Source NCIt Subset Code FDA Subset Name NCIt Concept Code FDA Source Code FDA Source PT FDA Source Synonym(s) FDA Source Definition NCIt Definition Parent Concept's NCIt Concept Code Parent Concept's FDA Source Code Parent Concept's FDA Source PT FDA C62596 FDA Center For Devices and Radiological Health Terminology C37930 3274 CONSTIPATION Irregular and infrequent or difficult evacuation of the bowels. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C62596 FDA Center For Devices and Radiological Health Terminology C19238 DIAGNOSTIC, THERAPEUTIC, OR RESEARCH EQUIPMENT A manufactured object that is used to perform diagnostic, therapeutic or research activities. C62596 FDA C62596 FDA Center For Devices and Radiological Health Terminology C99179 3273 NOISE, AUDIBLE ACOUSTIC NOISE|AUDIBLE NOISE|NOISE, ACOUSTIC An unintended or unpleasant sound that emanates from a device. C62961 1384 MECHANICAL ISSUE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50372 3028 ABSORBER A device or material designed to take in or attenuate a force or substance. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49804 401 ABSORBER (CO2) A device or material designed to sequester cardon dioxide. C50372 3028 ABSORBER FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49806 548 ACCUMULATOR A device or material designed to collect a force or substance. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49807 402 ACTUATOR A device designed to automate an action. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49808 431 ADAPTER (ADAPTOR) A device designed to make different pieces of apparatus compatible. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C89528 3194 ADHESIVE Any substance that affixes 2 or more parts or tissues together. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49810 552 AIR CLEANER A filtering device designed to remove particles from air. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50339 3029 AIR ELIMINATOR A device designed to remove air from a space or fluid. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49811 549 AIR PUMP ASSEMBLY A composite part of an air pump or a larger device that includes an air pump. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49813 403 ALARM A device designed to signal the occurrence of a particular event. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49812 404 ALARM, ASSEMBLY A composite part of an alarm or a larger device that includes an alarm. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49814 405 ALARM, AUDIBLE A device designed to signal the occurrence of a particular event by making a sound. C49813 403 ALARM FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49817 407 ALARM, HIGH INSPIRATORY PRESSURE A device designed to signal the occurrence of a high pressure event associated with a mechanical ventilation device. C49816 412 ALARM, PRESSURE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49815 408 ALARM, LED A device designed to signal the occurrence of a particular event by activating a light emitting diode. C49813 403 ALARM FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49819 409 ALARM, LOW INSPIRATORY PRESSURE A device designed to signal the occurrence of a low pressure event associated with a mechanical ventilation device. C49816 412 ALARM, PRESSURE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49818 410 ALARM, OXYGEN PRESSURE A device designed to signal that an oxygen source pressure is outside of an established range. C49816 412 ALARM, PRESSURE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49820 411 ALARM, POWER A device designed to signal the occurrence of a power fluctuation beyond an established range. C49813 403 ALARM FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49816 412 ALARM, PRESSURE A device designed to signal the occurrence of a pressure fluctuation beyond an established range. C49813 403 ALARM FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49821 550 ALARM, SELF C49813 403 ALARM FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49822 413 ALARM, VISUAL A device designed to signal the occurrence of a particular event in a way that can be seen. C49813 403 ALARM FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49823 414 ALARM, VOLUME A device designed to signal that a gas volume level is outside of an established range. C49813 403 ALARM FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49824 590 ALTERNATOR An electric generator designed to produce an alternating current. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50057 591 ALTIMETER A device designed to measure height above the ground. C50052 462 GAUGES/METERS FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49825 592 AMPLIFIER An electronic device designed to take an input signal and output an increased signal strength. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49826 593 ANALYZER Any device designed to perform an analysis. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49827 594 ANNUNCIATOR A device designed to indicate which electrical circuit is actively receiving current. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49828 595 ANTENNA A device designed to transmit or receive electromagnetic signals. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50341 3030 APPLICATOR A device designed to transfer a substance to a surface. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49829 596 ARRESTER A device designed to prevent a certain action, such as one that protects an electical system from voltage or current surges. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49830 597 ATTENUATOR An electrical device designed to reduce the strength of a signal. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50317 3031 AUTOMATIC INJECTION SYSTEM A system designed to pump a gas or liquid into a space or environment without outside intervention. C50316 3076 INJECTION SYSTEM FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49831 598 BACKPANEL A rigid, removable sheet that covers the back of a device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49832 599 BACKPLANE A circuit board with connectors into which other cards are plugged. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49958 417 BACTERIAL FILTER A filter designed to remove bacteria from a gas or liquid. C49956 816 FILTER FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49833 730 BAFFLE A plate or similar structure designed to direct the flow of a fluid or dissipate its energy. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49834 553 BAGS A flexible container, often with a single opening. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49835 418 BALL Any device that is spherical in shape. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49836 731 BALLAST An electrical device designed to limit an electric current or to provide a starting voltage. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49837 419 BALLOON Any of various types of bags designed to be distended. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49838 732 BARRIER A structure or object that impedes free movement. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49839 420 BATTERY A device designed to produce an electric current through chemical reaction. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50346 3032 BATTERY CHARGER A device designed to restore the capacity of a battery. C49868 426 CHARGER FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49841 733 BEAM SPLITTER An optical device designed to take an electromagnetic beam and separate it into two or more parts. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49842 734 BEARINGS A point of contact between moving parts designed for support or to reduce friction. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C51066 3033 BED, ASSIST BAR Handle-like devices designed to facilitate a person's ability to get upright and out of a bed. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49843 735 BELL A device designed to make a ringing sound when struck. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49844 737 BELT A device consisting of a narrow loop of material moving over shafts or pulleys. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49845 738 BLOWER A device designed to produce a stream of air. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49846 739 BOBBIN A device around which thread, tape, or other flexible material can be wound. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50056 740 BOLOMETER A device designed to measure heat radiation. C50052 462 GAUGES/METERS FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49847 741 BOLT A screw designed to thread into a nut to form a fastener. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50289 3034 BOLUS MECHANISM A device designed to deliver a bolus into a system. C50285 3085 MECHANISM FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49848 554 BOTTOM DEAD CENTER SENSOR BRACKET A bracket designed for holding a bottom dead center sensor. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49849 742 BRAKE A device designed to slow or stop a moving part. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49850 422 BREATHING CIRCUIT In an anesthesia machine, the pathway by which a gaseous anesthetic agent and oxygen are delivered to the patient and carbon dioxide is removed. The circuit can be open or closed. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49851 743 BRUSH Device consisting of hairs or bristles set into a handle or holder, especially one that conducts current between the rotating and stationary parts of a generator or motor. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50354 3035 BUBBLE DETECTOR A device designed to signal the presence of bubbles in a system. C49916 787 DETECTOR FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49852 745 BUS A set of electrical conductors designed to route data from multiple locations in a computer. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49853 746 BUSHING A cylindrical metal sleeve designed to reduce the friction of a rotating shaft. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49854 736 BUZZER An electronic signaling device designed to make a buzzing sound by vibration of an armature. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49855 423 CABLE A long, thin, multistranded rope or rope-like object; a multistranded conductor designed to carry signals over a distance. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49857 747 CALIBRATOR An instrument designed to measure the size of an opening or one used to increase the diameter of an opening; can also refer to a standard or reference material used to set the operating parameters of an instrument. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA 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 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50343 3036 CANNULA A small flexible tube inserted into a body cavity for draining off fluid or introducing medication. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50274 3037 CANNULA GUIDE A device designed to assist in the proper placement of a cannula. C49974 829 GUIDE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49859 749 CANNULA, INNER The inner component of a double-cannula device, designed to be easily removable and replaceable. C50343 3036 CANNULA FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49860 750 CANNULA, OUTER The outer component of a double-cannula device, designed to be indwelling. C50343 3036 CANNULA FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49861 424 CAP A top (as for a bottle). C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49862 555 CAPACITOR An electrical device designed to store an electric charge. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49863 752 CARRIER A device designed to facilitate the support, movement, or transport of another device or object. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49864 556 CASCADE A collection of interconneced devices designed to act together to repeat and enhance a signal. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49865 425 CASSETTE A container designed to hold film or magnetic tape. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49866 753 CASTER A pivoting roller or wheel designed to attach to an object to make it movable. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50344 3038 CATHETER A flexible tube designed to transfer fluids into or out of the body. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50345 3039 CAUTERY A device designed to coagulate and seal blood vessels or to destroy tissue with heat or electric current. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49867 754 CELL A device that is designed as a removable and replaceable part of another device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49868 426 CHARGER A device designed to restore the capacity of a system. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49869 755 CHASSIS A supporting frame designed to hold other components or devices such as the chassis of a car or the internal frame of an electronic device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49870 756 CHOKE A valve designed to control the flow of air to a carburetor or a coil in an electronic circuit that passes direct current and attenuates alternating current. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49871 427 CIRCUIT BOARD A non-conducting board to which electronic components are attached. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50347 3040 CIRCUIT BREAKER A device designed to open an electrical circuit when it becomes overloaded. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49872 757 CLAMP A device designed to hold things firmly together. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49873 758 CLIP A small device designed to hold and attach items together. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49874 759 CLOCK A device designed to indicate the time of day or to measure the time duration of an event or action. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C53997 428 CO2 MONITOR A device designed to sense the level of or warn of carbon dioxide in a space or environment. C50074 886 MONITOR FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49875 429 CO2 MONITOR SUBASSEMBLY (ONLY USE WHEN PART OF ANOTHER DEVICE) A carbon dioxide monitor assembly designed to be part of another device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49876 760 CODER A device designed to generate a code. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49877 761 COIL A structure consisting of something wound in a continuous series of loops. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49881 762 COLLIMATOR A diaphragm or system of diaphragms made of an absorbing material, designed to define and restrict the dimensions and direction of a beam of radiation. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49882 763 COMPARATOR A device for comparing something with a similar thing or with a standard measure. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50129 557 COMPRESSOR (AIR PUMP) A pump designed to facilitate the movement or compression of air. C50128 925 PUMP FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C61402 3041 COMPUTER HARDWARE The physical components from which a computer is constructed (electronic circuits and input/output devices). C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C61403 3042 CONCENTRATE A reduced-volume form of the liquid that is used in a dialysis machine to carry away waste products. C76185 3050 DEVICE INGREDIENT OR REAGENT FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49883 558 CONCENTRATOR A device designed to increase the weight per unit volume of a substance, or in communications, a device that combines data streams in a way that they can be separated after transmission. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49878 559 CONDUCTOR COIL A coil consisting of a conducting material such as that in a solenoid. C49877 761 COIL FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49884 560 CONNECTING ROD A rod designed to transmit motion between moving parts. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49885 435 CONNECTOR Any device or coupling designed to serve as a link between devices. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50295 3043 CONNECTOR PIN A projecting part of a device that allows it to be secured through an opening. C50101 906 PIN FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50031 764 CONTACT LENS A corrective, cosmetic, or therapeutic lens placed on the cornea of the eye. C50030 866 LENSES FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50204 436 CONTROL SWITCHES A switch designed to control or regulate the operation of a device. C50199 519 SWITCHES FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49887 765 CONTROLLER A device designed to control or regulate the operation of another device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49888 766 CONVERTER A device designed to change a substance, form, or state into another. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50319 3044 COOLING MODULE COOLING SYSTEM A device designed to regulate and lower the temperature of a heat generating device or system. C50311 3116 SYSTEM FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49890 768 CORD A flexible cable designed to connect electronic devices. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49893 769 CORE A rod that sits within a coil, or a general term refering to the central, main part of a device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49894 770 COUNTER A device designed to keep track of the number of times something happens. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50352 3045 COUNTERBALANCE A weight designed to counteract the effects of another weight. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49895 771 COUPLER Any device designed to connect other objects. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49896 772 COVER An object designed to conceal, enclose, cap, or protect something. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50332 3046 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 3041 COMPUTER HARDWARE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49897 437 CPU (CENTRAL PROCESSING UNIT) BOARD The main circuit board housing the central processing unit. C61402 3041 COMPUTER HARDWARE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49898 561 CRANK ARM ASSEMBLY An extension to a shaft designed to impart a rotational energy to the shaft. