving in space (subjective vertigo). Vertigo is medically distinct from dizziness, lightheadedness, and unsteadiness. C3837 Neurological Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C38665 1776 Chest Pain Pain in chest Pain in the chest. C3303 1994 Pain FDA C54450 Patient_Problem_Codes_FDA_CDRH C39594 2033 Rash Any change in the skin which affects its appearance or texture. A rash may be localised to one part of the body, or affect all the skin. Rashes may cause the skin to change color, itch, become warm, bumpy, dry, cracked or blistered, swell and may be painful. C5036 Integumentary System Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C39611 2668 Bowel Perforation C4080 2001 Perforation FDA C54450 Patient_Problem_Codes_FDA_CDRH C40866 2126 Vasoconstriction Vasospasm Vasoconstriction involves narrowing of a blood vessel lumen due to smooth muscle contraction in the vessel wall and leads to decreased blood flow. C35552 Cardiovascular System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C40867 2127 Vasodilatation A state of increased caliber of the blood vessels. Vasodilation involves widening of a blood vessel lumen due to smooth muscle relaxation in the vessel wall and leads to increased blood flow. C41473 Cardiovascular Alteration FDA C54450 Patient_Problem_Codes_FDA_CDRH C41330 2487 ST Segment Depression Depression, ST segment The normal ST segment of the EKG tracing begins at the isoelectric line, is typically isoelectric (flat), extending from the end of the S wave and curving gradually upward to the beginning of the T wave. Causes of ST segment depression include myocardial ischemia, digoxin effect, ventricular hypertrophy, acute posterior myocardial infarction, pulmonary embolus, left bundle branch block. C41328 Electrocardiographic Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C46088 1774 Cesarean Section (c-section) Delivery by cesarean section (c-section)|C-section (cesarean section), delivery by The delivery of an infant through a surgical abdominal incision. Surgery is performed when there may be complications associated with a vaginal birth and increased risk to the mother or fetus. 2005 C15332 Gynecological Surgical Procedure FDA C54450 Patient_Problem_Codes_FDA_CDRH C48198 1842 Extravasation A discharge or escape, as of blood, from a vessel into the tissues. The leakage of body fluid or cells from the vascular system to the surrounding tissues. This process occurs either by force or as a result of a pathologic reaction (e.g., inflammation). This process may sometimes allow cancer cells to migrate from capillaries to adjacent tissues, initiating micro-metastases. C16956 Pathologic Process FDA C54450 Patient_Problem_Codes_FDA_CDRH C50403 2452 Diaphoretic Pertaining to or characterized by, or promoting diaphoresis; an agent that produces diaphoresis. (Diaphoresis is the act of perspiration, especially profuse perspiration). Pertaining to, characterized by, or promoting sweating, e.g. procedure or an agent that promotes sweating. C20189 Property or Attribute FDA C54450 Patient_Problem_Codes_FDA_CDRH C50405 2250 Nonpyrogenic C20189 Property or Attribute FDA C54450 Patient_Problem_Codes_FDA_CDRH C50407 2117 Under No Medication Medication, not under C28104 Patient Characteristics Qualifier FDA C54450 Patient_Problem_Codes_FDA_CDRH C50408 2118 Under No Sedation Sedation, not under C28104 Patient Characteristics Qualifier FDA C54450 Patient_Problem_Codes_FDA_CDRH C50410 2218 Anaphylactoid Resembling anaphylaxis. C27992 Disease Qualifier FDA C54450 Patient_Problem_Codes_FDA_CDRH C50412 2560 Lethargic C28104 Patient Characteristics Qualifier FDA C54450 Patient_Problem_Codes_FDA_CDRH C50414 2580 Hospitalization Required Required hospitalization C16669 Health Status FDA C54450 Patient_Problem_Codes_FDA_CDRH C50415 2155 Improved Patient Condition Condition of patient, improved|Patient condition, improved C27992 Disease Qualifier FDA C54450 Patient_Problem_Codes_FDA_CDRH C50416 1718 Apgar Score, Decreased Or Low Low or decreased apgar score|Score, decreased or low apgar|Decreased or low apgar score C73437 Apgar Score FDA C54450 Patient_Problem_Codes_FDA_CDRH C50417 1028 Anastomose, Failure To C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50418 1802 Death/Expired Expired/death C25717 Vital Status FDA C54450 Patient_Problem_Codes_FDA_CDRH C50419 2035 Reaction, Local Local reaction C25637 2414 Reaction FDA C54450 Patient_Problem_Codes_FDA_CDRH C50421 2563 Surgical Procedure Aborted/Stopped Procedure aborted/stopped, surgical C45501 Treatment Status FDA C54450 Patient_Problem_Codes_FDA_CDRH C50422 2565 Surgical Procedure, Delayed Procedure, delayed surgical C45501 Treatment Status FDA C54450 Patient_Problem_Codes_FDA_CDRH C50423 2518 Therapy/Non-Surgical Treatment, Aborted/Stopped Treatment (non-surgical)/therapy, aborted/stopped|Non-surgical treatment/therapy, aborted/stopped C45501 Treatment Status FDA C54450 Patient_Problem_Codes_FDA_CDRH C50424 2519 Therapy/Non-Surgical Treatment, Additional Non-surgical treatment/therapy, additional C45501 Treatment Status FDA C54450 Patient_Problem_Codes_FDA_CDRH C50425 2520 Therapy/Non-Surgical Treatment/Delayed/Prolonged Therapy/non-surgical treatment, delayed|Treatment (non-surgical)/therapy, delayed|Non-surgical treatment/therapy, delayed C45501 Treatment Status FDA C54450 Patient_Problem_Codes_FDA_CDRH C50429 2561 Missed Dose Dose, missed C20181 Conceptual Entity FDA C54450 Patient_Problem_Codes_FDA_CDRH C50430 2395 Ventilator Dependent Dependent, ventilator C16960 Patient FDA C54450 Patient_Problem_Codes_FDA_CDRH C50431 2370 Mammogram, Abnormal Abnormal mammogram C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50432 2159 Misdiagnosis C43369 Error FDA C54450 Patient_Problem_Codes_FDA_CDRH C50435 2613 Wrinkling C20181 Conceptual Entity FDA C54450 Patient_Problem_Codes_FDA_CDRH C50436 2261 Seizures, Absence Petit-mal seizures|Seizures, Petit-Mal 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. Generalized seizure that manifests in a form of a brief episode of impairment of consciousness with or without accompanying motor phenomena such as clonic-tonic components, automatisms, or autonomic components. C2962 2063 Seizures FDA C54450 Patient_Problem_Codes_FDA_CDRH C50437 2225 Discharge C4876 Symptom FDA C54450 Patient_Problem_Codes_FDA_CDRH C50438 1891 Intracranial hemorrhage Bleeding, Intracranial|Intracranial bleeding|Hemorrhage, Intracranial Bleeding within the cranium. Bleeding within the cranium. C26791 1888 Hemorrhage FDA C54450 Patient_Problem_Codes_FDA_CDRH C50440 2219 Brain Injury Brain Damage|Injury, brain C4974 Nervous System Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C50441 1787 Contusion A bruise; an injury of a part without a break in the skin. A bruise; an injury of a part without a break in the skin. C3671 2348 Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C50443 1750 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. 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. C3824 Lesion FDA C54450 Patient_Problem_Codes_FDA_CDRH C50444 1868 Foreign Body Reaction Reaction, foreign body 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. 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. C36291 Finding by Cause FDA C54450 Patient_Problem_Codes_FDA_CDRH C50445 2352 Hypoesthesia Consisting of abnormally decreased sensitivity, particularly to touch. Impairment of tactile sensitivity manifesting as partial loss of sensitivity to sensory stimuli. C5040 Sensory Manifestations FDA C54450 Patient_Problem_Codes_FDA_CDRH C50446 1946 Laceration(s) C3671 2348 Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C50447 1034 Blood Gas Measurements, Abnormal Abnormal blood gas measurements|Measurements, abnormal blood gas C35553 Abnormal Blood Chemistry and Hematology Test Result FDA C54450 Patient_Problem_Codes_FDA_CDRH C50448 2078 Ventricle, Abnormality Of C9440 Abnormality FDA C54450 Patient_Problem_Codes_FDA_CDRH C50449 1689 Abrasion Abraded wound; excoriation or circumscribed removal of the superficial layers of the skin or mucous membrane. C3671 2348 Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C50450 1945 Keratitis, Acanthamoeba Acanthamoeba keratitis Keratitis due to infection by acanthamoeba; it is usually associated with soft contact lens wear, particularly overnight wear. Keratitis due to infection by acanthamoeba; it is usually associated with soft contact lens wear, particularly overnight wear. C26805 1944 Keratitis FDA C54450 Patient_Problem_Codes_FDA_CDRH C50451 1692 Achalasia Failure of the smooth muscle fibers of the gastrointestinal tract to relax at any one point of junction of one part with another. Failure of the smooth muscle fibers of the gastrointestinal tract to relax at any one point of junction of one part with another. C3368 Gastrointestinal System Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C50452 1693 Shock, Acoustic Acoustic Shock C3671 2348 Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C50453 1694 Acoustic Trauma Injury to the hearing mechanisms within the inner ear, caused by excessively loud noise. C27160 Injury of Inner Ear FDA C54450 Patient_Problem_Codes_FDA_CDRH C50454 2269 Toxoplasmosis, Acquired Acquired toxoplasmosis Acquired as an adult. C3418 Toxoplasmosis FDA C54450 Patient_Problem_Codes_FDA_CDRH C50455 1697 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. 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. C26759 1829 Embolism FDA C54450 Patient_Problem_Codes_FDA_CDRH C50456 1699 Airway Obstruction C45233 Respiratory System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50457 2551 Cognitive Changes Changes, cognitive 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. C36280 Nervous System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50458 2544 Ambulation Difficulties Difficulties, ambulation C4876 Symptom FDA C54450 Patient_Problem_Codes_FDA_CDRH C50459 2217 Amnionitis Inflammation of the amnion. Inflammation of the amnion. C27583 Infectious Disorder by Site FDA C54450 Patient_Problem_Codes_FDA_CDRH C50460 1703 Shock, Anaphylactic Anaphylaxis|Anaphylactic shock 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. An acute inflammatory reaction resulting from combination of a soluble antigen with IgE bound to a mast cell that leads to degranulation of the mast cell and release of histamine and histamine like substances, causing localized or global hypersensitivity immune reponses. C35016 2072 Shock FDA C54450 Patient_Problem_Codes_FDA_CDRH C50461 2491 Aortic Dissection Dissection, Aortic C35317 Arterial Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50462 1717 Aortic Stenosis Narrowing of the orifice of the aortic valve or of the supravalvular or subvalvular regions. Narrowing of the orifice of the aortic valve or of the supravalvular or subvalvular regions. C62433 Valvular Stenosis FDA C54450 Patient_Problem_Codes_FDA_CDRH C50463 2353 Hypoesthesia, Arm/Hand Consisting of abnormally decreased sensitivity, particularly to touch. C50445 2352 Hypoesthesia FDA C54450 Patient_Problem_Codes_FDA_CDRH C50464 2355 Arthralgia Pain, joint|Joint pain Pain in a joint. Pain in a joint. C3303 1994 Pain FDA C54450 Patient_Problem_Codes_FDA_CDRH C50465 1851 Asphyxia A condition due to lack of oxygen in respired air, resulting in impending or actual cessation of life. C3890 1918 Hypoxia FDA C54450 Patient_Problem_Codes_FDA_CDRH C50466 1729 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. A supraventricular arrhythmia characterized by uncoordinated atrial myocardium activation due to multiple reentry circuits with consequent deterioration of atrial mechanical function. Instead of intermittently contracting, the atria quiver continuously in a chaotic pattern, causing a totally irregular, often tachycardia ventricular rate. On the ECG it is described by the replacement of consistent P waves by rapid oscillations or fibrillatory waves that vary in size, shape, and timing, associated with an irregular, frequently rapid ventricular response when atrioventricular conduction is intact. C27158 Supraventricular Arrhythmia FDA C54450 Patient_Problem_Codes_FDA_CDRH C50467 2511 Atrial Perforation C45430 Heart Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C50469 2143 Vitreous Fluid, Blood In Fluid, blood in vitreous|Blood in vitreous fluid C36283 Eye and Ear Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50470 2597 Blood loss Loss of blood C5044 Fluid and Electrolyte Manifestation FDA C54450 Patient_Problem_Codes_FDA_CDRH C50472 1803 Debris, Bone Shedding Bone shedding debris|Shedding of bone debris Shedding of accumulated bone fragments. Shedding of accumulated bone fragments. C36288 Connective and Soft Tissue Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50473 1756 Burn, Bowel Bowel burn C34441 1757 Burn(s) FDA C54450 Patient_Problem_Codes_FDA_CDRH C50474 2485 Respiratory Rate, Decreased Decreased respiratory rate|Rate of respiration, decreased Abnormal decrease of rate of breathing. C3676 Alteration in Respiration FDA C54450 Patient_Problem_Codes_FDA_CDRH C50475 2106 Optical tissue, breakdown of Tissue, Breakdown Of Optical C34602 1845 Eye injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C50476 2146 Burning Sensation Sensation, burning C5040 Sensory Manifestations FDA C54450 Patient_Problem_Codes_FDA_CDRH C50477 1760 Cancer, Other C9305 Malignant Neoplasm FDA C54450 Patient_Problem_Codes_FDA_CDRH C50479 1762 Cardiac Arrest Arrest, cardiac|Asystole Sudden cessation of the pumping function of the heart, with disappearance of arterial blood pressure, connoting either ventricular fibrillation or ventricular standstill. Sudden cessation of the pumping function of the heart, with disappearance of arterial blood pressure, connoting either ventricular fibrillation or ventricular standstill. C35741 Non-Neoplastic Heart Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50480 1838 Enzyme Elevation, Cardiac Cardiac enzyme elevation|Elevation of cardiac enzymes C35553 Abnormal Blood Chemistry and Hematology Test Result FDA C54450 Patient_Problem_Codes_FDA_CDRH C50481 2226 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. 