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50238 438 CRT (CATHODE RAY TUBE) An evacuated glass tube designed to accelerate electrons onto a screen to create images. C50236 525 TUBE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49899 773 CRYSTAL A clear cover over an instrument or any crystalline element component of an electronic device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49900 562 CUFF A bandlike device or structure that encircles a body part or another device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50165 563 CUP SEAL A circular seal with a depressed center and raised sealing lips. They are designed to contain high pressure in one direction but not the other. C50163 432 SEAL FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49901 774 CUPS Any part of a device that resembles a bowl-shaped container. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49902 775 CURRENT LIMITER A device designed to maintain a current at a specified level regardless of other fluctuations in the system. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49903 776 CURRENT SOURCE An electronic device designed to generate a constant current. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49904 439 CUSP A device consisting of flexible biocompatible membranes, implantable in the cardio-vascular system, designed to prevent retrograde flow of blood but not impede a forward flow. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49905 777 CUTTER A device designed to slice or sever a material. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50342 3047 CUTTER-TORQUE CABLE A cable designed to drive the rotational cutter of a catheter device. C49855 423 CABLE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49906 440 CYLINDER Any part of a device that resembles an enclosed tube; a cylindrical container for the storage of gases and fluids. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50259 441 CYLINDER VALVE A valve designed to regulate the flow from a storage cylinder. C50243 527 VALVE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49907 778 DAMPER A device designed to reduce the flow of air through a duct or an electronic device designed to decrease the amplitude of oscillations in a sytem. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50241 779 DATA ACQUISITION UNIT A device designed to automatically receive and store data and format it for later use. C50329 3127 UNIT FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49908 780 DECODER A device designed to convert a coded signal or message to an uncoded version. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49909 442 DEFIBRILLATOR PADDLES The part of a defibrillator designed to be placed in contact with the body. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49910 443 DEFIBRILLATOR SUBASSEMBLY (ONLY USE WHEN PART OF ANOTHER DEVICE) An electronic device designed to deliver a controlled electric shock to the heart in order to restore a normal heart rhythm, as a part of a larger device. C53996 3051 DEVICE SUBASSEMBLY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49911 781 DEHUMIDIFIER A device designed to remove moisture from the air. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49912 782 DEHYDRATOR A device designed to remove moisture from a substance or material. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50353 3048 DEIONIZER A device designed to remove ions from a substance or environment. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49913 783 DELAY LINE A communication or electronic circuit designed to delay the transmission of a signal by a set amount. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49914 784 DEMAGNETIZER A device designed to remove the magnetic properties of an object or material. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49915 785 DEMODULATOR A device designed to isolate a data signal from a carrier wave. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50055 786 DENSITOMETER A device designed to measure density. C50052 462 GAUGES/METERS FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49916 787 DETECTOR A device designed to signal the presence of a specific condition. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49755 3049 DEVICE COMPONENT OR ACCESSORY A physical object that is a medical device or a component or accessory of a medical device. C19238 DIAGNOSTIC, THERAPEUTIC, OR RESEARCH EQUIPMENT FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49918 788 DEVICE DEPLOYER A device designed to install something or distribute something in a systematic way. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C76185 3050 DEVICE INGREDIENT OR REAGENT A consumable material that is added to a device and is used to make a finished product or becomes part of a finished product. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C53996 3051 DEVICE SUBASSEMBLY A largely self-contained device designed to be incorporated into a larger device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49919 789 DIAL Either a circular indicator or a control knob on a device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49920 445 DIAPHRAGM A device consisting of a flexible sheet or partition. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49921 790 DIGITIZER A device designed to convert analog signal to digital signal. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49922 447 DIODE An electronic component designed to pass current in one direction only. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49924 448 DISCRETE COMPONENT/DEVICE (RESISTOR, CAPACITOR, DIODE) A device that exists separate from other devices; can refer to electronic components that are not part of an integrated circuit. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49925 791 DISK Any device component shaped like a disk, especially those used for data storage. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49927 416 DISPLAY A device designed to present information visually. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49928 792 DIVIDER C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49929 793 DOME A device component designed with a hemispherical shape. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49930 794 DOUBLER An amplifier that doubles the voltage or frequency of an input signal. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49931 795 DRIVER A computer interface designed to control the interaction between a CPU and a peripheral device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49932 796 DUCT A device structure designed to channel the movement of gas or liquid. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49933 797 DUMMY LOAD A simple electronic device used for testing purposes designed to draw the same current as a complex device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49934 798 DUPLEXER An electronic switching device that allows an antenna to be used for both transmitting and receiving. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50075 450 EKG/ECG MONITOR A device designed to give a continuous reading of the electrical currents of the heart. C50074 886 MONITOR FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49935 449 EKG/ECG SUBASSEMBLY (ONLY USE WHEN PART OF ANOTHER DEVICE) An electronic device designed to record the electric currents of a beating heart, as part of a larger device. C53996 3051 DEVICE SUBASSEMBLY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50027 452 ELECTRICAL LEAD C50282 3079 LEAD FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50336 3052 ELECTRICAL WIRE A wire designed for electrical transmission of signal or power. C50269 430 WIRE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49936 451 ELECTRODE A conductor that is designed to make contact with part of a circuit or system. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50351 3053 ELECTRODE CONTACT A connector on a device designed to couple with an electrode. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50308 3054 EMERGENCY STOP BUTTON OR SWITCH A button and circuits designed to force the shutdown of a machine or device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50309 3055 EMERGENCY TABLE STOP A mechanism designed to quickly halt the movement of a feed table. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49937 799 EMITTER The electron source electrode in a transistor or any source in a system. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49938 800 ENCLOSURE A structure designed to house a device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49939 801 ENCODER A device designed to covert a signal or message to a coded version. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49940 802 ENDOSCOPE A device consisting of a tube containing flexible optic fibers that may be inserted into a body opening to allow a doctor to examine hollow organs inside the body. The result may be viewed on a video screen. It has diagnostic (e.g., biopsy) and therapeutic capabilities. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50338 3056 ENDOSCOPIC ACCESSORY A supplementary device or component designed to work with an endoscope. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50049 454 EPROM (ERASABLE PROGRAMMABLE READ ONLY MEMORY) A type of read only memory device that can be written to after manufacture, erased, and reused. C50050 503 PROM (PROGRAMMABLE READ ONLY MEMORY) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49941 803 EQUALIZER An electronic device designed to alter the frequency of a signal, usually to adjust for distortion. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49942 804 EVAPORATOR A device designed either to drive a volatile solvent from a material or to cause vaporization within a heating/cooling system. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49957 455 EXHALATION FILTER A filter designed to remove something from the expiration stream of a ventilator. C49956 816 FILTER FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49943 805 EXPANDER A device designed to stretch or enlarge a structure. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49944 806 EXTENDER A device designed to lengthen a structure. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50359 3057 EXTERNAL FIBEROPTIC A fiberoptic device designed to remain outside of the body. C50358 3059 FIBEROPTIC FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49945 807 EXTRACTOR A device designed to remove or separate a material or object from some other material or object. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49946 808 EYELET A device designed to create a hole in an object for the passage of a cord. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50208 456 FAIL-SAFE SYSTEM A device designed to prevent malfunction, unsafe, or unauthorized operation of a device or system. C50311 3116 SYSTEM FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49947 809 FAN A device designed to create an air current through the rotation of a planar surface. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49948 810 FASTENER A device designed to hold something in place. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49949 811 FEEDTHRU A device designed to allow a connection to pass through a structural component of a device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49950 812 FERRULE A metal cap designed to strengthen the end of an implement. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49951 813 FET (FIELD EFFECT TRANSISTOR) A transistor designed so that current through it is controlled by a variable electric field. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49952 814 FIBER Any device made from a long, slender material. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50362 3058 FIBERGUIDE A device designed to assist in installation of fiberoptic cables. C49974 829 GUIDE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50358 3059 FIBEROPTIC A device made with thin glass fibers as a conduit for transmission of light. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50348 3060 FIBEROPTIC CLADDING A material designed to form an outer protective surface on an optical fiber. C50358 3059 FIBEROPTIC FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50349 3061 FIBEROPTIC CLEAVER A device designed for cutting an optical fiber and processing the ends for attachment. C50358 3059 FIBEROPTIC FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49955 815 FILM A photographic material designed to capture an image upon exposure to electromagnetic radiation. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C76119 3062 FILM CARTRIDGE A device to hold an amout of film and facilitate its loading into a device. C49955 815 FILM FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C69444 3063 FILM PROCESSOR A device designed to chemically treat film to develop the images on it. C50122 919 PROCESSOR FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49956 816 FILTER A device designed to remove something from whatever passes through it. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49959 457 FLANGE A protruding edge designed to strengthen or stabilize a device or facilitate its attachment to a surface. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49960 817 FLASHER An electric device designed to repeatedly and rapidly turn a light on and off. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50054 458 FLOWMETER A device designed to measure the flow rate of a fluid. C50052 462 GAUGES/METERS FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49961 818 FOIL A thin, flexible sheet of metal. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49962 819 FOOT PEDAL A lever designed to be operated with the foot. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50202 459 FOOT SWITCH A switch designed to be actuated by foot pressure. C50199 519 SWITCHES FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49963 820 FRAME A structure designed to support or contain an object. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50002 460 FUNCTION INDICATOR A device designed to monitor a specific function of a system. C50001 844 INDICATOR FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50284 3064 FUNCTION INDICATOR LIGHT A lighted component that is part of a function indicator. C50002 460 FUNCTION INDICATOR FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49964 564 FUNCTION LID C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49965 821 FURNACE An enclosed chamber designed to produce heat. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49966 822 FUSE An electrical device designed to stop the flow of current when an overload condition exists. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50314 3065 GAS DELIVERY SYSTEM A system designed to supply a gas flow to another device or system. C50311 3116 SYSTEM FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49967 461 GAS SCAVENGING A device designed to remove certain gases from a gas stream or environment. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49968 823 GASKET A preformed material designed to form a seal between connecting surfaces. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50052 462 GAUGES/METERS METER A device designed to give a visual indication of the condition of a system. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49969 565 GEARS GEAR A toothed wheel designed to mesh with another toothed object and transmit motion. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49970 825 GENERATOR An engine designed to produce electricity or a device designed to produce a vapor or gas. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49971 826 GRILLE A framework of bars designed as a covering or divider. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49972 827 GROMMET A ring-like device designed for lining a round opening for reinforcement or protection. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49973 828 GROUND STRAP A wire cable or strap designed to carry current safely away from an electronic device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49974 829 GUIDE A device designed to help direct the passage of another object. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50271 463 GUIDEWIRE A flexible wire designed to help position medical devices within the body. C50269 430 WIRE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50281 3066 HAND IMMOBILIZER A device designed to limit the movement of the hand such as a splint for therapy or a restraint for phlebotomy. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50275 3067 HANDPIECE A part of a mechanical device designed to be used while held in the hand. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50276 3068 HANDREST A part of a device designed to stabilize or support the hand. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49977 830 HANDSET The part of a telephone that has the earpiece and mouthpiece and is designed to be held in the hand. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50277 3069 HAPTIC A device designed to give physical feedback in a remote control system. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49978 464 HEADER A pipe containing multiple feeder pipes, especially the exhaust pipe that connects to each cylinder of an engine. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49979 831 HEADPHONE A device with sound speakers designed to be worn on the head in proximity to the ears. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49980 832 HEADS A projection on the end of an object C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49982 833 HEADSET An accessory for a telephone that is worn on the head and designed to allow handsfree conversation. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49983 465 HEART VALVE CAGE The part of a mechanical heart valve designed to contain and guide the occluder ball in a cage and ball valve. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50029 466 HEART VALVE LEAFLET A mechanical heart valve where the valve mechanisms consists of two thin blades that hinge from the center and regulate the flow of blood. C50283 3081 LEAFLET FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50150 834 HEART VALVE SEWING RING A ring of supportive material around a heart valve designed to provide a stable surface for attachment to surrounding tissues. C50148 943 RING FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49984 835 HEAT EXCHANGER A device designed to transfer heat between fluids across a barrier or to the environment. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49985 836 HEAT SINK A thermally conductive structure designed to carry heat away from an electronic device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49986 467 HEATER A device designed to generate heat. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49987 566 HEATER ROD The rod-like part of certain heaters from which the radiant energy is released. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49880 567 HELIFIX COIL A coil designed to allow a Helifix pacing electrode to be placed in the endocardium. C49877 761 COIL FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50335 3070 HEMO VALVE A device component of a catheter assembly designed to prevent backflow of blood and thus minimize inadvertent blood loss while accessing the vasculature. C50243 527 VALVE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50302 3071 HERMETIC SEAL A seal designed to be airtight. C50163 432 SEAL FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49988 837 HINGE A device designed to join two objects and allow them to swing relative to one another. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49989 838 HOLDER A device designed to hold another object. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49953 468 HOLLOW FIBER Any device made from a fiber with a hollow center, particularly those for cell propagation in culture. C49952 814 FIBER FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50279 3072 HOSE A flexible tube designed to carry a fluid. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50280 3073 HOSE LINE A flexible tube designed to carry a fluid. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49990 839 HOUSING A structural enclosure designed to contain or support a device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49991 469 HUB An electronic device designed as a central connection for other devices. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49992 470 HUMIDIFIER A device designed to add moisture to the air. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49993 471 HYBRID CIRCUIT An electronic device containing circuits of different technological types. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50313 3074 HYDRAULIC BED SYSTEM A bed that includes a hydraulic system designed for movement or positioning of an object or subject. C50311 3116 SYSTEM FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50312 3075 HYDRAULIC SYSTEM A system designed to use fluid pressure to bring about movement. C50311 3116 SYSTEM FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49994 474 IC (INTEGRATED CIRCUIT) A device that uses only integrated circuits. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49995 472 IC (INTEGRATED CIRCUIT) CHIP A microelectronic device that incorporates many interconnected transistors and components. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49996 840 IGNITER A device designed to light a fire. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49997 841 IMAGER A device designed to create or record a visual representation of something. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49998 842 IMPEDANCE CONVERTER A device designed to change the restistance of an electric circuit. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50000 843 INDEXER A device designed to create an electronic index of information. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50001 844 INDICATOR A device designed to show an operating condition of a system or to attract attention. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50003 845 INDUCTOR A device designed to introduce electromotive force to a circuit, usually a coil surrounding a wire. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50316 3076 INJECTION SYSTEM INJECTOR SYSTEM A system designed to pump a gas or liquid into a space or environment. C50311 3116 SYSTEM FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50004 473 INSULATION A material designed to reduce the transmission of heat, sound, or electricity. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50005 846 INTEGRATOR C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50006 847 INTERCOM A communications device designed for use between rooms of a building. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50007 569 INTERCONNECTION BOARD INTUBATE C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA 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 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50009 849 INTERRUPTER A device designed to stop the flow of current in a circuit. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50298 3077 INTRAVENOUS POLE A structural device designed to hang an intravenous solution bag. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50010 850 INVERTER An electrical device that converts direct current to alternating current. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49999 851 IOL (INTRAOCULAR LENS) IMPLANT A corrective lens that is designed to be implanted within the eye capsule to replace the natural lens. C50030 866 LENSES FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50011 852 ISOLATOR Any material or structure designed to limit the interaction between two components. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50012 853 JACK A tool designed to lift an object. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C54020 1028 JAW A device designed to use opposing parts to close on and hold an object. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50013 854 JOINT A device designed as the junction between objects; it may be flexible or rigid. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50015 855 JOYSTICK A control device that uses a movable handle to create two-axis input for a computer device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50016 856 JUMPER A small connector designed to make temporary connections in electrical circuits. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50017 857 JUNCTION A device designed to join two or more things. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50018 475 KEYBOARD A device consisting of mechanical keys that are pressed to create input to a computer. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50019 858 KEYER A device designed for signaling by hand using one or more switches. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50020 859 KEYPAD A device consisting of keys, usually in a block arrangement, that provides limited input to a system. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50021 860 KIT A collection of objects or devices collected together for a particular function or purpose. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C54021 3156 KNIFE A cutting device usually consisting of a sharpened blade attached to a handle. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50022 861 KNOB A handle, usually attached to a shaft allowing manual rotation of the shaft. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50023 862 LABEL Any written, printed, or graphic matter upon a device to identify its nature, ownership, or other characteristic particulars of the device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50024 863 LAMINATE A material consisting of multiple layers bonded together. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50025 864 LAMP A device designed to produce light or heat. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50026 865 LASER A device designed to emit a monochromatic beam of coherent light. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50292 3078 LASER NOZZLE A device through which a laser beam emerges. C50291 3092 NOZZLE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C54022 1030 LATCH A fastening device for a swinging part usually consisting of a bar that is retained in a slot. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50282 3079 LEAD An insulated electrical conductor designed to connect to an electrical device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50028 476 LEAD CONDUCTOR A bundle of leads designed to connect between a pacing device and implanted heart electrodes. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50326 3080 LEAD TIP A device designed to form the end of an electrical lead. C50324 3123 TIP FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50283 3081 LEAFLET Any device that resembles a small leaf, especially one that has two thin blades hinged in the center. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50357 3082 LEAFLET DISK A disk-shaped valve component of a tilting disk mechanical heart valve. C50283 3081 LEAFLET FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49923 477 LED (LIGHT EMITTING DIODE) A type of diode designed to emit light when a current passes through it. C49922 447 DIODE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50030 866 LENSES An electric or optical device designed to focus electromagnetic radiation. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50201 478 LIMIT SWITCH A switch designed to cut off power automatically to a moving object when it reaches a predetermined point. C50199 519 SWITCHES FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50032 867 LIMITER An electronic device designed to prevent the amplitude of a wave from exceeding a set limit. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50033 868 LINE CONDITIONER An electronic device designed to improve the output quality of a power source, typically by smoothing the output voltage. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49840 479 LITHIUM IODIDE BATTERY A battery consisting of a lithium anode and a cathode of iodine and poly-2-vinyl pyridine. They are especially useful in devices like pacemakers because of their long life. C49839 420 BATTERY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50034 869 LOAD Any device that draws current from an electrical system. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50035 870 LOCK A fastening device designed to hold, close, or secure. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50286 3083 LOCKING MECHANISM A fastening device designed to hold, close, or secure. C50285 3085 MECHANISM FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50036 571 LOCKING SLEEVE A cylindrical fitting that slides over a part and locks into place. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50287 3084 LOCKOUT MECHANISM A device designed to prevent multiple, simultaneous connections to a system. C50285 3085 MECHANISM FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50037 480 LOGIC BOARD The circuit board that contains most of the processor units. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50038 572 LOWER PISTON BEARING A bearing located toward the bottom of a piston. C49842 734 BEARINGS FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50260 481 LUER VALVE A valve that incorporates a Luer fitting. C50243 527 VALVE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50039 871 MAGAZINE A compartment in a device designed to house a consumable material for feeding into a mechanism. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50040 482 MAGNET A device that attracts iron and produces a magnetic field. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50041 872 MAGNETIZER A device designed to make another object magnetic. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50053 873 MAGNETOMETER A device designed to measure the strength of a magnetic field. C50052 462 GAUGES/METERS FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50042 874 MAGNETORESISTOR A variable resistor that can be controlled by a magnetic field. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50043 875 MAGNIFIER An optical device designed to enlarge an image. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50044 483 MANIFOLD A branched system of pipes, typically those that attach to an engine to carry away exhaust. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50045 876 MATRICES C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50285 3085 MECHANISM A device consisting of moving parts designed to perform a function. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50046 484 MEMBRANE A device that is made from or resembles a thin flexible sheet of material. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50047 877 MEMORY Any device that can hold data in machine-readable format. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50082 573 METER NEEDLE A needle-shaped part designed to indicate a position on a scale. C50290 3088 NEEDLE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50067 879 MICROCIRCUIT An integrated circuit containing multiple components. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50068 880 MICROPHONE A device designed to convert sound to an electrical signal. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50069 881 MICROSCOPE An optical instrument that uses a combination of lenses to produce magnified images of very small objects C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50070 882 MIRROR A device consisting of a polished surface designed to reflect light. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50071 883 MIXER A mechanical device designed to blend materials or an electronic device designed to blend signals. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA 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 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50073 885 MODULATOR An electronic device designed to vary the frequency, amplitude, or phase of an electromagnetic signal. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50074 886 MONITOR A device than includes a sensor designed to give information about the presence of a substance or the state of a system. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50076 485 MOTHERBOARD The circuit board that contains most of the processor units. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50355 3086 MOTION DETECTOR A device designed to signal the presence of excess motion in a system. C49916 787 DETECTOR FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50077 486 MOTOR A device designed to convert energy into mechanical motion. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50331 3087 MOTOR DRIVE UNIT A device consisting of a motor and accessory parts designed to power a machine. C50329 3127 UNIT FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50103 574 MOTOR ROLL PIN A pin that is formed as a rolled sheet and acts to provide a retaining force on the part through which it is inserted. C50101 906 PIN FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50079 887 MOUNT A structural device designed to facilitate the attachment of one object to another. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C54010 888 MULTIPLIER A device designed to take an input and increase some characteristic of it. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50080 889 NEBULIZER (ONLY USE WHEN PART OF ANOTHER DEVICE) A device designed to convert a liquid to a mist. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50290 3088 NEEDLE A device part with a long, slender, pointed shape. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50081 890 NETWORK A collection of two or more computers and associated devices that are linked together with communications equipment. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50083 1023 NONE An indication that there is no device or component that matches the criteria. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50291 3092 NOZZLE A device designed to regulate and direct the flow of a fluid. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50325 3093 NOZZLE TIP A device designed to form the end of a nozzle. C50324 3123 TIP FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50084 891 NUTS A threaded fastener designed to engage a bolt. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50085 487 O2 MONITOR SUBASSEMBLY (ONLY USE WHEN PART OF ANOTHER DEVICE) A sensor and circuit designed to sense the oxygen level in a space, environment, or material, as part of a larger device. C53996 3051 DEVICE SUBASSEMBLY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50168 892 O2 SENSOR A sensor designed to respond to the presence or level of oxygen in a space or environment. C50166 510 SENSOR FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50086 488 OBTURATOR A plug-like device used to close an opening in a body structure or a removable plug used during the insertion of a cannula. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50334 3094 ONE-WAY VALVE A valve designed to allow flow in only one direction. C50243 527 VALVE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49856 894 OPTICAL CABLE A cable designed to use fiberoptic strands to transmit signals. C49855 423 CABLE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49926 893 OPTICAL DISK A data storage disk where the data is stored in a format to be read optically by a laser and receiver. C49925 791 DISK FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49954 546 OPTICAL FIBER A device made with thin glass fibers as a conduit for transmission of light. C49952 814 FIBER FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50087 895 OPTOCOUPLER An electronic device designed to convert an electrical signal to an optical one or an optical signal to an electrical one, especially as part of a system to optically link circuits that are electrically isolated. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50088 896 OSCILLATOR An electronic device designed to produce a wave signal. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50089 897 OSCILLOSCOPE An electronic device designed to display electrical measurements, typically as a waveform on a cathode ray tube. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50091 898 OUTLET An opening in a device that allows something to exit, commonly used to refer to an electrical power recepticle. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50092 899 OVEN An enclosed structural device designed for heating an object. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50093 575 OVERLAY A device designed to be applied over an object, typically for protection or identification. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50065 490 OXIMETER (ONLY USE WHEN PART OF ANOTHER DEVICE) OXIMETER A device designed to measure oxygen saturation in arterial blood. C50052 462 GAUGES/METERS FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50094 491 OXYGEN ANALYZER A device designed to measure the concentration of oxygen in a gas mixture. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50095 900 PAD A protective or cushioning material applied to a projecting or supporting surface of a device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50293 3095 PALLET A device resembling a bed. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50096 901 PANEL A rigid sheet that forms a surface of a device or component. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50097 492 PC (PRINTED CIRCUIT) BOARD A circuit board that has connections that are preapplied, usually added using photo-resist and acid etching techniques. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49917 902 PHOTODETECTOR A device designed to detect light. C49916 787 DETECTOR FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50098 903 PHOTOMULTIPLIER An electronic sensing device designed to amplify low-energy light signals and convert them to electrical pulses. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50328 3096 PHOTOMULTIPLIER (PM) TUBE An electronic device designed to detect and amplify light signals. C50236 525 TUBE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50099 904 PHOTOTRANSISTOR A transistor in which incident light acts as the base activating input. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50100 905 PICKUP An electromagnetic device designed to convert movement to an electric signal. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50261 493 PILOT BALLOON VALVE A two-way valve designed to control the pressure in an endotracheal tube cuff as introduced through a pilot balloon. C50243 527 VALVE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50101 906 PIN A small, slender object designed to secure another object. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50296 3097 PIPETTE A measuring device, traditionally including a graduated tube, designed for the accurate transfer of liquid volumes. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49975 576 PISTON GUIDES A device similar to a bushing but designed to reduce the linear friction between a piston and its cylinder. C49974 829 GUIDE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49981 577 PISTON HEADS The portion of a piston above the topmost seal ring. C49980 832 HEADS FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50104 578 PISTON PADS A pad designed to fit onto the head of a piston. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50105 494 PIVOT A device designed to act as a center of rotation. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50106 907 PLATE A sheet of metal or wood or glass or plastic. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50107 908 PLOTTER A computer driven instrument designed for drawing graphs and pictures. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50108 579 PLUG A device designed to seat into an opening in a device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50297 3098 PLUNGER A mechanical device designed to slide within a chamber to transfer a material. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50109 910 POINTER An indicator device designed to show a position on a scale. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50110 911 POLARIZER An optical device that creates polarized light from incident light. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50111 495 PORT A device designed for the introduction of fluid to or removal of fluid from a system; also an electronic circuit that acts as a connection to an outside device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50112 912 POST A structural device part that supports or aligns other parts. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50064 496 POTENTIOMETER A device designed to measure a direct current electromotive force or a device designed to control the current that flows through a circuit. C50052 462 GAUGES/METERS FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49892 497 POWER CORD A flexible cable designed to connect an electric device to a power source. C49890 768 CORD FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50113 580 POWER LAMP A light designed to indicate the status of a power source or power connection. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50114 913 POWER MODULE An independent electronic device designed to supply power to other devices. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50115 498 POWER SUPPLY Any electronic device designed to supply power to other devices. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50200 499 POWER SWITCH A switch designed to regulate the power to a device. C50199 519 SWITCHES FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50116 914 PREAMPLIFIER An electronic device designed to boost the signal of a low-level input signal to an intermediate level prior to further amplification. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50117 915 PRESCALER An electronic counter device designed to reduce a very high frequency signal to a lower frequency by division. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50118 916 PRESELECTOR A preamplifier device that is designed to operate between an antenna and a receiver to improve reception. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50167 500 PRESSURE SENSOR A sensor designed to respond to the level of pressure in a space or pressing on a surface. C50166 510 SENSOR FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50119 581 PRESSURE SIGNAL A device designed to monitor or display a pressure reading. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50239 501 PRESSURE TUBING Flexible tubing designed to withstand high pressure. C50236 525 TUBE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50120 917 PRINTER An electronic device that is designed to transfer text or images to paper or other substrate. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50121 918 PROBE A device designed to reach into a location for manipulating or sensing. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50299 3099 PROBE, TRANSDUCER PRESSURE A probe device designed to convert a change in pressure into a varying electrical signal. C50121 918 PROBE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50122 919 PROCESSOR A device designed for preparing or treating a material; also the part of a computer that makes most of the calculations. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50123 920 PROGRAMMER A device designed to write instructions to a memory device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50050 503 PROM (PROGRAMMABLE READ ONLY MEMORY) A type of read only memory device that can be written to once after manufacture. C50048 509 ROM (READ ONLY MEMORY) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50124 504 PRONG Any pointed projection on a device, usually one designed to attach a device to something else. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50125 921 PROTECTOR A device or attachment designed to shield something from harm. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50203 922 PROXIMITY SWITCH A switch designed to actuate when something comes within a predetermined distance. C50199 519 SWITCHES FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50126 923 PULLEY A wheel with a groove in it designed to change the direction of force of a rope or belt that runs over it. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50127 924 PULSER A device designed to produce a short burst of signal. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50128 925 PUMP A device designed to facilitate the movement of a fluid. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C54023 3157 PUSHER A device designed to advance something by pushing it. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50063 926 PYROMETER A device designed to measure high temperatures, such as those in a furnace. C50052 462 GAUGES/METERS FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50130 927 RAIL A bar designed for support, attachment, guidance, or protection from falling. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA 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 FDA CDRH C50303 3100 RATE MODULATED PACING SENSOR A sensor for a pacemaker designed to alter the rate of heart stimulation based on the activity level of the subject. C50166 510 SENSOR FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50131 928 REACTOR A vessel in which a chemical reaction takes place or an electronic device designed to add reactance to a circuit. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50132 929 READER A device designed to capture data encoded on an object and convert it to a signal that can be input into a computer. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50133 930 RECEIVER An electronic device designed to capture an incoming electromagnetic signal and convert it to an audible or visual signal. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50330 3101 RECEIVER STIMULATOR UNIT As part of a cochlear implant, an implanted device designed to receive signal from the external device and then decode the signal and transmit it to the brain. C50329 3127 UNIT FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50134 507 RECORDER (TAPE, STRIPCHART, ETC.) A device designed to capture and store audiovisual or other data. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50135 931 RECTIFIER An electrical device designed to convert alternating current to direct current. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50136 582 REED (ELECTRICALLY OPEN) A switch device consisting of thin, flexible, magnetically controlled contacts enclosed in a sealed and evacuated enclosure. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50137 932 REGULATOR Any device designed to control a process or condition. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50138 508 RELAY An electrical circuit designed to act as a switch for another circuit. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50139 933 REPEATER An electronic device designed to receive a signal, amplify it, and resend it. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50140 934 RESERVOIR A vessel designed to store a fluid. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50141 935 RESISTOR An electronic device that opposes the flow of current. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50143 937 RESONATOR A physical device designed to resonate at a specific frequency or an electronic circuit that responds to oscillations in one circuit by setting up oscillations in another circuit. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50144 938 RETAINER A physical device designed to hold something in place. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50102 583 RETAINING PIN A pin designed to fasten one object into another. C50101 906 PIN FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50145 939 RETICLE A grid or pattern in the eyepiece of an optical device designed to establish a scale or position reference. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50146 941 RHEOSTAT A mechanical device designed to create variable resistance in a circuit based on the position of a contact on a coil. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50147 942 RIBBON Any device that consists of a long, narrow, flexible material. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50148 943 RING Any doughnut-shaped device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50151 944 RIVET A fastening device resembling a heavy pin, having a head on one end and designed to have the other end flattened after passing through the pieces to be connected. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50152 945 ROBOT A mechanical device designed to perform an automated action. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50153 946 ROD Any rod-shaped device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA 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 FDA CDRH C50154 947 SAFETY INTERLOCK A mechanical or electronic device designed to prevent one action from happening when certain conditions exist. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50155 984 SAW (SURFACE ACOUSTIC WAVE DEVICE) An electronic device designed to propagate an acoustic wave along the surface of a piezoelectric substrate as a filter, oscillator, or transformer. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50156 949 SCALE A device designed for weighing or an indicator device with a graduated sequence of divisions. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50157 948 SCALER An electronic counter device designed to output a pulse in response to a set number of input pulses. Also refers to a physical device designed to scrape hardened material from the surface of a tooth. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50158 950 SCANNER An electronic device that generates a digital representation of an image for data input to a computer or a receiver designed to search for a signal within a specified frequency range. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50062 951 SCINTILLOMETER A device designed to measure radioactivity indirectly by its ability to cause flashes of light in a sensitive material. C50052 462 GAUGES/METERS FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50159 952 SCRAMBLER An electronic device or software designed to transmit a telecommunications signal so that it is unintelligible but can be restored at the receiver. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50160 953 SCREEN An electronic device designed as a display or a physical device designed to be a protective meshwork. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50161 568 SCREW A fastener device with a tapered threaded shaft and a head designed to engage a drive device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50278 3102 SCREW HEAD The end of a screw designed to interact with a drive device. C49980 832 HEADS FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50321 3103 SCREW TAPPER A device designed to cut threads in a object C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50162 954 SCRIBER A pointed device designed to etch a mark on an object. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50163 432 SEAL A device designed to prevent passage of some material through a joint or opening. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50164 584 SEAL TRACHEAL A device component of an endotracheal tube (ET) assembly designed to provide a tight fit for the ET tube to the tracheal wall and thus an effective seal between the device and the tissue. C50163 432 SEAL FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50360 3104 SEDIMENT FILTER A filter designed to remove particles from a liquid. C49956 816 FILTER FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50166 510 SENSOR A device designed to respond to a stimulus by generating a signal that can be measured or interpreted. C50121 918 PROBE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50169 551 SERVO An electronic device designed to amplify the force of a movement. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50170 955 SHAFT A long rod. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50171 956 SHIELD A device designed to form a protective covering or structure. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50172 957 SHIFT REGISTER An electronic circuit designed to move all data to the left or right, thereby doing multiplication, division, or parallel conversion. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50173 958 SHIFTER A mechanical device designed to change the gears in a mechanism. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C76120 3105 SHOCK CAPACITOR The component of a defibrillator designed to store the electical charge before it is delivered to the patient. C49862 555 CAPACITOR FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50305 3106 SHOULDER SUPPORT A device designed to support an object as it sits on the shoulder or an orthopedic device designed for rehabilitation after a shoulder injury. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50174 959 SHUNT An implantable device designed to drain fluid from a body cavity. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50175 960 SHUTTER A mechanical or electronic device designed to regulate an exposure time, especially the one in a camera. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50301 3107 SIDE RAIL A supportive or protective rail attached to the side of something. C50130 927 RAIL FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50176 961 SIGNAL CONDITIONER An electronic device or circuit designed to take an input signal and offset, attenuate, amplify, and/or filter the output signal. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50177 962 SIMULATOR A device designed to create a test or training environment that approximates actual conditions. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50178 963 SLIDE A flat rectangular piece of glass on which specimens can be mounted for microscopic study. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50149 964 SLIP RING A ring-shaped electrical contact designed to provide connection to a rotating part. C50148 943 RING FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50179 965 SLOTTER LINE A device designed to make a longitudinal cut through the protective cladding of a fiber bundle without harming the fibers. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50180 967 SOCKET A device designed as an opening into which something else fits. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49809 966 SOCKET ADAPTOR A device designed to allow an incompatible plug to connect with another device. C49808 431 ADAPTER (ADAPTOR) FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50014 511 SOLDER JOINT A connection between objects formed by solder. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50181 512 SOLENOID An electronic device consisting of a coil surrounding a movable iron core that is designed to act as a switch or relay. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49805 968 SOUND ABSORBER A device or material designed to attenuate sound energy. C50372 3028 ABSORBER FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50182 969 SPACER A device designed to position objects further apart. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50183 970 SPARK GAP An electronic device consisting of electrical contacts separated by a gap across which a spark will form when the voltage is high enough. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50184 971 SPEAKER A device designed to convert electrical signals to sounds that can be heard. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50061 972 SPECTROMETER A device designed to measure wave lengths and angles of deflection of an electromagnetic radiation source, generating a spectrum plot across frequencies. C50052 462 GAUGES/METERS FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50306 3108 SPEECH PROCESSOR An electronic device designed to convert speech sounds into electrical signals, especially as part of a cochlear implant. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50066 514 SPIROMETER A device designed to measure lung capacity. C50052 462 GAUGES/METERS FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50185 973 SPLICER A device designed to join pieces of a material into a continuous length. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50186 974 SPOOLER An electronic device designed to set files into a queue for processing, especially one for controlling the output to a printer. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50187 975 SPRING An elastic device designed to bend under a load and then return to its shape when unloaded. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50288 3109 SPRING LOADING MECHANISM A device that uses a spring to deliver something into a device or system. C50285 3085 MECHANISM FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50188 976 STABILIZER A device designed to reduce unwanted movement. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50189 977 STAND A support device designed to hold an object. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50307 3110 STAPLE A fastening device consisting of a bent wire designed to pierce and hold. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50337 3111 STEERING WIRE A wire designed to connect to a steering device. C50269 430 WIRE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50190 515 STENT A device designed to support a tubular structure, especially the small stainless steel expandable mesh tube inserted within an artery. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50078 516 STEPPER MOTOR A motor designed to rotate in fixed increments. C50077 486 MOTOR FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50191 978 STIFFENER A material or device designed to stiffen an object. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50192 517 STOPCOCK A rotating device designed to act like a faucet for regulating the flow of a fluid. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50333 3112 STOPCOCK VALVE A rotating valve designed to regulate the flow of a fluid through a stopcock. C50243 527 VALVE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50193 979 STRAIN RELIEF A structure designed to fuction with a connector to prevent damage to a hose or cable from excess flexing. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50194 980 STRIP LINE A conductor cable designed as a thin, flexible ribbon of metals separated by an insulating layer. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50195 518 STYLET A thin metal wire designed to be passed through a needle, catheter, or cannula to stiffen it or clear it of debris. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50196 981 SUBSTRATE C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50197 982 SUNLAMP A lamp designed to emit ultraviolet radiation. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50198 983 SUPPRESSOR An eletrical device designed to reduce or eliminate unwanted currents. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50364 3113 SURGICAL GRAFT A tissue or organ surgically moved from a donor to a recipient or from site to site of an individual. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50365 3114 SUTURE A natural (e.g., catgut, silk, or linen) or synthetic, or other (e.g., thin metal wire) monofilament or multifilament material used surgically to close a surgical or accidental wound and to secure apposition of the edges and join tissues. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C54013 3154 SWITCH, PUSH BUTTON A switch designed to be operated by pressing a button. C50199 519 SWITCHES FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50199 519 SWITCHES A mechanical or electronic device designed to break or change the connections in a circuit. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50205 985 SYNCHRONIZER A mechanical device on a transmission designed to make the gears spin at the same speed. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50206 986 SYNTHESIZER C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50207 987 SYRINGE A device designed as a rigid cylinder with a plunger at one end and a delivery opening at the other. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50310 3115 SYRINGE DRIVE A device designed to advance a syringe plunger at a specified rate, used to administer continuous subcutaneous infusions. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50311 3116 SYSTEM A group of independent but interrelated devices working together. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50371 3117 TABLE A piece of furniture having a smooth flat top that is usually supported by one or more vertical legs, or any object of a similar appearance. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50320 3118 TABLE TOP The uppermost, flat surface of a table. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50060 989 TACHOMETER A device designed to measure a speed of rotation. C50052 462 GAUGES/METERS FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50209 990 TAPE A long, thin, flat, flexible material often used for measuring, binding or fastening, or as a recording medium. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50210 991 TEE A device designed to be used for transesophogeal echocardiogram (TEE). C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50211 520 TELEMETRY EQUIPMENT Equipment designed to transmit and receive data from a remote source using telecommunications methods. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50212 992 TELEPHONE Electronic equipment that converts sound into electrical signals that can be transmitted over distances and then converts received signals back into sounds. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50213 993 TELEPRINTER A character printer that transmits and receives text and data using telecommunications methods and operates like a typewriter. It has been largely replaced by high-speed data printers. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50214 994 TELETYPEWRITER A character printer that transmits and receives text and data using telecommunications methods and operates like a typewriter. It has been largely replaced by high-speed data printers. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50242 995 TELEVISION UNIT An electrical device designed to receive a television signal and display an image. C50329 3127 UNIT FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50215 996 TEMPERATURE COMPENSATOR A device designed to vary the temperature of one system in response to temperature changes in another system or the environment. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50300 3119 TEMPERATURE PROBE A remote sensor designed to respond to the temperature of a space, surface, or environment. C50121 918 PROBE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50304 3120 TEMPERATURE SENSOR A sensor designed to respond to the temperature of a space, surface, or environment. C50166 510 SENSOR FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50216 997 TERMINAL An electronic device designed to provide access to a computer. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50217 585 TERMINAL ASSEMBLY A part of a device that includes a terminal as part of a larger device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50218 998 TERMINATOR A device designed to connect to the end of a bus network. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50322 3121 TEST STRIP A piece of chemically treated medium designed to react in the presence of specific amounts of a trigger substance. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50219 999 THERMISTOR A type of resistor designed from materials whose resistance varies as a function of temperature. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50220 1000 THERMOCOUPLE A device designed for temperature acquisition consisting of two wires of different metals that are joined at both ends. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50270 547 THERMOCOUPLE WIRE A wire designed for temperature acquisition as part of a thermocouple. C50269 430 WIRE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50059 3158 THERMOMETER A device designed to measure temperature. C50052 462 GAUGES/METERS FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50221 3159 THERMOSTAT A device designed to regulate temperature by controlling the starting and stopping of a heating/cooling system. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50323 3122 THREAD A fine cord typically used for sewing. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50222 3135 THYRISTOR A semiconductor component that is similar to a diode but that can be switched on to pass current. Once it is on it will remain on until the current flow drops below a threshold. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50223 3136 TIMER A device designed to measure a time interval. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50324 3123 TIP The extreme end of something, especially something pointed. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49879 586 TIP CONDUCTOR COIL A coil associated with a tip conductor voltage tester. C49877 761 COIL FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50294 3124 TOMOGRAPHIC PALLET The part of a tomography machine on which the subject lays. C50293 3095 PALLET FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50350 3125 T-PIECE CONNECTOR A device, usually for connecting tubing, that resembles the letter T. C49885 435 CONNECTOR FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50224 3137 TRACKBALL An electronic pointing device that incorporates a rotatable ball designed to detect motion of the ball in two dimensions. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50225 3138 TRANSCEIVER An electronic device designed to be both a transmitter and a receiver. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50226 522 TRANSDUCER An electrical device that converts one form of energy into another. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA 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 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50228 524 TRANSISTOR A semiconductor component with three terminals that is designed to amplify a signal. It is the fundamental component of all modern circuitry. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50229 3139 TRANSLATOR A device designed to convert computer code or signals from one one type to another. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50230 3140 TRANSMISSION LINE A conductor designed to transfer power or signal from one location to another. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50231 3141 TRANSMITTER A device to propagate electromagnetic waves. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50232 3142 TRANSPONDER An electrical device designed to send a specific response upon receiving a specific signal. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50233 3143 TRANSPORT Any device designed to move something. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50234 3144 TRIAC THREE TERMINAL CURRENT CONTROLLING SEMICONDUCTOR A bidirectional thyristor designed to control AC power. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50235 3145 TRIMMER A capacitor having variable capacitance or a device designed to cut something to size. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50327 3126 TROCAR A sharp, pointed rod designed to pierce the wall of a body cavity to withdraw fluid or allow placement of a catheter or other device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50236 525 TUBE Any device or component shaped like a hollow cylinder. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50237 587 TUBE CAPILLARY A tube with a narrow diameter designed to hold a liquid by capillary action. C50236 525 TUBE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50240 3146 TUNER An electronic receiver designed to capture signals of a selected frequency for amplification. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50329 3127 UNIT A largely self-contained device designed to be incorporated into a larger device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C54008 444 USER INTERFACE A computer program that controls the interaction between a user and a system. C50008 848 INTERFACE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50243 527 VALVE VALVE (ONE-WAY, HEMO, STOPCOCK, ETC.) A mechanical device designed to control the flow of a fluid. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C54016 3155 VALVE CAM A rotating disk attached to a shaft designed to control the opening and closing of a valve. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50244 529 VALVE, CONTROL A valve designed to regulate the flow of a fluid, especially one designed to operate in response to a signal from a control system. C50243 527 VALVE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50245 530 VALVE, DIRECTIONAL A valve designed to control the flow of fluid in a hydrolic system. C50243 527 VALVE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50246 589 VALVE, DUMP A outflow valve designed to quickly empty a system. C50243 527 VALVE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50247 531 VALVE, EXHALATION A valve designed to allow the escape of exhaled gases from a respirator or respiration system. C50243 527 VALVE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50248 532 VALVE, FLAP A valve that is hinged on one edge. C50243 527 VALVE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50249 533 VALVE, FLOW A valve designed to regulate the flow of fluid, especially one designed to prevent flow when a certain flow rate is exceeded. C50243 527 VALVE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50250 534 VALVE, INHALATION A valve designed to regulate the flow of gases into a respirator or respiration system. C50243 527 VALVE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50251 535 VALVE, INLET PORT A valve that controls the flow of fluids in through the wall of a chamber. C50243 527 VALVE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50252 536 VALVE, INSPIRATORY A valve designed to regulate the flow of gases into a respirator or respiration system. C50243 527 VALVE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50253 537 VALVE, OUTLET PORT A valve designed to control the flow of fluids out through the wall of a chamber. C50243 527 VALVE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50254 538 VALVE, PEEP (POSITIVE END EXPIRATORY PRESSURE) A valve designed to work on a positive airway pressure device to maintain the positive pressure at the end of the respiratory cycle. C50243 527 VALVE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50255 539 VALVE, PRESSURE LIMIT A valve designed to automatically open in order to maintain the pressure in a system below a specified pressure. C50243 527 VALVE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50256 540 VALVE, RELIEF A valve designed to automatically open in order to maintain the pressure in a system below a specified pressure. C50243 527 VALVE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50257 541 VALVE, SAFETY A valve designed to automatically open in order to maintain the pressure in a system below a specified pressure. C50243 527 VALVE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50258 542 VALVE, SELECTOR A valve designed to control which of several ports will be connected to a system. C50243 527 VALVE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50262 543 VAPORIZER A device designed to convert a solution to an aerosol or mist, especially one to prepare a medication for inhaling. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50263 3147 VARISTOR A semiconductor resistor device designed to have a voltage-dependent nonlinear resistance where resistance drops as the applied voltage increases. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50264 588 VDT (VIDEO DISPLAY TERMINAL) A device incorporating a cathode ray tube, a keyboard and a computer connection designed to render data from a computer system. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50265 3148 VIBRATOR A mechanical device designed to create a vibratory motion. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50266 3149 VIEWER C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50058 1018 VOLTMETER A device designed to measure the voltage potential difference between points in a circuit. C50052 462 GAUGES/METERS FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50267 3150 WASHER A device designed to cleanse an object, or a flattened disk used as a mechanical seal between objects. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50315 3128 WATER PURIFICATION SYSTEM A system designed to remove unwanted substances from water. C50311 3116 SYSTEM FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49976 3151 WAVEGUIDE A material and device designed to guide and shape an electromagnetic wave. C49974 829 GUIDE FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50361 3129 WEDGE FILTER A filter designed so that its thickness or transmission properties increase from one edge to another. C49956 816 FILTER FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C89532 3195 WELD Any joining connection that is the result of welding 2 or more parts. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C51067 3130 WHEEL A mechanical device consisting of a spoked, circular rim or solid disk designed to rotate on an axle or shaft. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C51069 3131 WHEELCHAIR, TIRES A tire designed to be mounted on a wheelchair wheel. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C51068 3132 WHEELCHAIR, WHEELS A wheel designed to be used on a wheelchair. C51067 3130 WHEEL FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50268 3152 WINDOW A transparent panel in a device designed for visual inspection. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50269 430 WIRE A metal strand designed for signal or power transmission or for structural or other purpose. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50272 544 WIRING HARNESS A collection of grouped wires or cables designed to connect to a specific device. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C50273 3153 YOKE A structural device designed to connect multiple objects. C49755 3049 DEVICE COMPONENT OR ACCESSORY FDA C54577 Medical Device Component Or Accessory Terminology FDA CDRH C49886 545 Y-PIECE CONNECTOR A device, usually for connecting tubing, that resembles the letter Y. C49885 435 CONNECTOR FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91867 10 CANNOT COMPLETE INVESTIGATION, INCOMPLETE DEVICE RETURNED C91894 67 UNABLE TO CONFIRM COMPLAINT FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91868 11 CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS The device is undergoing an evaluation but has not yet been completed. C54030 17 EVALUATION CONCLUSION FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91869 12 DESIGN DEFICIENCY The device problem was traced back to the design specifications (e.g. in the requirements, testing processes, hazard analysis, implementation strategy). C91885 25 QUALITY SYSTEM DEFICIENCY FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91870 13 DEVICE DIFFICULT TO OPERATE Device problems including set-up, operation, and disassembly of equipment. C91874 19 HUMAN FACTORS ISSUE FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91871 70 DEVICE DISCARDED BY USER, UNABLE TO FOLLOW-UP C91894 67 UNABLE TO CONFIRM COMPLAINT FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91872 50 DEVICE FAILURE RELATED TO PATIENT CONDITION A device problem that occurred in part or in total related to the patient's physiology. C91874 19 HUMAN FACTORS ISSUE FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91876 14 DEVICE INCORRECTLY PREPARED FOR USE OR MODIFIED A device that is incorrectly modified or prepared for use by distributor, service provider, or user facility. C91874 19 HUMAN FACTORS ISSUE FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91882 15 DEVICE NOT MANUFACTURED BY REPORTING FIRM C91894 67 UNABLE TO CONFIRM COMPLAINT FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91883 92 DEVICE NOT RETURNED C91894 67 UNABLE TO CONFIRM COMPLAINT FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91886 94 DEVICE RECEIVED IN CONDITION MAKING EVALUATION IMPOSSIBLE C91894 67 UNABLE TO CONFIRM COMPLAINT FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91887 16 DEVICE RECEIVED UNUSED IN ORIGINAL PACKAGE C91894 67 UNABLE TO CONFIRM COMPLAINT FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91888 63 DEVICE REPAIRED AND RETURNED The device was repaired and returned to the user (reporter) following a reported device problem. C91885 25 QUALITY SYSTEM DEFICIENCY FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C54030 17 EVALUATION CONCLUSION C62596 FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91873 18 FAILURE TO FOLLOW INSTRUCTIONS A device problem related to the user not following the manufacturer's instructions. C91874 19 HUMAN FACTORS ISSUE FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91874 19 HUMAN FACTORS ISSUE C54030 17 EVALUATION CONCLUSION FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91875 20 INCONCLUSIVE-INVESTIGATION IN PROGRESS C91894 67 UNABLE TO CONFIRM COMPLAINT FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91877 21 INFRASTRUCTURE FAILURE Device problems related to problems with the underlying framework, systems, and processes of an organization (e.g. as building power supply, network, oxygen systems). C54030 17 EVALUATION CONCLUSION FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91878 22 KNOWN INHERENT RISK OF PROCEDURE Device problems known and documented in the labeling (including both short or long term known complications or adverse reactions). C54030 17 EVALUATION CONCLUSION FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91879 57 LABELING DEFICIENCY Device problems that occur as the result of problems with the labeling (including package inserts, instruction manuals, instructions for use). C54030 17 EVALUATION CONCLUSION FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91880 51 MAINTENANCE DEFICIENCY Device problems that result from improper routine or preventative maintenance. C91885 25 QUALITY SYSTEM DEFICIENCY FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91881 23 MANUFACTURING DEFICIENCY The device problem was traced back to the manufacture of the device as opposed to systems used to control the manufacture of the device (quality system). Examples include problems with construction or assembly. C91885 25 QUALITY SYSTEM DEFICIENCY FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91890 71 NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION C91894 67 UNABLE TO CONFIRM COMPLAINT FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91891 75 NO FAILURE DETECTED, DEVICE OUT OF SPECIFICATION C91894 67 UNABLE TO CONFIRM COMPLAINT FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91892 24 OFF-LABEL, UNAPPROVED, OR CONTRAINDICATED USE Device problems related to its use during an unapproved procedure, in an unapproved patient, or for which it is contraindicated, or not listed on the label. C54030 17 EVALUATION CONCLUSION FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91884 77 OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO EVENT A device problem related to the operator's technique or use environment. C91874 19 HUMAN FACTORS ISSUE FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91885 25 QUALITY SYSTEM DEFICIENCY A defect in the processes or systems used in the design and manufacture of the device. Examples include problems within the change control, production, or quality control processes. C54030 17 EVALUATION CONCLUSION FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91893 26 REUSE OF SINGLE USE DEVICE Device problems related to the use of a device more than once when it is designed for only one use. C54030 17 EVALUATION CONCLUSION FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91889 27 TRAINING DEFICIENCY A device problem related to inadequate training. C54030 17 EVALUATION CONCLUSION FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91894 67 UNABLE TO CONFIRM COMPLAINT The device complaint or problem cannot be confirmed. If possible, choose a more specific reason from among the terms listed in this branch of the hierarchy. C54030 17 EVALUATION CONCLUSION FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91895 61 USE ERROR CAUSED OR CONTRIBUTED TO EVENT The interaction between the device and the user caused or contributed to the error. This includes inappropriate use of the device or failure to appropriately maintain the device. C91874 19 HUMAN FACTORS ISSUE FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91898 3261 ACOUSTIC ENERGY TESTING Testing the device for its response to variations in air pressure produced by the vibration of an object. C91963 26 MECHANICAL EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91899 3262 ACOUSTIC NOISE TESTING Testing the device's response to variations in air pressure for detecting any unwanted or unintentional sound. C91898 3261 ACOUSTIC ENERGY TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91896 10 ACTUAL DEVICE EVALUATED C54028 3291 EVALUATION METHOD FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91897 3263 ACTUAL DEVICE NOT EVALUATED C54028 3291 EVALUATION METHOD FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91900 3264 AGENT CONTAMINATION TESTING Testing the device for the presence of chemicals or other agents that do not belong on the device (contamination). C91912 3277 CONTAMINATION TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91901 3265 AGGLUTINATION TESTING Evaluating the device for characteristics that may cause blood to clot. C91938 3298 HEMATOLOGIC TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C102867 3372 ANALYSIS OF DATA LOG(S) Analysis of device log data such as error or keystroke log, or device alarm history A record of data captured about device logging functions, error logs, keystroke logs and device alarm history. C91993 22 SOFTWARE EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91902 3266 ASSEMBLY AND PACKAGING REVIEW Performing a review of the assembly and packaging processes and records for a specific device or lot that may have contributed to problems with the device. C91978 3331 PROCESS EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91903 3267 BIOASSAY EVALUATION Measuring the effects of a substance on a living organism. Bioassays may be qualitative or quantitative. Qualitative bioassays are used for assessing the physical effects of a substance that may not be quantified, such as abnormal development or deformity. C91905 3269 BIOLOGIC EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91904 3268 BIOCOMPATIBILITY TESTING Testing the device to determine if it elicits an undesirable local or systemic biological effect in the cells or tissues of the recipient of that device. This includes testing the device for its toxicity to cells. C91905 3269 BIOLOGIC EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91905 3269 BIOLOGIC EVALUATION C54028 3291 EVALUATION METHOD FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91906 3270 CARCINOGENIC TESTING Testing the device's ability to promote cancer or facilitate its propagation. C91934 3294 GENOTOXIC TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91907 3271 CELL EVALUATION Evaluating a device's characteristics that may affect cells. C92015 3364 TISSUE ENGINEERING EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91997 3273 CODE REVIEW A systematic review of source code intended to find and fix mistakes possibly overlooked in the initial development phase. C91993 22 SOFTWARE EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91998 3272 CODE VALIDATION Ensuring that common error patterns and violations of best practices in coding have been followed. C91995 3347 SOFTWARE VALIDATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91908 3274 COMPLEMENT ACTIVATION TESTING Evaluating a device's ability to activate the process of clearing pathogens from a organism. C91938 3298 HEMATOLOGIC TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91909 3275 COMPOSITION TESTING Testing the device to determine if the correct combination of materials or elements is present (e.g., the composition of the materials of a capacitor). C91961 3318 MATERIALS AND CHEMISTRY EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91910 28 COMPRESSION TESTING Testing the device for problems that can occur as the result of excessive stress or pressure applied to the device resulting in its compaction (decrease of volume). C92005 3355 STRESS TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91911 3276 CONDUCTED EMISSIONS TESTING Testing the ability of a device's conducted emissions to cause another device to fail (i.e. electromagnetic disturbance for which the energy is transferred via one or more conductors). C91925 3289 EMISSIONS TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91912 3277 CONTAMINATION TESTING Testing the device to detect the presence of any substance that can cause infection or fever. C91905 3269 BIOLOGIC EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91913 3278 CREEP (STRENGTH) TESTING Testing the device's ability to withstand a constant tensile load at elevated temperatures. (Creep is the form of plastic deformation that takes place in steel held for long periods at high temperature.) C92005 3355 STRESS TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91914 3279 CURRENT LEAKAGE TESTING Testing to detect the amount of electricity leakage from the device. C91919 23 ELECTRICAL EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91915 3280 DATA VALIDATION Ensuring that data used and generated by a program is correct. C91993 22 SOFTWARE EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91916 3281 DEGRADATION/CORROSION/EROSION TESTING Testing the device for its corrosive behavior to specific environments or materials. Tests may include polarization, potentiostatic, galvanic, critical pitting/crevice temperature, and inhibitor testing. C91961 3318 MATERIALS AND CHEMISTRY EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91917 3282 DESIGN VALIDATION Validating that the device meets the user's needs and intended uses. C91995 3347 SOFTWARE VALIDATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91931 13 DEVICE FROM CONTROLLED OR NON-RELEASED SAMPLE EVALUATED C91897 3263 ACTUAL DEVICE NOT EVALUATED FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91932 12 DEVICE FROM RESERVE SAMPLE EVALUATED C91897 3263 ACTUAL DEVICE NOT EVALUATED FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91933 11 DEVICE FROM SAME LOT EVALUATED C91897 3263 ACTUAL DEVICE NOT EVALUATED FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92006 39 DEVICE STRUCTURE TESTING Testing devices for problems related to the presence of an inappropriate molecular geometry somewhere in the device (i.e., the spatial arrangement of atoms in a molecule and the chemical bonds that hold the atoms together). C91961 3318 MATERIALS AND CHEMISTRY EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92016 34 DEVICE-TO-DEVICE INTERACTION TESTING Tests conducted to assess the mechanical, electrical, or electronic compatibility of two or more devices. C91951 20 INTEROPERABILITY EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92017 35 DEVICE-TO-HUMAN INTERACTION TESTING Tests conducted to assess the interaction between a device and the user C91951 20 INTEROPERABILITY EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91918 3283 ELASTICITY TESTING Testing the device's ability to recover its size and shape after being deformed during the test. C92005 3355 STRESS TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91919 23 ELECTRICAL EVALUATION C54028 3291 EVALUATION METHOD FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91920 3284 ELECTRICAL FAST BURST TESTING Testing the device for failures related to interference voltage tests which are bursts of electrical pulses (e.g. when a switch is turned on or off or the device is plugged in or out). C91942 3301 IMMUNITY TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91921 3285 ELECTRICAL SLOW FLUCTUATION TESTING Testing the device to detect malfunctions caused by a sudden reduction of the voltage at a particular point in an electricity supply system below a specified "dip" threshold followed by its recovery after a brief interval. C91942 3301 IMMUNITY TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91922 3286 ELECTROMAGNETIC COMPATIBILITY (EMC) EVALUATION Evaluating a device to detect malfunctions caused by electromagnetic interference (unwanted disturbances from an external force e.g. radios, cell phones, or unintentional disturbances of another device) C54028 3291 EVALUATION METHOD FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91923 3287 ELECTRON MICROSCOPY Inspection of objects or surfaces requiring magnification using an electron microscope. C91965 3321 MICROSCOPIC INSPECTION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91924 3288 ELECTROSTATIC DISCHARGE TESTING Testing the device for malfunctions related to the transfer of an electrostatic charge (by direct contact or from electrostatic fields) between objects of different potentials. C91942 3301 IMMUNITY TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91925 3289 EMISSIONS TESTING Testing the device for adequately controlled electromagnetic emissions. C91922 3286 ELECTROMAGNETIC COMPATIBILITY (EMC) EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91926 3290 ENVIRONMENT EVALUATION Evaluating devices for responses to physical characteristics in their surroundings. C54028 3291 EVALUATION METHOD FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C54028 3291 EVALUATION METHOD C62596 FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91927 27 FATIGUE TESTING Testing the device's capability to withstand the progressive and localized structural damage that occurs when a material is subjected to cyclic loading. This is a dynamic mechanical test for wear or fatigue. C92005 3355 STRESS TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91928 89 FLOW TESTING Testing the device to assess the volume of fluid moving per unit of time. This may also include filter testing. C91963 26 MECHANICAL EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91929 3292 FLUID PRESSURE TESTING Testing the fluid pressure (pressure at some point within a fluid e.g. water or air) within a device. C91963 26 MECHANICAL EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91930 3293 FRACTURE TOUGHNESS TESTING Testing the device's ability to resist local separation into two, or more, pieces under the action of stress. C92005 3355 STRESS TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91934 3294 GENOTOXIC TESTING Testing the device's ability to cause damage to genetic material. (e.g., leading to outgrowths -- malignant tumors). C91905 3269 BIOLOGIC EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91935 3295 GRADIENT-INDUCED FIELD EFFECT TESTING Testing the RF shield around the coils of an MRI device for its ability to provide effective screening against electrical (eddy) currents induced by gradient switching. C91982 3336 RADIOGRAPHIC INSPECTION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91936 3296 GROWTH FACTOR EVALUATION Evaluating a device's characteristics that may affect the self healing ability of an organism. C92015 3364 TISSUE ENGINEERING EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91937 3297 HARDNESS TESTING Testing the device's ability to resist deformation. Hardness is the property of a material that enables it to resist plastic deformation, usually by penetration. However, the term hardness may also refer to resistance to bending, scratching, abrasion or cutting. The usual method to achieve a hardness value is to measure the depth or area of an indentation left by an indenter of a specific shape, with a specific force applied for a specific time. C92005 3355 STRESS TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91938 3298 HEMATOLOGIC TESTING Testing the device for its affect or impact on the blood or its components. C91905 3269 BIOLOGIC EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91939 82 HUMIDITY TESTING Testing the device's protective materials to prevent moisture penetration or ingress. C91926 3290 ENVIRONMENT EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91940 3299 IMAGE ARTIFACT TESTING Testing an imaging device to determine the amount of distortion or signal loss (artifacts) produced in an image. C91983 3337 RADIOLOGIC EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91941 3300 IMAGE INSPECTION Macroscopic inspection commonly used to describe physical objects that are measurable and observable by the naked eye. C92023 38 VISUAL INSPECTION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91942 3301 IMMUNITY TESTING Testing the device for adequate immunity or capability to resist electromagnetic interference (EMI). C91922 3286 ELECTROMAGNETIC COMPATIBILITY (EMC) EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91943 3302 IMPACT TESTING Testing the device's response to a suddenly applied stress. The test ascertains whether the material is tough or brittle. C92005 3355 STRESS TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91944 3303 IMPEDANCE TESTING Testing the resistance to current flow in a device's circuit or component. C91919 23 ELECTRICAL EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91945 3304 IN SITU OBSERVATION Observing