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. C3079 Heart Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50482 2262 Shock, Cardiogenic Cardiogenic shock 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. 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. C35016 2072 Shock FDA C54450 Patient_Problem_Codes_FDA_CDRH C50483 1765 Cardiopulmonary Arrest Arrest, cardiopulmonary Cessation of breathing and/or cardiac function. Cessation of breathing and/or cardiac function. C36278 Finding by Site or System FDA C54450 Patient_Problem_Codes_FDA_CDRH C50484 2599 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. 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. C35577 Traumatic Hemorrhage FDA C54450 Patient_Problem_Codes_FDA_CDRH C50485 1889 Hemorrhage, cerebral Bleeding, cerebral|Cerebral hemorrhage|Cerebral bleeding Hemorrhage into the cerebrum. See also Stroke Syndrome. Bleeding within the cerebrum. C50438 1891 Intracranial hemorrhage FDA C54450 Patient_Problem_Codes_FDA_CDRH C50486 1771 Infarction, cerebral Cerebral, Infarction An ischemic condition of the brain, producing a persistent focal neurological deficit in the area of distribution of the cerebral arteries. An ischemic condition of the brain, producing a persistent focal neurological deficit in the area of distribution of the cerebral arteries. C2938 Cerebrovascular Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50487 1772 Cerebrospinal Fluid Leakage Leakage of cerebrospinal fluid|Fluid, leakage of cerebrospinal C40419 Body Fluid Leakage FDA C54450 Patient_Problem_Codes_FDA_CDRH C50488 1773 Cervical Changes Cervical Change|Changes, cervical Changes such as abnormal, pathological, benign, malignant, etc. C36284 Reproductive System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50489 1831 Emotional Changes Changes, emotional C36280 Nervous System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50490 1775 Chemosis Excessive edema of the ocular conjunctiva. Edema of the mucous membrane of the eyeball and eyelid lining. C3002 1820 Edema FDA C54450 Patient_Problem_Codes_FDA_CDRH C50491 2463 Chest Tightness/Pressure Tightness/pressure in chest|Pressure/tightness in chest C4876 Symptom FDA C54450 Patient_Problem_Codes_FDA_CDRH C50492 2670 Difficulty Chewing C4876 Symptom FDA C54450 Patient_Problem_Codes_FDA_CDRH C50493 2098 Toxins In Children Children, toxins in Children affected by toxins may be due to silicone breast implants and their effects on unborn children and from breastfeeding. C52681 Adverse Event by Cause FDA C54450 Patient_Problem_Codes_FDA_CDRH C50494 2464 Choking A condition caused by blocking the airways to the lungs and interference with the respiration by compression or obstruction of the larynx or trachea. C3671 2348 Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C50495 2550 Claudication Limping or lameness. C4876 Symptom FDA C54450 Patient_Problem_Codes_FDA_CDRH C50496 2222 Convulsion, Clonic Clonic convulsion A convulsion marked by alternating contracting and relaxing of the muscles. A convulsion marked by alternating contracting and relaxing of the muscles. C3837 Neurological Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C50497 2416 Collapse C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50499 2331 Complaint, Ill-Defined Ill-defined complaint C20181 Conceptual Entity FDA C54450 Patient_Problem_Codes_FDA_CDRH C50500 2212 Abortion, Complete All products of conception are expelled and identified. C35221 1688 Abortion FDA C54450 Patient_Problem_Codes_FDA_CDRH C50501 2627 Complete Heart Block Complete failure of atrial electrical impulse conduction through the AV node to the ventricles. C26703 Atrioventricular Block FDA C54450 Patient_Problem_Codes_FDA_CDRH C50502 2192 Concussion A violent jar or shock, or the condition which results from such an injury. A violent jar or shock, or the condition which results from such an injury. C3671 2348 Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C50503 2270 Toxoplasmosis, Congenital Congenital toxoplasmosis Passed from mother to fetus. C3418 Toxoplasmosis FDA C54450 Patient_Problem_Codes_FDA_CDRH C50504 2234 Overwear Syndrome Syndrome, overwear 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. 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. C27604 Non-Neoplastic Eye Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50505 1745 Cross-patient exposure to body fluids Blood/fluids, contamination from|Fluids/blood, contamination from|Contamination From Blood/Fluids The patient becomes contaminated from contact with blood/fluids on a device. The patient becomes contaminated from contact with blood/fluids on a device. C36291 Finding by Cause FDA C54450 Patient_Problem_Codes_FDA_CDRH C50506 2523 Burn, Corneal Corneal burn C34441 1757 Burn(s) FDA C54450 Patient_Problem_Codes_FDA_CDRH C50507 1790 Corneal Decompensation Decompensation, corneal Inability to maintain corneal integrity; or corneal edema resulting from failure of the corneal endothelium to maintain detumescence. Endothelial decompensation that is manifested by opacity of the cornea. The condition often occurs as a nonspecific response to mechanical injury from incidental corneal contact by intraocular instruments during surgery; chemical injury from the improper use of intraocular drugs, drugs containing preservatives, or from residues from inadequate rinsing of detergents or other residues from surgical instruments. The most common causes of corneal endothelial decompensation in the adult population are cataract removal/IOL-related endothelial loss and Fuchs dystrophy. When severe, corneal endothelial decompensation requires corneal transplantation. C27608 Non-Neoplastic Corneal Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50508 1791 Corneal Edema Edema, corneal Hazy, swollen cornea. Hazy, swollen cornea. C3002 1820 Edema FDA C54450 Patient_Problem_Codes_FDA_CDRH C50509 1878 Corneal haze Haze C36283 Eye and Ear Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50510 2231 Corneal Infiltrates Infiltrates, corneal 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. 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. C36283 Eye and Ear Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50511 1793 Corneal Scar Scar, corneal C34483 2061 Scarring FDA C54450 Patient_Problem_Codes_FDA_CDRH C50513 1794 Corneal Touch Touch, corneal Complications of intraocular lens surgery; usually refers to intraocular lens contact with cornea, can be intermittent or chronic. Complications of intraocular lens surgery; usually refers to intraocular lens contact with cornea, can be intermittent or chronic. C36283 Eye and Ear Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50514 1795 Corneal Transplant Transplant, corneal C50920 2110 Transplant Of Organ/Tissue FDA C54450 Patient_Problem_Codes_FDA_CDRH C50515 1796 Corneal Ulcer Ulcer, corneal Area of epithelial tissue loss from corneal surface; associated with inflammatory cells in the cornea and anterior chamber. Area of epithelial tissue loss from corneal surface; associated with inflammatory cells in the cornea and anterior chamber. C27608 Non-Neoplastic Corneal Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50517 2656 Cusp Tear C45525 Valvular Heart Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50519 1799 Cyclitis Inflammation of the ciliary body. Inflammation of the ciliary body. C27604 Non-Neoplastic Eye Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50520 1800 Cyst(s), Formation Of Formation of cyst(s) C41454 Cystic Change FDA C54450 Patient_Problem_Codes_FDA_CDRH C50521 1957 Cytomegaloviral Retinitis Retinitis, cytomegaloviral C53649 Cytomegaloviral Infection FDA C54450 Patient_Problem_Codes_FDA_CDRH C50522 2124 Vaginal Mucosa Damage Mucosa damage, vaginal|Damage, vaginal mucosa C3671 2348 Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C50523 1915 Hypothermia Body temperature, decreased|Decreased body temperature|Temperature, decreased body Abnormally low body temperature. Abnormally low body temperature. C7941 Alteration in Body Temperature FDA C54450 Patient_Problem_Codes_FDA_CDRH C50524 2430 Forced Expiratory Volume, Decreased FEV decreased|FEV (forced expiratory volume), decreased|Decreased forced expiratory volume (FEV)|Volume (FEV), decreased forced expiratory|Forced expiratory volume (FEV), decreased A decrease in the fraction of the forced vital capacity that is exhaled in a specific number of seconds. A decrease in the fraction of the forced vital capacity that is exhaled in a specific number of seconds. C45233 Respiratory System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50525 2435 Peak Expiratory Flowrate, Decreased Decreased peak expiratory flowrate|Flowrate, decreased peak expiratory A decrease of the greatest rate of flow that can be achieved during forced expiration beginning with the lungs fully inflated. Decreased expiratory peak flow measurement achieved during forced expiration that primarily reflects changes in upper airway conductance and may be of limited use in evaluation of changes in peripheral airway conductance. Evaluation of peak flow performance is subjective, and, therefore, acceptability criteria are lacking. Because the maneuver is effort and volume dependent, the patient must be encouraged to perform as vigorously as clinically feasible. The results of subjective evaluation may be difficult to interpret consistently. A validated dyspnea rating scale may be useful. C45233 Respiratory System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50526 2271 Therapeutic Response, Decreased Decreased therapeutic response|Response, decreased therapeutic C35461 Clinical Course of Disease FDA C54450 Patient_Problem_Codes_FDA_CDRH C50527 2502 Dehiscence of organ Dehiscence A splitting open of an anatomical structure, zone, or organ with the exposure or discharge of its content. C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50529 2369 Fracture, Delayed Union Delayed union fracture|Union fracture, delayed A bone fracture that is taking an abnormally long time to heal. C3046 1870 Fracture(s) FDA C54450 Patient_Problem_Codes_FDA_CDRH C50530 2364 Diabetic Ketoacidosis Ketoacidosis, diabetic A type of metabolic acidosis produced by accumulation of ketone bodies resulting from uncontrolled diabetes mellitus. The metabolic condition resulted from uncontrolled diabetes mellitus, in which the shift of acid-base status of the body toward the acid side because of loss of base or retention of acids other than carbonic acid is accompanied by the accumulation of ketone bodies in body tissues and fluids. C28228 Acidosis FDA C54450 Patient_Problem_Codes_FDA_CDRH C50531 2224 Dementia, Dialysis Dialysis dementia A severe, often fatal encephalopathy which has been attributed to accumulation in the brain of aluminum from dialysate prepared with inadequately purified water. A severe, often fatal encephalopathy which has been attributed to accumulation in the brain of aluminum from dialysate prepared with inadequately purified water. C26920 1833 Encephalopathy FDA C54450 Patient_Problem_Codes_FDA_CDRH C50532 2239 First Use Syndrome Syndrome, first use 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. 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. C28193 Syndrome FDA C54450 Patient_Problem_Codes_FDA_CDRH C50533 2606 Pulse pressure, diminished Pulse, Diminished|Pulse, diminished C35552 Cardiovascular System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50534 2244 Infection, Direct Direct infection Infection produced by direct contact with another person. Infection produced by direct contact with another person. C26726 1930 Infection FDA C54450 Patient_Problem_Codes_FDA_CDRH C50535 2330 Discomfort A feeling of mental or physical uneasiness, pain, or distress. C4876 Symptom FDA C54450 Patient_Problem_Codes_FDA_CDRH C50536 2360 Disfigurement C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50537 2601 Distention C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50539 2363 Dyskinesia Difficulty moving; distortion or impairment of voluntary movement, as in tic, spasm, or myoclonus. Difficulty moving; distortion or impairment of voluntary movement, as in tic, spasm, or myoclonus. C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50540 2059 ST Segment Elevation Elevation, ST segment Evaluation of the interval from the end of ventricular depolarization to the onset of the T wave; it is usually isoelectric in normal subjects. EKG ST segment elevation is usually attributed to impending infarction, but can also be due to pericarditis or vasospastic (variant) angina and early repolarization. In some healthy young adults, a form of ST elevation can be normal. The height of the ST segment is measured at a point 2 boxes after the end of the QRS complex. ST segment elevation is considered significant if it exceeds 1 mm in a limb lead or 2 mm in a precordial lead. C41328 Electrocardiographic Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50541 2554 Electric Shock Electrical Shock|Shock, Electrical|Shock, electric C45407 Electrical Exposure FDA C54450 Patient_Problem_Codes_FDA_CDRH C50542 1826 Electro-Mechanical Dissociation Dissociation, electro-mechanical Continued electrical rhythmicity of the heart in the absence of effective mechanical function. A phenomenon characterized by the presence of cardiac electrical rhythm without a proper response of the myocardial tissue and mechanical cardiac output. EMD may imply that there is little viable or functional myocardium. The condition may also be associated with profound hypovolaemia, drug toxicity, electrolyte imbalance or mechanical obstruction to cardiac output such as pulmonary embolism, cardiac tamponade or tension pneumothorax. C35552 Cardiovascular System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50543 1817 EKG/ECG Changes ECG/EKG changes|Changes in EKG/ECG Changes in cardiac electrical activity. Changes in cardiac electrical activity. C41328 Electrocardiographic Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50544 1827 Electrocution The passage of electrical current through the body. The passage of electrical current through the body. C45407 Electrical Exposure FDA C54450 Patient_Problem_Codes_FDA_CDRH C50545 2196 Electrolyte Imbalance Imbalance, electrolyte Higher or lower than normal values for the serum electrolytes; usually affecting NA, K, CHL, CO2, glucose, bun. Higher or lower than normal values for the serum electrolytes; usually affecting NA, K, CHL, CO2, glucose, bun. C5044 Fluid and Electrolyte Manifestation FDA C54450 Patient_Problem_Codes_FDA_CDRH C50547 1830 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. 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. C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50548 2327 Entrapment Patient becomes entangled or caught in a bed, particularly in side rails, or mattress, or head/foot boards. C3671 2348 Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C50549 2232 Microcysts, Epithelial Epithelial microcysts 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. 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. C36283 Eye and Ear Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50550 1839 Eructate To belch, the casting of upwind from the stomach. To belch, the casting of upwind from the stomach. C36279 Gastrointestinal System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50551 2229 Blinking, Excessive Excessive blinking C36283 Eye and Ear Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50552 2235 Tearing, Excessive Excessive tearing C4876 Symptom FDA C54450 Patient_Problem_Codes_FDA_CDRH C50553 2628 Exit Block A blockage of electrical conduction within the sinoatrial node resulting in the prolongation or failure (intermittent or complete) of impulse transmission from the sinoatrial node to the surrounding atrial tissue. C34665 Heart Block FDA C54450 Patient_Problem_Codes_FDA_CDRH C50555 1890 Hemorrhage, Extradural Extradural hemorrhage Intracranial hemorrhage into the epidural space. Intracranial hemorrhage into the epidural space. C26791 1888 Hemorrhage FDA C54450 Patient_Problem_Codes_FDA_CDRH C50556 1843 Extreme Exhaustion Exhaustion, extreme Extreme fatigue; inability to respond to stimuli. Extreme fatigue; inability to respond to stimuli. C3036 1849 Fatigue FDA C54450 Patient_Problem_Codes_FDA_CDRH C50558 1848 Fall C4876 Symptom FDA C54450 Patient_Problem_Codes_FDA_CDRH C50559 2375 Fasciitis Inflammation of fascia. Inflammation process in fascia. C27573 Non-Neoplastic Soft Tissue Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50560 1850 Feeding Problems Problems, feeding C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50563 1856 Fetal Distress Distress, fetal C34941 Pregnancy Complication FDA C54450 Patient_Problem_Codes_FDA_CDRH C50564 2210 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. 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. C3890 1918 Hypoxia FDA C54450 Patient_Problem_Codes_FDA_CDRH C50566 1860 Fibromyositis Inflammation and fibrous degeneration of a muscle. Inflammation and fibrous degeneration of a muscle. C27573 Non-Neoplastic Soft Tissue Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50567 1972 Necrosis Of Flap Tissue Tissue, necrosis of flap|Flap tissue, necrosis of C36184 Necrotic Change FDA C54450 Patient_Problem_Codes_FDA_CDRH C50568 1864 Flashers A sudden or brief burst of light. A sudden or brief burst of light. C5042 Visual Manifestations FDA C54450 Patient_Problem_Codes_FDA_CDRH C50569 1865 Flatus Gas or air in the gastrointestinal tract. Gas or air in the gastrointestinal tract. C36279 Gastrointestinal System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50570 2667 Follow-Up Bowel Resection Required C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50571 2354 Hypoesthesia, Foot/Leg Leg/foot hypoesthesia|Foot/leg hypoesthesia Consisting of abnormally decreased sensitivity, particularly to touch. C50445 2352 Hypoesthesia FDA C54450 Patient_Problem_Codes_FDA_CDRH C50572 1869 Foreign Body Sensation Sensation, foreign body 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. 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. C36291 Finding by Cause FDA C54450 Patient_Problem_Codes_FDA_CDRH C50573 1873 Gangrene Death of tissue, usually in considerable mass and generally associated with loss of vascular (nutritive) supply and followed by bacterial invasion and putrefaction. Death of tissue, usually in considerable mass and generally associated with loss of vascular (nutritive) supply and followed by bacterial invasion and putrefaction. C36184 Necrotic Change FDA C54450 Patient_Problem_Codes_FDA_CDRH C50574 2168 Seizures, Grand-Mal Grand-mal seizures A symptomatic form of epilepsy often preceded by an aura; characterized by loss of consciousness with generalized tonic- clonic seizures. A generalized tonic-clinic seizure, characterized by loss of consciousness. This type of seizure may be preceded by an aura and is frequently followed by a period of confusion and lethargy (post-ictal state). C2962 2063 Seizures FDA C54450 Patient_Problem_Codes_FDA_CDRH C50575 1877 Hair Loss Loss of hair C36281 Integumentary System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50576 1881 Hearing Impairment Impairment, hearing C3078 Hearing Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50577 2206 Heart Failure Cardiac Insufficiency|Insufficiency, cardiac|Failure, Heart 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. Inability of the heart to pump blood at an adequate rate to meet tissue metabolic requirements or the ability to do so only at an elevated filling pressure. C35741 Non-Neoplastic Heart Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50578 2666 Heavier Menses C3232 Menstruation FDA C54450 Patient_Problem_Codes_FDA_CDRH C50579 1884 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. A localized collection of blood, usually clotted, in an organ, space, or tissue, due to a break in the wall of a blood vessel. C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50580 1288 Hemoconcentration An increase in the concentration of blood cells resulting from the loss of plasma or water from the blood stream. An increase in the concentration of blood cells resulting from the loss of plasma or water from the blood stream. C5044 Fluid and Electrolyte Manifestation FDA C54450 Patient_Problem_Codes_FDA_CDRH C50581 1895 Hemostasis The arrest of bleeding, either by the physiological properties of vasoconstriction and coagulation or by surgical means. The arrest of bleeding, either by the physiological properties of vasoconstriction and coagulation or by surgical means. C20181 Conceptual Entity FDA C54450 Patient_Problem_Codes_FDA_CDRH C50582 1896 Hemothorax A collection of blood in the pleural cavity. A collection of blood in the pleural cavity. C35742 Thoracic Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50583 1898 Herpes Any inflammatory skin disease caused by a herpesvirus and characterized by the formation of small vesicles in clusters. Any inflammatory skin disease caused by a herpesvirus and characterized by the formation of small vesicles in clusters. C3439 2248 Infection, Viral FDA C54450 Patient_Problem_Codes_FDA_CDRH C50584 2478 Oxygen Saturation, High High oxygen saturation|Saturation, high oxygen The calculated measurements indicating the degree to which oxygen is bound to hemoglobin is high. A high level of the degree to which oxygen is bound to hemoglobin given as a percentage calculated by dividing the maximum oxygen capacity into the actual oxygen content and multiplying by 100. Oxygen saturation usually is measured using pulse oximetry. C5044 Fluid and Electrolyte Manifestation FDA C54450 Patient_Problem_Codes_FDA_CDRH C50585 2480 Pulmonary Arterial Wedge Pressure, High Arterial wedge pressure, high pulmonary|Wedge pressure, high pulmonary arterial|Pressure, high pulmonary arterial wedge|High pulmonary arterial wedge pressure The measurement of the mean left arterial pressure, as measured by a catheter introduced into the distal pulmonary artery, is high. The measurement of the mean left arterial pressure, as measured by a catheter introduced into the distal pulmonary artery, is high. C35552 Cardiovascular System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50586 1297 Host-Tissue Reaction Tissue, reaction of host|Reaction of host-tissue Growth of tissue in or around a foreign body as the body's antibody response to the foreign body. Growth of tissue in or around a foreign body as the body's antibody response to the foreign body. C50444 1868 Foreign Body Reaction FDA C54450 Patient_Problem_Codes_FDA_CDRH C50587 2181 Vitritis Inflammatory intraocular reaction with clouding and cells in vitreous; often accompanies inflammation of ciliary body, iris, choroid, or retina. Inflammatory intraocular reaction with clouding and cells in vitreous; often accompanies inflammation of ciliary body, iris, choroid, or retina. C45256 Vitreous Body Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50588 