the device in the exact same conditions and setting in which the device was used. C92020 3367 USE TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91946 3305 INFRASOUND TESTING C91898 3261 ACOUSTIC ENERGY TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91947 3306 INGRESS PROTECTION TESTING Testing the device's ability to protect against ingress or access of unwanted fluids or solids. C91963 26 MECHANICAL EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91948 3307 INSTALLATION REVIEW Performing a review of the processes used to install a device and the records reflecting these processes performed for a specific device. C91978 3331 PROCESS EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91949 3308 INSULATION TESTING Testing the ability of a device's or component's material to resist the flow of electric current. C91919 23 ELECTRICAL EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91950 3309 INTERFERENCE SUBSTANCE TESTING A test used with in vitro diagnostic analytic systems to detect substances that may be interfering with test results and causing errors. C91905 3269 BIOLOGIC EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91951 20 INTEROPERABILITY EVALUATION Testing devices for problems with the mechanical, electrical, or communication interface between two or more separate devices or components. C54028 3291 EVALUATION METHOD FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91952 3310 IONIZING RADIATION TESTING Testing that ionizing radiation is delivered at the appropriate energy and dose to the appropriate region of interest for the exam or therapy under evaluation. C91983 3337 RADIOLOGIC EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91953 36 LABELING EVALUATION Reviewing all labeling (including instructions for use, manuals, and packaging) for language related to reported device problems. C54028 3291 EVALUATION METHOD FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91954 3311 LIGHT SOURCE PERFORMANCE EVALUATION Testing the optical properties of a device such as diopter, glare, and irradiance or glistening. C54028 3291 EVALUATION METHOD FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91955 3312 LIGHT TESTING Testing the device's characteristics when subjected to variations of ambient light within its surroundings. C91926 3290 ENVIRONMENT EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91956 3313 LINE VOLTAGE TESTING Tests to determine whether a device's insulation has the strength to prevent any current from reaching the operator. C91919 23 ELECTRICAL EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91957 3314 MAGNETICALLY-INDUCED DISPLACEMENT FORCE TESTING Testing the static magnetic field gradients on medical imaging devices for their ability to move objects. C91983 3337 RADIOLOGIC EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91958 3315 MAGNETICALLY-INDUCED TORQUE TESTING Testing the static magnetic field gradients on medical imaging devices for their ability to rotate objects. C91983 3337 RADIOLOGIC EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91959 3316 MAINTENANCE REVIEW Performing a review the technical and corresponding administrative actions and records intended to retain an item in, or restore it to, a state in which it can perform its required function. This evaluation includes reviewing the user's maintenance procedures and processes as to whether they were followed. C91978 3331 PROCESS EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91960 3317 MANUFACTURING REVIEW Performing a review of the manufacturing steps and processes to ensure that they were met and followed and that the device records reflected these processes. C91978 3331 PROCESS EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91962 3319 MATERIAL OR MATERIAL LEACHATE PYROGENIC TESTING Testing the device for the presence of unwanted agents (e.g. pyrogens) caused by materials that permeate through the device. C91912 3277 CONTAMINATION TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91961 3318 MATERIALS AND CHEMISTRY EVALUATION Testing devices for malfunctions that arise from problems with its components or materials or how its materials or components react to other elements either within the device or within the environment. C54028 3291 EVALUATION METHOD FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91963 26 MECHANICAL EVALUATION Testing the device for problems that result from external forces including fluids, other objects, or environmental or physiologic influences. C54028 3291 EVALUATION METHOD FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91964 3320 MICROBIAL CONTAMINATION TESTING Testing the device for the presence of microorganisms such as bacteria, viruses, and fungi (yeasts and molds). C91912 3277 CONTAMINATION TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91965 3321 MICROSCOPIC INSPECTION Inspection of objects or surfaces requiring magnification using a microscope e.g. with electron, optical, or scanning probe microscopy. C92023 38 VISUAL INSPECTION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91966 3322 MUTAGENIC TESTING Testing the device's ability to change genetic information (usually DNA) of an organism and thus increasing the frequency of mutations. C91934 3294 GENOTOXIC TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91967 3323 NO TESTING METHODS PERFORMED Testing was not performed on the device. C91897 3263 ACTUAL DEVICE NOT EVALUATED FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91968 84 OPTICAL MICROSCOPY Inspection of objects or surfaces requiring magnification using an optical microscope. C91965 3321 MICROSCOPIC INSPECTION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91969 3324 OVERCURRENT PROTECTION TESTING Testing the device's over-current protection circuitry for its response to situations of overload, short circuit, or ground fault. C91919 23 ELECTRICAL EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91970 3325 PACKAGING VERIFICATION Verifying that the device packaging met proper sterilization conditions and that the effectiveness of the packaging kept the device free viable microorganisms. C92002 3352 STERILIZATION PROCESS REVIEW FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91971 83 PATHOLOGICAL EXAMINATION Examining material that may have contributed to the disease or damage. Often performed using a microscope by measuring structural changes that occur along with the disease or damage. C91905 3269 BIOLOGIC EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91972 37 PHOTOGRAPHIC INSPECTION C91941 3300 IMAGE INSPECTION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91973 3326 PHYSICAL STRUCTURE TESTING Testing the device for problems related to the incorrect or inadequate arrangement of the parts, components, elements, or materials. C91961 3318 MATERIALS AND CHEMISTRY EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91974 3327 PLATELET ACTIVATION TESTING Testing the device for characteristics that lead to the activation of platelets which are essential to stop bleeding and repair the tissue. Platelets also play a key role in the development of acute coronary syndromes and contribute to cerebrovascular events. C91938 3298 HEMATOLOGIC TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91975 3328 POWER FREQUENCY MAGNETIC FIELD TESTING Tests performed to verify a device's level of protection (immunity) against magnetic disturbances while operating. C91942 3301 IMMUNITY TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91976 3329 POWER SOURCE TESTING Testing the power sources in a device e.g., battery, internal power supply to detect any malfunction. C91919 23 ELECTRICAL EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91977 3330 PRESSURE TESTING Testing the device's characteristics when subjected to high or low pressure conditions. C91926 3290 ENVIRONMENT EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91978 3331 PROCESS EVALUATION Performing a review of the manufacturing and production processes and/or records for a specific device or lot that may have contributed to problems with a device. C54028 3291 EVALUATION METHOD FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91979 3332 QUALITY CONTROL REVIEW Performing a review of the processes used in developing systems to ensure that products are designed and produced and services are developed to meet or exceed device specifications and customer expectations. C91978 3331 PROCESS EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91980 3333 RADIATED EMISSIONS TESTING Testing the ability of a device's radiated emissions to cause another device to fail (i.e. electromagnetic disturbance for which the energy is transferred through space in the form of electromagnetic waves). C91925 3289 EMISSIONS TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91988 3341 RADIOFREQUENCY INDUCED HEAT TESTING Testing the static magnetic field gradients on medical imaging devices for their ability to induce heat in objects. C91983 3337 RADIOLOGIC EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91981 3335 RADIOFREQUENCY INTERFERENCE TESTING Testing the device to detect device malfunctions caused by a disturbance affecting an electrical circuit due to electromagnetic radiation emitted from an external source. This includes susceptibility to interference via cables or air. C91942 3301 IMMUNITY TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91982 3336 RADIOGRAPHIC INSPECTION C91941 3300 IMAGE INSPECTION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91983 3337 RADIOLOGIC EVALUATION Evaluating the safety provisions in a device used for medical imaging, i.e., if the device can cause injury to individuals during imaging process (visualizing the structure and function of the body). C91919 23 ELECTRICAL EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91984 3338 REACTIVITY TESTING Testing the device for problems related to how the materials react to other factors (e.g. over-react or under-react). C91961 3318 MATERIALS AND CHEMISTRY EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91985 3339 REPRODUCTIVE TOXICITY EVALUATION Evaluating a device for chemicals or other agents that may have caused problems with the reproductive system. This includes evaluating a device for chemicals or agents that may have caused or contributed to birth defects or malformations (teratogenic evaluation). C91905 3269 BIOLOGIC EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91986 95 RESERVE SAMPLE FROM DIFFERENT LOT TESTED, NO FAILURE DETECTED C91932 12 DEVICE FROM RESERVE SAMPLE EVALUATED FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91987 3340 RESERVE SAMPLE TESTED FROM SAME LOT, NO FAILURE DETECTED C91932 12 DEVICE FROM RESERVE SAMPLE EVALUATED FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91989 3342 SCAFFOLD EVALUATION Evaluating a device's characteristics for its affects on the reproduction of tissues. C92015 3364 TISSUE ENGINEERING EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91990 3343 SCANNING PROBE MICROSCOPY Inspection of objects or surfaces requiring magnification using a scanning probe microscope. C91965 3321 MICROSCOPIC INSPECTION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91991 3344 SHOCK TESTING Examining a device for problems resulting from transient physical insults such as dropping or shaking the device. C92005 3355 STRESS TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91992 3345 SIMULATED USE TESTING Testing the devices in situations that mimic real life settings but do not involve patients. C92020 3367 USE TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91993 22 SOFTWARE EVALUATION C54028 3291 EVALUATION METHOD FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91994 3346 SOFTWARE STRESS TESTING Tests conducted to evaluate a software application at or beyond the limits of its specified requirements. C91996 3348 SOFTWARE VERIFICATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91995 3347 SOFTWARE VALIDATION Validating that a system or component during or at the end of the development process satisfies specified requirements (the process may include algorithm evaluation). C91993 22 SOFTWARE EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91996 3348 SOFTWARE VERIFICATION A process used to verify that a system or component performs according to the original set of conditions at any point in development. C91993 22 SOFTWARE EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91999 3349 SPECTROSCOPY Testing the device using a spectrometer or spectrograph for the dispersion of visible light (includes electromagnetic, electron, and acoustic spectroscopy). C92023 38 VISUAL INSPECTION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92000 3350 STATIC ANALYSIS The process of analyzing the software code without running it. For example, formal verification, which is proving or disproving the correctness of intended algorithms underlying a system with respect to a certain formal specification or property using formal methods of mathematics e.g. model checking, theorem proving, symbolic verification). C91996 3348 SOFTWARE VERIFICATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92001 3351 STERILITY METHOD VERIFICATION Verifying that the methods used to free a medical device from viable microorganisms such as fungi, bacteria, and viruses were followed. C92002 3352 STERILIZATION PROCESS REVIEW FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92002 3352 STERILIZATION PROCESS REVIEW Performing a review of the records and processes used to render a product free from viable microorganisms. C91978 3331 PROCESS EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92003 3353 STORAGE AND SHIPMENT REVIEW Performing a review of the storage and shipping processes and requirements. C91978 3331 PROCESS EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92004 3354 STRENGTH TESTING Testing the device's ability to resist forces that attempt to break or deform the device. This evaluation includes testing tension such as pull testing. C92005 3355 STRESS TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92005 3355 STRESS TESTING Testing the device for failures caused by applying force per unit area. This test includes durability testing. C91963 26 MECHANICAL EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92007 3356 SURGE PROTECTION TESTING Testing the device's ability to protect itself of other devices against sudden bursts of current or voltage. C91942 3301 IMMUNITY TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92008 3357 SURGE RESPONSE TESTING Testing for a response to a transient electrical current or voltage. C91919 23 ELECTRICAL EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92009 3358 SYSTEM TESTING Tests conducted on a complete, integrated system to evaluate the system's compliance with its specified requirements. C91996 3348 SOFTWARE VERIFICATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92010 3359 TEMPERATURE TESTING Testing the device's characteristics when subjected to temperature change (cycling), and high or low temperatures. C91926 3290 ENVIRONMENT EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92011 3360 TEST FOR HIGH TEMPERATURE CONDITIONS C92013 3362 THERMAL ENERGY EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92012 3361 TEST FOR LOW TEMPERATURE CONDITIONS C92013 3362 THERMAL ENERGY EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92013 3362 THERMAL ENERGY EVALUATION Testing the device for conditions related to extremes of temperature. C54028 3291 EVALUATION METHOD FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92014 3363 THROMBOTIC TESTING Testing the device for characteristics related to forming blood clots along the walls of blood vessels which can cause blockages and affect blood flow through vessels. C91938 3298 HEMATOLOGIC TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92015 3364 TISSUE ENGINEERING EVALUATION Evaluating a device's characteristics that may affect tissues (e.g. bone, cartilage, blood vessels, bladder). C91905 3269 BIOLOGIC EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92018 3365 ULTRASONIC SOUND TESTING Testing the devices response to variations in air pressure for detecting sound with frequencies greater than upper limit of human hearing (> 20 kHz). C91898 3261 ACOUSTIC ENERGY TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92019 3366 UNIT TESTING Testing of individual hardware or software components or groups of related units. C91996 3348 SOFTWARE VERIFICATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92020 3367 USE TESTING Any testing performed that simulates real use situations experienced by users. C91951 20 INTEROPERABILITY EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92021 3368 USER SURVEY Questioning a pre-defined group of users about their practices. C92020 3367 USE TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92022 3369 VIBRATION TESTING Evaluating a device for problems resulting from periodic or random mechanical oscillations which could induce damage. C92005 3355 STRESS TESTING FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92023 38 VISUAL INSPECTION C54028 3291 EVALUATION METHOD FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92024 3370 VOLTAGE FLUCTUATION TESTING Testing the device for its immunity when subjected to positive and negative low amplitude voltage fluctuations. C91919 23 ELECTRICAL EVALUATION FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92025 3371 WEAR TESTING Examining a device for signs of unexpected erosion on its surface or other components or parts. C92005 3355 STRESS TESTING FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92026 3202 AGGLUTINATION The device affects the ability of the blood to clot which may be induced by chemical, mechanical, or thermal properties of the device. C92060 3255 HEMATOLOGIC PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92027 635 ARITHMETIC ERROR The device software performed an incorrect arithmetic operation. C92115 3240 SOFTWARE RUNTIME ERROR FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92028 706 ASSEMBLY PROBLEM A device problem that occurred because the device was assembled or put together incorrectly. C92076 170 MANUFACTURING PROCESS PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92029 3203 BIOCOMPATIBILITY PROBLEM The device causes cellular or tissue responses that elicit an undesirable local or systemic effect in the recipient or beneficiary of that therapy (see ISO 10993). C92030 3204 BIOLOGICAL PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92030 3204 BIOLOGICAL PROBLEM C54029 3249 EVALUATION RESULT FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92031 3205 CARCINOGENIC PROBLEM The device's ability to promote cancer or facilitate its propagation. C92057 3254 GENOTOXIC PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92033 201 