1904 Hyperemia The presence of an increased amount of blood in a part or organ; engorgement. The presence of an increased amount of blood in a part or organ; engorgement. C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50589 1909 Hyperthermia A condition that manifests with abnormally high body temperature. In hyperthermic state, the hypothalamic set-point is normal but body temperature increases and overrides the ability to lose heat, resulting from exogenous heat exposure or endogenous heat production, e.g. in heat stroke, malignant hyperthermia, endocrine hyperthermia, or neuroleptic malignant syndrome. The concept does not refer to hyperpyrexia, the state when the hypothalamic set-point is reset at a higher temperature and is physiologically regulated. C7941 Alteration in Body Temperature FDA C54450 Patient_Problem_Codes_FDA_CDRH C50590 1910 Hyperventilation Abnormally prolonged, rapid, and deep breathing. Abnormally prolonged, rapid, and deep breathing. C45233 Respiratory System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50591 2664 Hypervolemia C5044 Fluid and Electrolyte Manifestation FDA C54450 Patient_Problem_Codes_FDA_CDRH C50592 1911 Hyphema Hemorrhage within the anterior chamber of the eye; bloodshot. Hemorrhage within the anterior chamber of the eye; bloodshot. C27604 Non-Neoplastic Eye Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50593 1913 Hypopyon An accumulation of pus in the anterior chamber of the eye. An accumulation of pus in the anterior chamber of the eye. C45372 Eye Infection FDA C54450 Patient_Problem_Codes_FDA_CDRH C50594 1916 Hypoventilation A state in which there is a reduced amount of air entering the pulmonary alveoli. A state in which there is a reduced amount of air entering the pulmonary alveoli. C45233 Respiratory System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50595 2243 Hypovolemia Abnormally decreased volume of circulating fluid (plasma) in body. Abnormally decreased volume of circulating fluid (plasma) in body. C5044 Fluid and Electrolyte Manifestation FDA C54450 Patient_Problem_Codes_FDA_CDRH C50596 1917 Shock, Hypovolemic Hypovolemic shock Shock resulting from insufficient blood volume for the maintenance of adequate cardiac output, blood pressure and tissue perfusion. Shock resulting from insufficient blood volume for the maintenance of adequate cardiac output, blood pressure and tissue perfusion. C35016 2072 Shock FDA C54450 Patient_Problem_Codes_FDA_CDRH C50598 2498 Iatrogenic Source Source, iatogenic C36291 Finding by Cause FDA C54450 Patient_Problem_Codes_FDA_CDRH C50599 1923 Idioventricular Rhythm Rhythm, idioventricular Relating to or affecting the cardiac ventricles alone. C35552 Cardiovascular System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50600 2572 Vascular system (circulation), impaired Circulation, impaired|Impaired circulation C35552 Cardiovascular System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50601 2378 Healing, Impaired Impaired healing C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50602 2138 Vision, Impaired Impaired vision C5042 Visual Manifestations FDA C54450 Patient_Problem_Codes_FDA_CDRH C50603 1924 Implant, Failure Of Failure of implant 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. C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50605 2388 Pain Relief, Inadequate Inadequate pain relief C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50607 1927 Incompetent Cervix Cervix, incompetent One that is abnormally prone to dilate in the second trimester of pregnancy, resulting in premature expulsion of the fetus. One that is abnormally prone to dilate in the second trimester of pregnancy, resulting in premature expulsion of the fetus. C34941 Pregnancy Complication FDA C54450 Patient_Problem_Codes_FDA_CDRH C50608 2213 Abortion, Incomplete The uterus is not entirely emptied of its contents. C35221 1688 Abortion FDA C54450 Patient_Problem_Codes_FDA_CDRH C50609 2431 Forced Expiratory Volume, Increased FEV increased|Forced expiratory volume (FEV), increased|FEV, (forced expiratory volume), increased|Increased forced expiratory volume (FEV)|Volume (FEV), increased forced expiratory An increase in the fraction of the forced vital capacity that is exhaled in a specific number of seconds. An increase in the fraction of the forced vital capacity that is exhaled in a specific number of seconds. C45233 Respiratory System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50610 2436 Peak Expiratory Flowrate, Increased Flowrate, increased peak expiratory|Increased peak expiratory flowrate An increase of the greatest rate of flow that can be achieved during forced expiration beginning with the lungs fully inflated. An increase of the greatest rate of flow that can be achieved during forced expiration beginning with the lungs fully inflated. C45233 Respiratory System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50611 2272 Therapeutic Response, Increased Response, increased therapeutic|Increased therapeutic response C35461 Clinical Course of Disease FDA C54450 Patient_Problem_Codes_FDA_CDRH C50612 2245 Infection, Indirect Indirect infection Infection transmitted by water, food or other means of conveyance. C26726 1930 Infection FDA C54450 Patient_Problem_Codes_FDA_CDRH C50613 2214 Abortion, Induced Abortion, Artificial|Induced abortion|Artificial abortion Abortion brought on intentionally. Abortion brought on intentionally. C35221 1688 Abortion FDA C54450 Patient_Problem_Codes_FDA_CDRH C50614 1767 Cataract, Induced Induced cataract 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. 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. C26713 1766 Cataract FDA C54450 Patient_Problem_Codes_FDA_CDRH C50615 2264 Shock, Insulin Insulin shock A hypoglycemic reaction to overdosage of insulin, a skipped meal, or strenuous exercise in an insulin-dependent diabetic. A hypoglycemic reaction to overdosage of insulin, a skipped meal, or strenuous exercise in an insulin-dependent diabetic. C35016 2072 Shock FDA C54450 Patient_Problem_Codes_FDA_CDRH C50616 1333 Intimal Dissection Dissection, intimal Pertaining to the inner layer of the blood vessels. C35317 Arterial Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50617 1933 Infection, Intraocular Intraocular infection Infection within the eye. Infection within the eye. C45372 Eye Infection FDA C54450 Patient_Problem_Codes_FDA_CDRH C50618 1937 Intraocular Pressure Rise IOPR|IOPR, intraocular pressure rise|Intraocular pressure rise, (IOPR)|Rise in intraocular pressure, (IOPR)|Pressure (IOPR), rise in intraocular Increase of pressure of the intraocular fluid in the eye. Increase of pressure of the intraocular fluid in the eye. C36283 Eye and Ear Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50619 2662 Intraoperative Pain C3303 1994 Pain FDA C54450 Patient_Problem_Codes_FDA_CDRH C50620 1855 Death, Intrauterine Fetal Intrauterine fetal death|Fetal death, intrauterinel 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. 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. C34941 Pregnancy Complication FDA C54450 Patient_Problem_Codes_FDA_CDRH C50621 1940 Iritis Inflammation of the iris. Inflammation of the iris. C27604 Non-Neoplastic Eye Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50622 2469 Pulse, Irregular Irregular pulse A pulse that beats at irregular intervals. Not rhythmic pulse irregular in beat or accent. C35552 Cardiovascular System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50623 2421 Irritability An abnormal responsiveness or morbid excitability of an organ, its part, or entire organism or its part to stimuli. C36280 Nervous System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50624 1941 Irritation A mild inflammatory tissue reaction; it can be caused by physical contact with an irritant or can be a local response to a systemic trigger. C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50625 2493 Ischemic Heart Disease Disease, ischemic heart|Heart disease, ischemic A disorder of cardiac function caused by insufficient blood flow to the muscle tissue of the heart. The decreased blood flow may be due to narrowing of the coronary arteries, to obstruction by a thrombus, or less commonly, to diffuse narrowing of arterioles and other small vessels within the heart. Severe interruption of the blood supply to the myocardial tissue may result in necrosis of cardiac muscle (myocardial infarction). C35741 Non-Neoplastic Heart Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50627 2356 Joint Swelling Swelling, joint C36288 Connective and Soft Tissue Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50629 1947 Left Ventricular Dysfunction Dysfunction, left ventricular|Ventricular dysfunction, left C35552 Cardiovascular System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50630 1948 Left Ventricular Failure Failure, left ventricular|Ventricular failure, left 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 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. C50577 2206 Heart Failure FDA C54450 Patient_Problem_Codes_FDA_CDRH C50631 1949 Left Ventricular Hypertrophy Ventricular hypertrophy, left Enlargement or overgrowth of the myocardium of the left ventricle, due to chronic pressure overload. Enlargement or overgrowth of the myocardium of the left ventricle, due to chronic pressure overload. C35552 Cardiovascular System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50633 1952 Ligament(s), Damage To Damage to ligament(s) C3671 2348 Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C50634 1954 Liver Dysfunction Dysfunction, liver C36279 Gastrointestinal System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50635 Loss of consciousness The neurologic status characterized by the occurrence of a loss of the ability to perceive and respond. C36280 Nervous System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50636 2562 Loss of pulse Pulse, Loss Of C35552 Cardiovascular System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50637 2032 Range Of Motion, Loss Of Loss of range of motion|Motion, loss of range of C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50638 2139 Vision, Loss Of Loss of vision C5042 Visual Manifestations FDA C54450 Patient_Problem_Codes_FDA_CDRH C50639 2142 Vitreous Fluid, Loss Of Fluid, loss of vitreous|Loss of vitreous fluid C36283 Eye and Ear Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50640 2477 Oxygen Saturation, Low Saturation, low oxygen|Low oxygen saturation The calculated measurements indicating the degree to which oxygen is bound to hemoglobin is low. A low level of the degree to which oxygen is bound to hemoglobin given as a percentage calculated by dividing the maximum oxygen capacity into the actual oxygen content and multiplying by 100. Oxygen saturation usually is measured using pulse oximetry. C5044 Fluid and Electrolyte Manifestation FDA C54450 Patient_Problem_Codes_FDA_CDRH C50641 2501 Low Cardiac Output Cardiac output, low|Output, low cardiac C35552 Cardiovascular System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50642 2479 Pulmonary Arterial Wedge Pressure, Low Arterial wedge pressure, low pulmonary|Pressure, low pulmonary arterial wedge|Wedge pressure, low pulmonary arterial|Low pulmonary arterial wedge pressure The measurement of the mean left pulmonary arterial pressure, as measured by a catheter introduced into the distal pulmonary artery, is low. The measurement of the mean left pulmonary arterial pressure, as measured by a catheter introduced into the distal pulmonary artery, is low. C35552 Cardiovascular System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50643 2186 Headache, Lumbar Puncture Headache, post spinal|Lumbar puncture headache|Post spinal headache Headache in erect position, after lumbar puncture; due to lowering of intracranial pressure by leakage of cerebrospinal fluid through the needle tract. Headache in erect position, after lumbar puncture; due to lowering of intracranial pressure by leakage of cerebrospinal fluid through the needle tract. C52681 Adverse Event by Cause FDA C54450 Patient_Problem_Codes_FDA_CDRH C50644 2397 Lung, Overinflation Of Overinflation of lung Abnormal permanent enlargement of the lung air spaces distal to terminal bronchiole not resulted from wall destruction, e.g. due to loss of opposite lung. C45233 Respiratory System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50645 2198 Mediastinal Shift Shift, mediastinal Normal location of the mediastinum changes to the right or left, depending upon the underlying cause. C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50647 1204 Vessel Or Plaque, Device Embedded In Device embedded in vessel or plaque|Plaque or vessel, device embedded in Device and/or fragments of device are embedded in patient's vessel and/or plaque. C34620 Foreign body FDA C54450 Patient_Problem_Codes_FDA_CDRH C50652 2215 Abortion, Missed Retention in uterus of an abortus that has been dead at least 4 weeks. Retention in uterus of an abortus that has been dead at least 4 weeks. C34941 Pregnancy Complication FDA C54450 Patient_Problem_Codes_FDA_CDRH C50653 2512 Mitral Perforation Perforation, mitral C45430 Heart Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C50654 1965 Mitral Stenosis Stenosis, mitral Narrowing of the left atrioventricular mitral orifice. Narrowing of the left atrioventricular mitral orifice. C62433 Valvular Stenosis FDA C54450 Patient_Problem_Codes_FDA_CDRH C50655 2471 Mitral Valve Prolapse Prolapse, mitral valve|Valve, prolapse of mitral Prolapse of the mitral valve, often with regurgitation, associated with myxomatous proliferation of the leaflets of the mitral valve. A fairly common and often benign valvular heart disorder characterized by redundancy or hooding of mitral valve leaflets so that they prolapse into the left atrium, often causing mitral regurgitation. It is often a symptomless condition but may be marked by varied symptoms (e.g. chest pain, fatigue, dizziness, dyspnea, or palpitations) leading in some cases to endocarditis or ventricular tachycardia. C36173 2475 Prolapse FDA C54450 Patient_Problem_Codes_FDA_CDRH C50656 1966 Muscle Spasm(s) Spasm(s), muscle) A sudden, violent, involuntary contraction of a muscle or group of muscles. A sudden, violent, involuntary contraction of a muscle or group of muscles. C36288 Connective and Soft Tissue Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50657 1412 Muscle Stimulation Stimulation of muscle C36288 Connective and Soft Tissue Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50658 1967 Muscle Weakness Weakness, muscular A reduction in the strength of one or more muscles. C36288 Connective and Soft Tissue Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50659 1968 Muscular Rigidity Rigidity, muscular Stiffness or inflexibility. Stiffness or inflexibility. C36288 Connective and Soft Tissue Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50660 2161 Muscular Tics An involuntary, compulsive, repetitive stereotyped movement, usually of the face or shoulders. An involuntary, compulsive, repetitive stereotyped movement, usually of the face or shoulders. C3837 Neurological Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C50661 1763 Myocardial Contusion Cardiac contusion|Contusion, myocardial|Contusion, cardiac A bruise to the heart. A bruise to the heart. C50441 1787 Contusion FDA C54450 Patient_Problem_Codes_FDA_CDRH C50662 2466 Nasal Obstruction Obstruction, nasal C3284 2422 Obstruction FDA C54450 Patient_Problem_Codes_FDA_CDRH C50663 2433 Pain, Neck Neck pain C3303 1994 Pain FDA C54450 Patient_Problem_Codes_FDA_CDRH C50664 2434 Stiffness, Neck Neck stiffness C36282 Head and Neck Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50665 2462 Needle Stick/Puncture Puncture/stick from needle|Stick/puncture from needle A penetrating stab wound from a needle (or other sharp object) that may result in exposure to blood or other body fluids. C34948 Puncture Wound FDA C54450 Patient_Problem_Codes_FDA_CDRH C50666 1974 Neonatal Deformities Deformities, neonatal C2849 1782 Congenital Defect/Deformity FDA C54450 Patient_Problem_Codes_FDA_CDRH C50667 1975 Neonatal Hearing Impairment Hearing impairment, neonatal|Impairment to hearing, neonatal C2849 1782 Congenital Defect/Deformity FDA C54450 Patient_Problem_Codes_FDA_CDRH C50668 1976 Neonatal Hearing Loss Hearing loss, neonatal|Loss of hearing, neonatal C2849 1782 Congenital Defect/Deformity FDA C54450 Patient_Problem_Codes_FDA_CDRH C50669 1979 Nerve Damage Damage to nerve(s) C4974 Nervous System Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C50671 2265 Shock, Neurogenic Neurogenic shock 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. 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. C35016 2072 Shock FDA C54450 Patient_Problem_Codes_FDA_CDRH C50672 1982 Neurological Deficit/Dysfunction Deficit/dysfunction, neurological|Dysfunction/deficit, neurological C36280 Nervous System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50673 2162 Nipple Sensation, Changes In/Loss Of Changes in/loss of nipple sensation|Sensation, changes in/loss of nipple|Loss of/changes in nipple sensation C5040 Sensory Manifestations FDA C54450 Patient_Problem_Codes_FDA_CDRH C50674 2441 Nipple Ulceration Ulceration, nipple C2909 Non-Neoplastic Breast Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50675 2199 No Consequences Or Impact To Patient Consequences or impact to patient, none|Patient, no consequences or impact to|Impact or consequences to patient, none C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50677 2481 Pulmonary Arterial Wedge Pressure, Normal Arterial wedge pressure, normal pulmonary|Wedge pressure, normal pulmonary arterial|Normal pulmonary arterial wedge pressure|Pressure, normal pulmonary arterial wedge The measurement of the mean left arterial pressure, as measured by a catheter introduced into the distal pulmonary artery, is normal. The measurement of the mean left arterial pressure, as measured by a catheter introduced into the distal pulmonary artery, is normal. C35552 Cardiovascular System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50678 1984 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. Obstruction or a closure of hollow organ, passageway or vessel; also the transient approximation of the edges of a natural opening; imperforation. C3284 2422 Obstruction FDA C54450 Patient_Problem_Codes_FDA_CDRH C50679 1987 Organ(s), Perforation Of Perforation of organ(s) C4080 2001 Perforation FDA C54450 Patient_Problem_Codes_FDA_CDRH C50680 1428 Ossification The formation of bone or of a bony substance; the conversion of fibrous tissue or of cartilage into bone or a bony substance. The formation of bone or of a bony substance; the conversion of fibrous tissue or of cartilage into bone or a bony substance. C36288 Connective and Soft Tissue Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50681 2377 Osteolysis Dissolution of bone; applied especially to the removal or loss of the calcium of bone. Dissolution of bone; applied especially to the removal or loss of the calcium of bone. C27572 Non-Neoplastic Bone Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50683 1991 Overstimulation C20181 Conceptual Entity FDA C54450 Patient_Problem_Codes_FDA_CDRH C50685 2468 Pallor An unusual or extreme paleness, state of decreased skin coloration. C36281 Integumentary System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50686 1447 Pannus Formation Formation, pannus 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. 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. C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50687 2448 Paraplegia Paralysis of the legs and lower part of the body. Complete paralysis of the lower half of the body including both legs, often caused by damage to the spinal cord. C27588 Non-Neoplastic Nervous System Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50688 1998 Paresis A slight or incomplete paralysis. A slight or incomplete paralysis. C3310 1997 Paralysis FDA C54450 Patient_Problem_Codes_FDA_CDRH C50689 2260 Seizures, Focal Focal seizuresl Partial seizure. A transitory alteration in movement, sensation or autonomic nerve function due to abnormal electric activity in a localized area of the cerebral cortex, usually without change in awareness or alertness. Symptoms vary with different lesion locations and may include but not limited to the motor (e.g. rhythmic muscle contractions in one area of the body), somatosensory and sensory alterations manifested by abnormal numbness, paresthesias or other hallucinations, including several types of aura; autonomic and psychic symptoms, e.g. with changes in speech, thought, personality, mood, sensation of deja vu or hallucinations. C2962 2063 Seizures FDA C54450 Patient_Problem_Codes_FDA_CDRH C50691 1999 Peeling A peeling off or loss of epidermis, as in sunburn, postscarlatinal peeling, or toxic epidermal necrolysis. A peeling off or loss of epidermis, as in sunburn, postscarlatinal peeling, or toxic epidermal necrolysis. C5036 Integumentary System Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C50692 1792 Cornea, Perforation Of Perforation of cornea C27608 Non-Neoplastic Corneal Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50693 2399 Esophagus, Perforation Of Perforation of esophagus The presence of a hole or other type of opening in the esophageal wall through which the contents of the esophagus can pass into the mediastinum. The most common cause of esophageal perforation is injury during a medical procedure such as esophagoscopy or placement of a naso-gastric tube; and pathologic process such as neoplasm or gastric reflux with ulceration. Less common causes include injuries from penetrating or blunt trauma or injury to the esophagus during an operation on another organ, mechanical problem such as violent retching or vomiting; ingestion of a foreign body or caustic agents. The condition often results in infection of the mediastinum and mediastinitis. C35328 Injury to Esophagus FDA C54450 Patient_Problem_Codes_FDA_CDRH C50694 2002 Peripheral Vascular Disease Disease, peripheral vascular|Vascular disease, peripheral C35740 Non-Neoplastic Vascular Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50695 2003 Peritoneal Laceration(s) Laceration(s), peritoneal C34332 Abdominal Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C50697 2164 Phosphene Visualization Visualization, phosphene An objective visual sensation that appears with the eyes closed and in the absence of visual light. An objective visual sensation that appears with the eyes closed and in the absence of visual light. C5042 Visual Manifestations FDA C54450 Patient_Problem_Codes_FDA_CDRH C50698 2165 Phototoxicity A nonimmunologic, chemically induced type of photosensitivity. A nonimmunologic, chemically induced type of photosensitivity. C38004 Photosensitivity FDA C54450 Patient_Problem_Codes_FDA_CDRH C50699 2013 Pocket Erosion Erosion, pocket Erosion of patient's skin pocket which houses a device. Erosion of patient's skin pocket which houses a device. C50443 1750 Erosion FDA C54450 Patient_Problem_Codes_FDA_CDRH C50700 2604 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. 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. C4876 Symptom FDA C54450 Patient_Problem_Codes_FDA_CDRH C50701 2015 Positive antinuclear antibodies (ANA) ANA, positive antinuclear antibodies|Antinuclear antibodies (ANA), positive|Antibodies (ANA), positive antinuclear 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. Indicates that antibodies directed against nuclear antigens have been detected. C38440 Abnormal Immunology Test Result FDA C54450 Patient_Problem_Codes_FDA_CDRH C50702 2639 Capsular Bag Tear, Posterior C2959 Complication FDA C54450 Patient_Problem_Codes_FDA_CDRH C50703 2266 Shock, Postoperative Postoperative shock A state of shock following a surgical operation. A state of shock following a surgical operation. C35019 2267 Shock, Surgical FDA C54450 Patient_Problem_Codes_FDA_CDRH C50704 2446 Wound Infection, Post-Operative Infection, post-operative wound|Post-operative wound infection C35050 Surgical Wound Infection FDA C54450 Patient_Problem_Codes_FDA_CDRH C50705 2447 Wound Infection, Post-Traumatic Infection, post-traumatic wound|Post-traumatic wound infection C45234 Wound Infection FDA C54450 Patient_Problem_Codes_FDA_CDRH C50706 2326 Pressure Sores/Ulcers Necrosis, Pressure|Pressure, necrosis|Ulcers/sores, pressure|Sores/ulcers, pressure Death of tissue due to external pressure. Death of tissue due to external pressure. C3426 2274 Ulcer FDA C54450 Patient_Problem_Codes_FDA_CDRH C50707 2655 Disc Impingement C35552 Cardiovascular System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50711 2605 Pseudoaneurysm C35552 Cardiovascular System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50712 2019 Pulmonary Dysfunction Dysfunction, pulmonary C45233 Respiratory System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50713 1498 Pulmonary Embolism Embolism, pulmonary The closure of the pulmonary artery or one of its branches by an embolus, sometimes associated with infarction of the lung. The closure of the pulmonary artery or one of its branches by an embolus, sometimes associated with infarction of the lung. C26759 1829 Embolism FDA C54450 Patient_Problem_Codes_FDA_CDRH C50714 2021 Pulmonary Infarction Infarction, pulmonary Localized necrosis of lung tissue caused by obstruction of the arterial blood supply, most often due to pulmonary embolism. Localized necrosis of lung tissue caused by obstruction of the arterial blood supply, most often due to pulmonary embolism. C27557 Non-Neoplastic Lung Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50715 2024 Pulmonary Stenosis Stenosis, pulmonary Narrowing of the opening between the pulmonary artery and the right ventricle, usually at the level of the valve leaflets. Narrowing of the opening between the pulmonary artery and the right ventricle, usually at the level of the valve leaflets. C62433 Valvular Stenosis FDA C54450 Patient_Problem_Codes_FDA_CDRH C50716 2026 Pupillary Block Block, pupillary An obstruction of the pupil. An obstruction of the pupil. C36283 Eye and Ear Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50717 1812 Purulent discharge Discharge, purulent Consisting of or containing pus; associated with the formation of or caused by pus. Consisting of or containing pus; associated with the formation of or caused by pus. C34548 Fluid Discharge FDA C54450 Patient_Problem_Codes_FDA_CDRH C50719 2246 Infection, Pyrogenic Pyrogenic infection An infection caused by pus-producing organisms. An infection caused by pus-producing organisms. C26726 1930 Infection FDA C54450 Patient_Problem_Codes_FDA_CDRH C50721 2449 Quadriplegia Paralysis of all four limbs. Paralysis of all four limbs. C27588 Non-Neoplastic Nervous System Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50722 1755 Radiation burn Burn, Radiation A burn caused by exposure to x-ray, radium, sunlight, atomic or any other type of radiant energy. A burn caused by exposure to x-ray, radium, sunlight, atomic or any other type of radiant energy. C34441 1757 Burn(s) FDA C54450 Patient_Problem_Codes_FDA_CDRH C50723 2256 Radiation Sickness Syndrome Syndrome, radiation sickness|Sickness syndrome, radiation Radiation induced skin desquamation The complex of symptoms characterizing the disease known as radiation injury, resulting from excessive exposure (greater than 200 rads or 2 gray) of the whole body (or large part) to ionizing radiation. The earliest of these symptoms are nausea, fatigue, vomiting, and diarrhea, which may be followed by epilation, hemorrhage, inflammation of the mouth and throat, and general loss of energy. In severe cases, where the radiation exposure has been approximately 1000 Rad (10 gray) or more, death may occur within two to four weeks. Those who survive six weeks after the receipt of a single large dose of radiation to the whole body may generally be expected to recover. (U.S. Nuclear Regulatory Commission). C53539 Radiation-Related Non-Neoplastic Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50724 2034 Raynauds Phenomenon Phenomenon, Raynauds 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. A set of symptoms characteristic of peripheral vascular disease, namely caused by an inappropriate response of the peripheral arteries in reaction to environmental stimuli, usually to the cold. The term is used when an underlying disease (mostly connective tissue/autoimmune disorders such as lupus, scleroderma, rheumatoid arthritis, etc.) is primarily causative and a range of symptoms including the peripheral vascular spasm is secondary. The term does not refer to the primary Raynauds or Raynauds disease. C35136 Peripheral Vascular Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50725 2038 Red Eye(s) Eye(s), red Lay term applied to any condition with dilation of conjunctival or ciliary blood vessels; innumerable causes, especially irritation and infection. Lay term applied to any condition with dilation of conjunctival or ciliary blood vessels; innumerable causes, especially irritation and infection. C36283 Eye and Ear Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50726 2259 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. 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. C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50727 1985 Reocclusion C35552 Cardiovascular System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50728 2482 Respiratory Acidosis Acidosis, Respiratory A state due to excess retention of carbon dioxide in the body. Acidosis resulted from any pathologic condition interfering with normal ventilation, e.g. in case of chronic obstructive pulmonary disease. C45233 Respiratory System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50729 2483 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. Condition characterized by excessive loss of carbon dioxide from the body, often as a result of hyperventilation due to psychogenic or physical factors. C45233 Respiratory System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50731 2048 Retina, Damage To Damage to retina C34602 1845 Eye injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C50732 2050 Retina, Tear(s) In C50731 2048 Retina, Damage To FDA C54450 Patient_Problem_Codes_FDA_CDRH C50733 2054 Right Ventricular Dysfunction Dysfunction, right ventricular C35552 Cardiovascular System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50734 2056 Right Ventricular Hypertrophy Hypertrophy, right ventricular|Ventricular hypertrophy, right Enlargement or overgrowth of the myocardium of the right ventricle, due chronic pressure overload. Enlargement or overgrowth of the myocardium of the right ventricle, due chronic pressure overload. C35552 Cardiovascular System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50737 2060 Scar Tissue Cicatrix|Tissue, scar Formation of new tissue formed in the healing of a wound. Formation of new tissue formed in the healing of a wound. C27549 Reactive Cutaneous Fibrous Lesion FDA C54450 Patient_Problem_Codes_FDA_CDRH C50739 2069 Seroma A tumor-like collection of serum in the tissues. A tumor-like collection of serum in the tissues. C35867 Morphologic Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50741 2277 Sinus, Perforation Of Perforation of sinus C4080 2001 Perforation FDA C54450 Patient_Problem_Codes_FDA_CDRH C50743 2076 Skin Irritation Irritation of skin A mild inflammatory dermal tissue reaction; it can be caused by physical contact with an irritant or can be a local response to a systemic trigger. C5036 Integumentary System Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C50744 2516 Skin Tears C5036 Integumentary System Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C50745 2077 Fracture, Skull Skull fracturel C3046 1870 Fracture(s) FDA C54450 Patient_Problem_Codes_FDA_CDRH C50746 2251 Sneezing A symptom consisting of the involuntary expulsion of air from the nose. C4876 Symptom FDA C54450 Patient_Problem_Codes_FDA_CDRH C50747 2396 Sore Throat Throat, sore Any kind of inflammatory process of the tonsils, pharynx, or/and larynx characterized by pain in swallowing. C27660 Non-Neoplastic Neck Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50749 2390 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. A chronic adhesive arachnoiditis in the spinal arachnoid, with root and spinal cord symptoms similar to those caused by pressure from a tumor. C37913 Arachnoiditis FDA C54450 Patient_Problem_Codes_FDA_CDRH C50750 2432 Spinal Cord Injury Injury, spinal cord C4974 Nervous System Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C50751 2081 Spinal Injury Injury, spinal C3671 2348 Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C50752 1593 Stacking Breaths Breaths, stacking Condition where there are a greater number of inhalations relative to the number of exhalations. Condition where there are a greater number of inhalations relative to the number of exhalations. C3676 Alteration in Respiration FDA C54450 Patient_Problem_Codes_FDA_CDRH C50754 2263 Stenosis Stricture Narrowing or stricture of a duct or canal. Narrowing or stricture of a duct or canal. C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50756 2084 Strangulation Chocking or arrest of respiration due to occlusion of the air passageway; arrest of circulation in a part due to compression. Chocking or arrest of respiration due to occlusion of the air passageway; arrest of circulation in a part due to compression. C3671 2348 Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C50757 1893 Hemorrhage, Subarachnoid Subarachnoid hemorrhage Intracranial hemorrhage into the subarachnoid space. Intracranial hemorrhage into the subarachnoid space. C26791 1888 Hemorrhage FDA C54450 Patient_Problem_Codes_FDA_CDRH C50758 2247 Infection, Subclinical Subclinical infection Infection associated with no detectable symptoms but caused by microorganisms capable of producing easily recognizable diseases, such a poliomyelitis or mumps. Infection associated with no detectable symptoms but caused by microorganisms capable of producing easily recognizable diseases, such a poliomyelitis or mumps. C26726 1930 Infection FDA C54450 Patient_Problem_Codes_FDA_CDRH C50759 1894 Hemorrhage, Subdural Subdural hemorrhage Cerebral hemorrhage into the subdural space. See also Stroke Syndrome. Cerebral hemorrhage into the subdural space. See also Stroke Syndrome. C26791 1888 Hemorrhage FDA C54450 Patient_Problem_Codes_FDA_CDRH C50760 2087 Subepithelial Infiltration Infiltration, subepithelial C35867 Morphologic Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50761 2603 Hemorrhage, Subgaleal Hemorrhage, subgaleal C26791 1888 Hemorrhage FDA C54450 Patient_Problem_Codes_FDA_CDRH C50762 2088 Suffocation The stopping of respiration or the asphyxia that results from it. The stopping of respiration or the asphyxia that results from it. C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50763 2089 Sunset Syndrome Syndrome, sunset Decentration, or malposition of intraocular lens; zonular dehiscence or lens malposition caused by zonular or parsplana fixation. Decentration, or malposition of intraocular lens; zonular dehiscence or lens malposition caused by zonular or parsplana fixation. C27604 Non-Neoplastic Eye Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50764 2092 Swollen Glands Glands, swollen C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50765 2093 Swollen Lymph Nodes Lymph nodes, swollen|Nodes, swollen lymph C36289 Hematopoietic System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50766 2094 Synovitis Inflammation of a synovial membrane. Inflammation of a synovial membrane. C36288 Connective and Soft Tissue Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50767 2486 Respiratory Rate, Increased Increased respiratory rate|Rate of respiration, increased Abnormal increase of rate of breathing. C3676 Alteration in Respiration FDA C54450 Patient_Problem_Codes_FDA_CDRH C50768 2530 Burn, thermal Thermal burn|Burns, Thermal C34441 1757 Burn(s) FDA C54450 Patient_Problem_Codes_FDA_CDRH C50770 2102 Thyroid Problems Problems, thyroid C36285 Endocrine System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50771 2171 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. 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. C34549 Disturbance of Skin Sensation FDA C54450 Patient_Problem_Codes_FDA_CDRH C50772 2103 Tinnitus Ears, ringing in|Ringing in ears A noise in the ears, such as ringing, buzzing, roaring, clicking. A noise in the ears, such as ringing, buzzing, roaring, clicking. C5037 Alterations in Hearing FDA C54450 Patient_Problem_Codes_FDA_CDRH C50773 2104 Tissue Damage Damage, tissue C3671 2348 Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C50776 2223 Convulsion, Tonic Tonic convulsion Prolonged contraction of the muscles, as the result of an epileptic discharge. Prolonged contraction of the muscles, as the result of an epileptic discharge. C3837 Neurological Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C50777 2428 Fracture, Tooth Tooth fracture Broken tooth affecting any portion of tooth: root fracture, crown-root, broken tooth (crown fracture), chipped tooth. A crown fracture can involve the pulp. Tooth fracture sequelae range in severity from cosmetic defects to tooth death. Involvement of the pulp is a more important indicator of severity of tooth fracture than is the amount of the tooth affected. C3671 2348 Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C50778 2427 Teeth, Sensitivity Of Sensitivity Of Tooth C60925 Oral Cavity Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50779 2107 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. '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. C50802 2132 Ventricular Tachycardia FDA C54450 Patient_Problem_Codes_FDA_CDRH C50780 2207 Toxemia The condition resulting from the spread of bacterial products (toxins) by the bloodstream. The condition resulting from the spread of bacterial products (toxins) by the bloodstream. C26726 1930 Infection FDA C54450 Patient_Problem_Codes_FDA_CDRH C50781 2109 Transient Ischemic Attack Attack, transient ischemic|Ischemic attack, transient A brief attack (from a few minutes to an hour) of cerebral dysfunction of vascular origin, with no persistent neurological deficit. A brief attack (from a few minutes to an hour) of cerebral dysfunction of vascular origin, with no persistent neurological deficit. C2938 Cerebrovascular Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50782 2268 Shock, Traumatic Traumatic shock Any shock produced by trauma. Any shock produced by trauma. C35016 2072 Shock FDA C54450 Patient_Problem_Codes_FDA_CDRH C50783 2113 Tricuspid Stenosis Stenosis, tricuspid Narrowing or stricture of the tricuspid orifice of the heart. Narrowing or stricture of the tricuspid orifice of the heart. C62433 Valvular Stenosis FDA C54450 Patient_Problem_Codes_FDA_CDRH C50784 2114 Twiddlers Syndrome Syndrome, twiddler's 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. 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. C28193 Syndrome FDA C54450 Patient_Problem_Codes_FDA_CDRH C50785 2172 Twitching The occurrence of a single contraction or a series of contractions of a muscle. The occurrence of a single contraction or a series of contractions of a muscle. C3837 Neurological Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C50786 1936 Intraocular Pressure, Delayed, Uncontrolled Delayed, uncontrolled intraocular pressure (IOP)|Uncontrolled/delayed intraocular pressure (IOP)|Pressure (IOP), delayed uncontrolled intraocular|Intraocular pressure (IOP), delayed, uncontrolled|IOP Delayed, Uncontrolled|IOP (intraocular pressure), delayed, uncontrolled Changes in the fluid pressure inside the eye. C36283 Eye and Ear Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50787 1980 Nerve Stimulation, Undesired Undesired nerve stimulation|Stimulation of nerve, undesired C3837 Neurological Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C50789 2099 Therapeutic Effects, Unexpected Effects, unexpected therapeutic|Unexpected therapeutic effects C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50790 2119 Urinary Retention Retention, urinary Accumulation of urine within the bladder because of the inability to urinate. Accumulation of urine within the bladder because of the inability to urinate. C36286 Urinary Tract Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50791 2120 Infection, Urinary Tract Tract, infection of urinary|Urinary tract infection C35719 Genitourinary System Infection FDA C54450 Patient_Problem_Codes_FDA_CDRH C50792 1871 Micturation urgency Urgency A sudden compelling urge to urinate. A sudden compelling urge to urinate. C5035 Genitourinary Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C50793 2121 Uterine Perforation Perforation of uterus C4080 2001 Perforation FDA C54450 Patient_Problem_Codes_FDA_CDRH C50794 2115 UGH (Uveitis-Glaucoma-Hyphema) Syndrome Syndrome, uveitis-glaucoma-hyphema (UGH)|Uveitis-glaucoma-hyphema (UGH) syndrome For complications that occur secondary to intraocular lens implantation in the anterior chamber; caused by rubbing of the lens loop (haptics). Clinical triad of uveitis, glaucoma, and hyphema (UGH), especially associated with the early anterior chamber intraocular lens (IOL).Glaucoma is believed to be caused by movement of the IOL against the iris causing release of inflammatory and red blood cell debris, which obstruct the trabecular meshwork. The haptic also may cause direct damage to the trabecular meshwork contributing to the glaucoma. Incidence of UGH is dependent on both surgical methodology applied in the cataract population and type of IOL used. UGH is particularly common if metal clip lenses have been used. Components of the condition may be reversed if the offending IOL is removed before permanent damage has occurred. C27604 Non-Neoplastic Eye Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50795 2123 Vaginal Discharge Discharge, vaginal C36284 Reproductive System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50796 1926 Insufficiency, Valvular Valvular insufficiency Dysfunction of one of the cardiac valves, with incomplete valve closure resulting in valvular regurgitation. Dysfunction of one of the cardiac valves, with incomplete valve closure resulting in valvular regurgitation. C45525 Valvular Heart Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50797 2335 Regurgitation, Valvular Valvular regurgitation Regurgitation of the blood of the heart valves owning to imperfect closing, insufficiency or incompetency of the valves. Regurgitation of the blood of the heart valves owning to imperfect closing, insufficiency or incompetency of the valves. C45525 Valvular Heart Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50798 2661 Vaso-Vagal Response C3837 Neurological Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C50799 2130 Ventricular Fibrillation Fibrillation, ventricular Arrhythmia characterized by fibrillary contractions of the ventricular muscle due to rapid repetitive excitation of myocardial fibers without coordinated contraction of the ventricle. Arrhythmia characterized by fibrillary contractions of the ventricular muscle due to rapid repetitive excitation of myocardial fibers without coordinated contraction of the ventricle. C26924 Ventricular Arrhythmia FDA C54450 Patient_Problem_Codes_FDA_CDRH C50800 2131 Ventricular Flutter Flutter, ventricular A ventricular tachyarrhythmia characterized electrocardiographically by smooth undulating waves with QRS complexes merged with T waves, a rate of approximately 250 per minute. A ventricular tachyarrhythmia characterized electrocardiographically by smooth undulating waves with QRS complexes merged with T waves, a rate of approximately 250 per minute. C50802 2132 Ventricular Tachycardia FDA C54450 Patient_Problem_Codes_FDA_CDRH C50802 2132 Ventricular Tachycardia An abnormally rapid ventricular rhythm with aberrant ventricular excitation, usually in excess of 150 beats per minute. A tachycardia arising distal to bundle of His, with a rate greater than 100 beats per minute. C26924 Ventricular Arrhythmia FDA C54450 Patient_Problem_Codes_FDA_CDRH C50803 2133 Cerebral ventriculomegalia Ventriculomeglia C50448 2078 Ventricle, Abnormality Of FDA C54450 Patient_Problem_Codes_FDA_CDRH C50804 2135 Vessels, Perforation Of Perforation of vessel(s) C35552 Cardiovascular System Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50805 2140 Visual Disturbances Disturbances, visual C5042 Visual Manifestations FDA C54450 Patient_Problem_Codes_FDA_CDRH C50806 2227 Halo Hazy ring around bright lights seen by some patients with refractive error or optical defects, e.g. cataracts, or corneal swelling. Hazy ring around bright lights seen by some patients with refractive error or optical defects, e.g. cataracts, or corneal swelling. C27123 2137 Blurred vision FDA C54450 Patient_Problem_Codes_FDA_CDRH C50807 2445 Vitreous, Detachment Of Detachment of vitreous C27604 Non-Neoplastic Eye Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50808 1866 Vitreous floaters Floaters, Vitreous 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. A blurry spot that appears to float around in the eye but does not block vision. The blur is the result of debris from the vitreous humour casting a shadow on the retina. C36283 Eye and Ear Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50809 2145 Weakness C3858 Mental and Behavioral Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C50810 2607 Weight Fluctuations Fluctuations of weight C9232 Weight Change FDA C54450 Patient_Problem_Codes_FDA_CDRH C50811 2241 Wheal(s) Welt(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. 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. C5036 Integumentary System Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C50815 2472 Aortic Valve Replacement Valve, replacement of aortic|Replacement of aortic valve Surgery performed with the purpose of replacing a degenerated, calcified, malformed, dysfunctional, etc. aortic valve with a bioprosthetic, homograft, or autograft valve. C49803 Cardiovascular Surgical Procedure FDA C54450 Patient_Problem_Codes_FDA_CDRH C50816 2473 Tricuspid Valve Replacement Replacement of tricuspid valve|Valve, replacement of tricuspid Surgery performed with the purpose of replacing a degenerated, calcified, malformed, dysfunctional, etc. tricuspid valve with bioprosthetic, homograft or autograft valve. C49803 Cardiovascular Surgical Procedure FDA C54450 Patient_Problem_Codes_FDA_CDRH C50817 2474 Pulmonary Valve Replacement Valve, replacement of pulmonary|Replacement of pulmonary valve Surgery performed with the purpose of replacing a degenerated, calcified, malformed, dysfunctional, etc. pulmonary valve with bioprosthetic, homograft or autograft valve. C49803 Cardiovascular Surgical Procedure FDA C54450 Patient_Problem_Codes_FDA_CDRH C50819 2402 Extubate The removal of a previously inserted tube from a hollow organ or passageway, often from the airway. C49236 Therapeutic Procedure FDA C54450 Patient_Problem_Codes_FDA_CDRH C50820 2403 Reinfusion The infusion of autogenic body fluid that has previously been withdrawn from the patient. C15388 Infusion Procedure FDA C54450 Patient_Problem_Codes_FDA_CDRH C50821 2365 Foreign Body, Removal Of Removal of foreign body C49236 Therapeutic Procedure FDA C54450 Patient_Problem_Codes_FDA_CDRH C50822 2400 Resuscitation The measures applied for the restoration a person to life and/or consciousness. The act of resuscitation includes such components as artificial respiration and cardiac massage. C49236 Therapeutic Procedure FDA C54450 Patient_Problem_Codes_FDA_CDRH C50823 2177 Surgery, Prolonged Prolonged surgery C15329 2357 Surgical Procedure FDA C54450 Patient_Problem_Codes_FDA_CDRH C50824 2372 Apicectomy Excision of the apex of the petrous portion of the temporal bone. C51917 Excision of Bone FDA C54450 Patient_Problem_Codes_FDA_CDRH C50825 2376 Mitral Valve Replacement Valve replacement, mitral|Replacement, mitral valve Surgery performed with the purpose of replacing a degenerated, calcified, malformed, dysfunctional, etc. mitral valve with bioprosthetic, homograft or autograft valve. C49803 Cardiovascular Surgical Procedure FDA C54450 Patient_Problem_Codes_FDA_CDRH C50827 2358 Scar Excision Excision, scar C15232 Excision FDA C54450 Patient_Problem_Codes_FDA_CDRH C50828 2392 Reintubate C37981 2559 Intubation FDA C54450 Patient_Problem_Codes_FDA_CDRH C50830 2042 Surgical Procedure, Repeated Procedure repeated, surgical|Surgical procedure, repeated C15329 2357 Surgical Procedure FDA C54450 Patient_Problem_Codes_FDA_CDRH C50831 2564 Surgical Procedure, Additional Procedure, additional surgical Any surgical procedure performed subsequent to a primary or initial surgical procedure. C15329 2357 Surgical Procedure FDA C54450 Patient_Problem_Codes_FDA_CDRH C50832 1749 Transfusion with incompatible blood Blood, transfusion with incompatible|Incompatible blood, transfusion with C15192 2337 Transfusion Of Blood Products FDA C54450 Patient_Problem_Codes_FDA_CDRH C50833 2566 Surgical Procedure, Unnecessary Procedure, unnecessary surgical C15329 2357 Surgical Procedure FDA C54450 Patient_Problem_Codes_FDA_CDRH C50834 2626 Closed Capsulotomy C49236 Therapeutic Procedure FDA C54450 Patient_Problem_Codes_FDA_CDRH C50836 2641 Lens, Replacement Of C15331 Ophthalmologic Surgical Procedure FDA C54450 Patient_Problem_Codes_FDA_CDRH C50837 2643 Vitrectomy C15331 Ophthalmologic Surgical Procedure FDA C54450 Patient_Problem_Codes_FDA_CDRH C50839 2406 Identified Diagnosis Diagnosis, identified The identification of a disease by its signs, symptoms and results of various diagnostic procedures. The final conclusion reached through this process is called an established diagnosis. C15220 Diagnosis FDA C54450 Patient_Problem_Codes_FDA_CDRH C50841 2398 Esophagus, Laceration(s) Of Laceration(s) of esophagus A torn, ragged, mangled wound, or an accidental cut of esophagus. C35328 Injury to Esophagus FDA C54450 Patient_Problem_Codes_FDA_CDRH C50842 2111 Tricuspid Insufficiency Insufficiency, tricuspid Incomplete closure of the tricuspid valve, resulting in tricuspid regurgitation; it is usually secondary to systolic overload in the right ventricle. Incomplete closure of the tricuspid valve, resulting in tricuspid regurgitation; it is usually secondary to systolic overload in the right ventricle. C50796 1926 Insufficiency, Valvular FDA C54450 Patient_Problem_Codes_FDA_CDRH C50843 2112 Tricuspid Regurgitation Regurgitation, tricuspid The backflow of blood from the right ventricle into the right atrium, owning to imperfect functioning/insufficiency of the tricuspid valve. The backflow of blood from the right ventricle into the right atrium, owning to imperfect functioning/insufficiency of the tricuspid valve. C50797 2335 Regurgitation, Valvular FDA C54450 Patient_Problem_Codes_FDA_CDRH C50844 2097 Tentorial Tears Tears, tentorial Pertaining to tears involving the tentorium of the cerebellum. Pertaining to tears involving the tentorium of the cerebellum. C50440 2219 Brain Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C50845 2075 Skin Erosion Erosion, skin A gradual breakdown or very shallow ulceration of the skin which involves only the epidermis and heals without scarring. A gradual breakdown or very shallow ulceration of the skin which involves only the epidermis and heals without scarring. C50443 1750 Erosion FDA C54450 Patient_Problem_Codes_FDA_CDRH C50846 2055 Right Ventricular Failure Failure, right ventricular|Ventricular failure, right Failure of proper functioning of the right ventricle, with venous engorgement, hepatic enlargement, and subcutaneous edema. Failure of proper functioning of the right ventricle, with venous engorgement, hepatic enlargement, and subcutaneous edema. C50733 2054 Right Ventricular Dysfunction FDA C54450 Patient_Problem_Codes_FDA_CDRH C50847 2064 Seizures, Focal Motor Focal motor seizures 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. 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. C50689 2260 Seizures, Focal FDA C54450 Patient_Problem_Codes_FDA_CDRH C50848 2023 Pulmonary Regurgitation Regurgitation, pulmonary The backflow of blood from the pulmonary artery into the right ventricle, owing to insufficiency of the pulmonic semilunar valve. The backflow of blood from the pulmonary artery into the right ventricle, owing to insufficiency of the pulmonic semilunar valve. C50797 2335 Regurgitation, Valvular FDA C54450 Patient_Problem_Codes_FDA_CDRH C50849 1986 Optical Nerve Damage Damage to optical nerve(s)|Nerve damage, optical C50669 1979 Nerve Damage FDA C54450 Patient_Problem_Codes_FDA_CDRH C50850 1990 Oversedated C50874 Overmedicated FDA C54450 Patient_Problem_Codes_FDA_CDRH C50852 1964 Mitral Regurgitation Regurgitation, mitral 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. 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. C50797 2335 Regurgitation, Valvular FDA C54450 Patient_Problem_Codes_FDA_CDRH C50853 1953 Liver Contusion Contusion, liver Bruising of the liver. Bruising of the liver. C50441 1787 Contusion FDA C54450 Patient_Problem_Codes_FDA_CDRH C50854 1955 Liver Laceration(s) Laceration(s), liver C35241 Injury to Liver FDA C54450 Patient_Problem_Codes_FDA_CDRH C50856 1841 Exsanguination Extensive loss of blood due to internal or external hemorrhage. Extensive loss of blood due to internal or external hemorrhage. C50470 2597 Blood loss FDA C54450 Patient_Problem_Codes_FDA_CDRH C50857 1847 Fainting Extremely weak; threatened with syncope. C50635 2418 Loss of consciousness FDA C54450 Patient_Problem_Codes_FDA_CDRH C50859 1824 Edema, Stromal Stromal edema Fluid from the aqueous humor enters the corneal stroma and causes swelling. Fluid from the aqueous humor enters the corneal stroma and causes swelling. C50508 1791 Corneal Edema FDA C54450 Patient_Problem_Codes_FDA_CDRH C50861 1716 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. 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. C50797 2335 Regurgitation, Valvular FDA C54450 Patient_Problem_Codes_FDA_CDRH C50862 1510 Radiation Overdose Overdose of radiation C50873 1988 Overdose FDA C54450 Patient_Problem_Codes_FDA_CDRH C50863 1154 Wound Dehiscence Dehiscence wound C50527 2502 Dehiscence of organ FDA C54450 Patient_Problem_Codes_FDA_CDRH C50868 2497 Suture Abrasion C50449 1689 Abrasion FDA C54450 Patient_Problem_Codes_FDA_CDRH C50870 2545 Autotransfusion Reinfusion of blood or blood products derived from the patient's own circulation. Infusion of previously obtained autologous blood or blood products back to the same individual. C15192 2337 Transfusion Of Blood Products FDA C54450 Patient_Problem_Codes_FDA_CDRH C50873 1988 Overdose C36291 Finding by Cause FDA C54450 Patient_Problem_Codes_FDA_CDRH C50888 1963 Mitral Insufficiency Insufficiency, mitral Dysfunction of the mitral valve, with incomplete valve closure resulting in valvular regurgitation. C50796 1926 Insufficiency, Valvular FDA C54450 Patient_Problem_Codes_FDA_CDRH C50896 1892 Hemorrhage, Intraventricular Intraventricular hemorrhage C50485 1889 Hemorrhage, cerebral FDA C54450 Patient_Problem_Codes_FDA_CDRH C50901 1823 Edema, Microcystic Microcystic edema Corneal edema of inflammatory origin associated with contact lens wear and morphologically characterized by presence of epithelial microcysts. Microcysts are small (typically 10-50 microns in diameter), clear, irregularly shaped high refractive inclusions that form in the basal layers of the epithelium and move towards the anterior surface of the cornea, surrounding epithelial haze. The cause of microcytic edema is related to the physical presence of contact lenses and possibly a mechanical effect of lens wear. C50508 1791 Corneal Edema FDA C54450 Patient_Problem_Codes_FDA_CDRH C50909 2671 Limited Mobility Of The Implanted Joint C50603 1924 Implant, Failure Of FDA C54450 Patient_Problem_Codes_FDA_CDRH C50910 2651 Osteopenia Bone Loss Decreased calcification or density of bone tissue. C27572 Non-Neoplastic Bone Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C50911 2510 Sudden Cardiac Death Cardiac death, sudden|Death, sudden cardiac An unexpected natural death from a cardiac cause within a short time period, generally less than 1 hour from the onset of symptoms, in a person without any prior condition that would appear fatal. SCD is most likely to occur in a patient with an underlying cardiac abnormality, whether known or not; approximately 70% of SCDs are caused by coronary heart disease. A loss of heart function is often attributed to a cardiac arrhythmia, but classifications based on clinical circumstances cannot be considered definitive. C54196 Cardiac Death FDA C54450 Patient_Problem_Codes_FDA_CDRH C50912 2645 No Patient Involvement C27993 General Qualifier FDA C54450 Patient_Problem_Codes_FDA_CDRH C50914 2646 Inadequate Osteointegration C36288 Connective and Soft Tissue Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C50915 2647 Nerve Proximity NOS (Not Otherwise Specified) C20189 Property or Attribute FDA C54450 Patient_Problem_Codes_FDA_CDRH C50916 2273 Teratogenic Effects Effects, teratogenic C16956 Pathologic Process FDA C54450 Patient_Problem_Codes_FDA_CDRH C50917 2465 Labor, Premature Premature labor 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. 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. C21173 Reproductive Process FDA C54450 Patient_Problem_Codes_FDA_CDRH C50920 2110 Transplant Of Organ/Tissue Organ/tissue transplant|Tissue/organ transplant C19697 Tissue Sample FDA C54450 Patient_Problem_Codes_FDA_CDRH C50921 2058 Staphylococcus Aureus S. aureus A common bacterial species found especially on nasal mucous membrane and skin (hair follicles); bacterial species that produces exotoxins including those that cause toxic shock syndrome, with resulting skin rash, and renal, hepatic, and central nervous system disease, and an enterotoxin associated with food poisoning; it causes furunculosis, cellulitis, pyemia, pneumonia, osteomyelitis, endocarditis, suppuration of wounds, other infections; also a cause of infection in burn patients; humans are the chief reservoir. C62585 Coagulase-Positive Staphylococcus FDA C54450 Patient_Problem_Codes_FDA_CDRH C50922 2499 Infective Agents Agents, infective C14376 Other Organism Groupings FDA C54450 Patient_Problem_Codes_FDA_CDRH C50923 1805 Decreased Apgar C50416 1718 Apgar Score, Decreased Or Low FDA C54450 Patient_Problem_Codes_FDA_CDRH C51220 1707 Anesthesia, insufficient, light or patchy Patchy, light or insufficient anesthesia|Light, patchy or insufficient anesthesia|Insufficient, light or patchy anesthesia C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C51221 1710 Angina A heart condition marked by paroxysms of chest pain due to reduced oxygen to the heart. C37254 Cardiovascular System Signs and Symptoms FDA C54450 Patient_Problem_Codes_FDA_CDRH C51222 1713 Antibiotics, reaction to C25637 2414 Reaction FDA C54450 Patient_Problem_Codes_FDA_CDRH C51223 1715 Aortic insufficiency Dysfunction of the aortic valve, with incomplete valve closure resulting in valvular regurgitation. C50796 1926 Insufficiency, Valvular FDA C54450 Patient_Problem_Codes_FDA_CDRH C51224 1730 Atrial Flutter C35061 Supraventricular Tachycardia FDA C54450 Patient_Problem_Codes_FDA_CDRH C51225 1736 Biliary Cirrhosis Cirrhosis, biliary C2951 Cirrhosis FDA C54450 Patient_Problem_Codes_FDA_CDRH C51447 2022 Pulmonary Insufficiency Insufficiency, pulmonary C27557 Non-Neoplastic Lung Disorder FDA C54450 Patient_Problem_Codes_FDA_CDRH C52352 2152 Great Vessel Perforation Perforation, great vessel C50804 2135 Vessels, Perforation Of FDA C54450 Patient_Problem_Codes_FDA_CDRH C52354 2166 Radiation Underdose Underdose, radiation C50428 2542 Underdose FDA C54450 Patient_Problem_Codes_FDA_CDRH C54027 Medical Problem Patient Problem Code|Patient Problem C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C54685 1695 Adhesion(s) C36288 Connective and Soft Tissue Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C61375 2681 Tissue Breakdown A process caused by injury or disease or aging and characterized by a partial/complete disruption of tissue. The disruption may be temporary or permanent and may be associated with either (1) impairment or (2) loss of function of the affected organ(s) or system(s). C50773 2104 Tissue Damage FDA C54450 Patient_Problem_Codes_FDA_CDRH C61389 2424 Patch test, abnormal results of C35682 Positive Test Result FDA C54450 Patient_Problem_Codes_FDA_CDRH C61390 1348 Lead(s), burn(s) from C34441 1757 Burn(s) FDA C54450 Patient_Problem_Codes_FDA_CDRH C61392 1351 Lead(s), shock from C35016 2072 Shock FDA C54450 Patient_Problem_Codes_FDA_CDRH C61395 1507 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. An electrocardiographic finding phenomena in which the R wave occurs on top of the T wave; this can trigger ventricular fibrillation or ventricular tachycardia. C41328 Electrocardiographic Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C61401 1509 Radiation Exposure, Unintended C61398 Radiation Exposure FDA C54450 Patient_Problem_Codes_FDA_CDRH C61409 1186 Dissection C36295 Other Finding FDA C54450 Patient_Problem_Codes_FDA_CDRH C72898 Zonular Dehisence C50527 2502 Dehiscence of organ FDA C54450 Patient_Problem_Codes_FDA_CDRH C73501 Perinatal Brain Injury Injury occurring as a result of the delivery process. Injury occurring as a result of the delivery process. C50440 2219 Brain Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C73502 Cardiac perforation C45430 Heart Injury FDA C54450 Patient_Problem_Codes_FDA_CDRH C73503 2065 Increased sensitivity Sensitivity C25637 2414 Reaction FDA C54450 Patient_Problem_Codes_FDA_CDRH C73504 Decreased sensitivity C25637 2414 Reaction