CLEANING, DISINFECTING AND STERILIZATION PROBLEM A device problem that occurred during or as the result of the cleaning, disinfecting, or sterilizing process. C92076 170 MANUFACTURING PROCESS PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92034 628 COMMUNICATIONS PROBLEM Devices that do not send or receive adequate signals (this speaks to the interoperability between devices). C92070 3213 INTEROPERABILITY PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92035 3206 COMPLEMENT ACTIVATION The device interferes with an organism's ability to clear pathogens which may be caused by an interaction with chemicals or materials. C92060 3255 HEMATOLOGIC PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92036 3207 COMPONENT MIGRATION A device or a component of a device that has moved from its original location due to external forces (e.g. stent or lead movement). C92079 180 MECHANICAL PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92037 658 CONDUCTED INTERFERENCE A device that experienced electromagnetic interference (EMI) by physical contact with conductors (e.g. wires, resistors, terminals) as opposed to radiated EMI which is caused by induction (without physical contact of the conductors). C92046 197 ELECTROMAGNETIC COMPATIBILITY PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92038 3208 CONFIGURATION ISSUE Device problems due to incorrect version or change control. C92113 104 SOFTWARE PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92054 142 CONTAMINATION BY FOREIGN MATERIAL The undesirable presence of any substance that does not belong either on the device or in an organism and may lead to infection or fever. C92030 3204 BIOLOGICAL PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92044 650 CURRENT LEAKAGE PROBLEM A device that experiences problems related to small currents which may cause electric shock. Leakage current is the current that flows through the protective ground conductor to ground. In the absence of a grounding connection, it is the current that could flow from any conductive part or the surface of non-conductive parts to ground if a conductive path was available (such as a human body). There are always extraneous currents flowing in the safety ground conductor. C92097 3227 POWER SOURCE PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92032 3209 DAMAGE DUE TO CHEMICAL AGENT A device that experienced damage as the result of a chemical agent used during the sterilization process e.g. excessive residual chemical or an incompatible sterilant. C92033 201 CLEANING, DISINFECTING AND STERILIZATION PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92039 663 DATA COMPRESSION ERROR Data was lost or corrupted during the operation of reducing storage space or communication bandwidth. C92042 110 DESIGN ERROR FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92110 3210 DEADLOCK The device software locked up because two or more processes were waiting for each other to finish. C92115 3240 SOFTWARE RUNTIME ERROR FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92040 3211 DEFORMATION PROBLEM Device problems caused by changes in the shape or size of the device or device component due to an applied force. This can be a result of tensile forces, compressive forces, shear, bending, tensile (pulling), or torsion. C92120 3243 STRESS PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92041 135 DEGRADATION PROBLEM Device problems that occur when the device becomes worn, weakened, corroded, or broken down due to processes such as aging, permeation, and corrosion. C92078 174 MATERIALS AND CHEMISTRY PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92042 110 DESIGN ERROR The device or component had faulty (incomplete or incorrect) software design. C92113 104 SOFTWARE PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92043 646 DUST OR DIRT PROBLEM A device that experienced problems due to dust or dirt that has adhered to its surfaces. C92051 331 ENVIRONMENT PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92045 120 ELECTRICAL PROBLEM C54029 3249 EVALUATION RESULT FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92046 197 ELECTROMAGNETIC COMPATIBILITY PROBLEM A device-to-device or device-environment problem resulting from electromagnetic disturbances C54029 3249 EVALUATION RESULT FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92047 648 ELECTROSTATIC DISCHARGE A device that experienced problems due to sudden and momentary bursts of electrical current flowing between 2 objects at different electrical potentials. C92046 197 ELECTROMAGNETIC COMPATIBILITY PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92048 133 END OF LIFE PROBLEM Device problems that occur from its reaching the end of its useful life. C92088 114 OPERATIONAL PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92049 3212 ENDOTOXIN CONTAMINATION The undesirable presence of toxins associated with certain bacteria (e.g. gram negative bacteria). C92054 142 CONTAMINATION BY FOREIGN MATERIAL FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92050 131 ENERGY STORAGE SYSTEM PROBLEM Device problems related to the energy storage system (e.g. the rechargeable battery, charging system, or capacitor) and includes problems such as premature power source depletion and battery explosions. An accumulator is an apparatus by means of which energy can be stored, such as a rechargeable battery or a hydraulic accumulator. Such devices may be electrical, fluidic or mechanical and are sometimes used to convert a small continuous power source into a short surge of energy or vice versa. Other examples of accumulators include capacitors, compulsators, steam accumulator, wave energy machines, pumped-storage hydroelectric plants. C92097 3227 POWER SOURCE PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92051 331 ENVIRONMENT PROBLEM A device problem that occurred due to factors within the environment e.g. dust, dirt, humidity, temperature. C54029 3249 EVALUATION RESULT FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C54029 3249 EVALUATION RESULT C62596 FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92052 3250 FAILURE TO CALIBRATE A device that cannot calibrate (establish the relationship between a measuring device and the units of measure) to ensure accurate readings. C92088 114 OPERATIONAL PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92053 3251 FATIGUE PROBLEM Device problems due to the weakening or breakdown of its material when subjected to stress or a series of repeated stresses. C92120 3243 STRESS PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92055 3252 FRACTURE PROBLEM Device problems caused by the separation of a component, object, or material into two or more pieces including shear. C92120 3243 STRESS PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92056 3253 FRICTION PROBLEM A device problem caused by its surface coming in contact with another surface or fluid. C92079 180 MECHANICAL PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92057 3254 GENOTOXIC PROBLEM The device's ability to cause damage to genetic material (e.g., leading malignant tumors). (See ISO 10993) C92030 3204 BIOLOGICAL PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92058 323 GRADIENT INDUCED FIELD PROBLEM Device problems that result from the gradient induced fields generated during radiologic procedures e.g. magnetic resonance imaging. C92102 3230 RADIOGRAPHIC PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92059 211 HARDWARE TIMING PROBLEM A problem that results from improper sequencing or activation of electronic components. C92045 120 ELECTRICAL PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92060 3255 HEMATOLOGIC PROBLEM The device affects or impacts the blood or its components. (See ISO 10993) C92030 3204 BIOLOGICAL PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92062 3256 IMAGE ARTIFACT The unacceptable distortion of an image due to signal loss that may occur during a radiologic procedure such as magnetic resonance imaging. C92102 3230 RADIOGRAPHIC PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92063 3257 IMPEDANCE PROBLEM A device that experienced problems due to insufficient or excessive resistance to AC current flow either by the device or circuit. C92045 120 ELECTRICAL PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92064 3258 IMPROPER COMPOSITION/CONCENTRATION Device problems associated with the improper combination of materials or elements present in the device (e.g., improper composition of the materials of a capacitor). C92065 202 IMPROPER MATERIAL FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92061 332 IMPROPER HUMIDITY A device that malfunctions as the result of exposure to undesirable levels of humidity C92051 331 ENVIRONMENT PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92065 202 IMPROPER MATERIAL Device problems that occur due to the presence of a material that should not be present or part of the device. C92078 174 MATERIALS AND CHEMISTRY PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92133 3259 IMPROPER PHYSICAL STRUCTURE A device problem related to the incorrect or inadequate arrangement of the parts, components, elements, or materials. C92065 202 IMPROPER MATERIAL FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92134 651 IMPROPER TEMPERATURE A device that malfunctions as the result of exposure to the temperatures that are outside of those in the device's specifications. C92051 331 ENVIRONMENT PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92135 3260 INADEQUATE IMMUNITY A device that lacks adequate immunity or capabilities to resist electromagnetic interference (EMI). C92046 197 ELECTROMAGNETIC COMPATIBILITY PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92137 154 INADEQUATE INSTRUCTIONS FOR USE Insufficient information on the labels or in the manuals related to a device's instructions for use e.g. steps that are difficult to follow or that are missing. C92071 150 LABELING PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92136 156 INADEQUATE LABELING CONTENT Invalid, incorrect, or inappropriate information on the labels (not including instructions for use) e.g. mislabeled contents or device labeling characteristics or package contents. C92071 150 LABELING PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92138 195 INAPPROPRIATE OR INSUFFICIENT STERILIZATION Inadequate sterilization of a device possibly resulting in the presence of microorganisms or other contaminants on the device. C92033 201 CLEANING, DISINFECTING AND STERILIZATION PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92066 102 INCOMPATIBLE COMPONENT A device that malfunctions due to a component(s) that does not operate correctly and according to the device's specifications. C92070 3213 INTEROPERABILITY PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92139 203 INCOMPATIBLE MATERIAL Device problems related to materials that can co-exist simultaneously as part of the device. C92078 174 MATERIALS AND CHEMISTRY PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92140 3199 INCOMPLETE DEVICE RETURNED The device that was returned was not complete and/or is missing parts or components. C54029 3249 EVALUATION RESULT FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92142 618 INCORRECT ALGORITHM The device software was found to implement an incorrect sequence of steps for a specific computation. C92042 110 DESIGN ERROR FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92141 3200 INCORRECT DATA DEFINITION The device software was found to contain errors in specifying or manipulating data items. C92042 110 DESIGN ERROR FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92067 3201 INSTALLATION PROBLEM A device that malfunctions because it was incorrectly installed, set-up, or configured (e.g., misconfiguration of an automatic defibrillator to semi-automatic leading to failure) C92076 170 MANUFACTURING PROCESS PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92068 144 INSULATION PROBLEM A device that has inadequate or incorrect insulation material. C92045 120 ELECTRICAL PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92069 113 INTERFACE DESIGN ERROR The device software was found to contain errors in the user interface (including usability problems) or the interfaces with other systems. C92042 110 DESIGN ERROR FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92070 3213 INTEROPERABILITY PROBLEM A problem with the mechanical, electrical, or communication interface between two or more separate devices or components. C54029 3249 EVALUATION RESULT FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92071 150 LABELING PROBLEM Insufficient, inadequate, or incorrect information provided on a device's label or documentation regarding e.g. as the intended use, directions for use, and characteristics of the device. C54029 3249 EVALUATION RESULT FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92112 3214 LIVELOCK The device software failed because two or more processes compete with each other such that the program does not perform as intended. C92115 3240 SOFTWARE RUNTIME ERROR FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92072 610 LOSS OF POWER A device that experienced problems due to a loss in the power supply. C92097 3227 POWER SOURCE PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92073 145 LUBRICATION PROBLEM A device problem that occurred because of the presence of either too much or too little lubricant where required (e.g., connectors, leading to failure mechanisms such as corrosion). C92079 180 MECHANICAL PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92074 3215 MAGNETICALLY-INDUCED TORQUE Problems due to excessive torque created by the application of magnetic fields. C92102 3230 RADIOGRAPHIC PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92075 115 MAINTENANCE PROBLEM A device malfunction or problem that occurs because the device was not properly maintained according to the instructions (e.g., maintenance may be performed by user facility, distributor, or service provider). C92076 170 MANUFACTURING PROCESS PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92076 170 MANUFACTURING PROCESS PROBLEM Problems with a device that can be traced back to a problem in the manufacturing and/or production process. C54029 3249 EVALUATION RESULT FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92077 3216 MATERIAL OR MATERIAL LEACHATE PYROGENIC PROBLEM The undesirable presence of pyrogens or fever-producing organisms caused by materials that permeate through the device. C92054 142 CONTAMINATION BY FOREIGN MATERIAL FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92078 174 MATERIALS AND CHEMISTRY PROBLEM Device malfunctions that arise from problems with its components or materials or how its materials or components react to other elements either within the device or within the environment. C54029 3249 EVALUATION RESULT FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92079 180 MECHANICAL PROBLEM Device problems that result from internal or external forces including fluids, other objects, or environmental or physiologic influences. C54029 3249 EVALUATION RESULT FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92080 3217 MECHANICAL SHOCK PROBLEM Device problems caused by the sudden violent blow or collision to the whole device (e.g. by dropping). C92120 3243 STRESS PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92081 3218 MICROBIAL CONTAMINATION The undesirable presence of microorganisms or microbes such as bacteria and fungi (yeasts and molds). C92054 142 CONTAMINATION BY FOREIGN MATERIAL FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92121 3219 MOLECULAR STRUCTURE PROBLEM Device problems related to the presence of an inappropriate molecular geometry somewhere in the device (i.e., the spatial arrangement of atoms in a molecule and the chemical bonds that hold the atoms together). C92065 202 IMPROPER MATERIAL FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92082 3220 MUTAGENIC PROBLEM The device's ability to change genetic information (usually DNA) of an organism and thus increasing the frequency of mutations. C92057 3254 GENOTOXIC PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92083 213 NO FAILURE DETECTED The device either functioned as designed or a failure was not found. C54029 3249 EVALUATION RESULT FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92084 3221 NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED For use when no methods were performed and therefore no results will be obtained. C54029 3249 EVALUATION RESULT FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92085 3222 NON-FUNCTIONAL DEFECT The device software contained software errors that did not impact its operation. C92042 110 DESIGN ERROR FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92086 3223 NON-TERMINATING CODE The device software failed to provide a safe exit from a repeating code segment. C92115 3240 SOFTWARE RUNTIME ERROR FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92087 122 OPEN CIRCUIT A device with an electrical circuit that does not conduct current because a switch is open, a wire is broken, etc. C92045 120 ELECTRICAL PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92088 114 OPERATIONAL PROBLEM Device problems that occur during the performance, use, or functioning of the device. C54029 3249 EVALUATION RESULT FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92089 3224 OPTICAL PROBLEM C54029 3249 EVALUATION RESULT FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92090 196 OPTICAL TRANSMISSION PROBLEM A problem with the device's ability to pass light energy. C92089 3224 OPTICAL PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92091 3225 OUT-OF-BOUNDS ERROR The device software attempted to write data outside the allowed memory location. C92115 3240 SOFTWARE RUNTIME ERROR FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92092 160 PACKAGE INSERT PROBLEM Device packaging that is missing the insert or that contains an incorrect or inadequate insert (e.g. an insert with either the incorrect information or insufficient information). C92094 111 PACKAGING PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92093 171 PACKAGING COMPROMISED Device packaging that has been opened purposefully or inadvertently thus exposing the device to the outside environment and rendering it unsterile or unclean (e.g. a broken seal or ripped or torn packaging). C92094 111 PACKAGING PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92094 111 PACKAGING PROBLEM Reports related to the outer, protective wrapping of a device (e.g. a broken seal or ripping (compromised), lack of correct contents). C92076 170 MANUFACTURING PROCESS PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92095 3226 PLATELET ACTIVATION PROBLEM A device that affects the body's ability to activate platelets which are essential to stop bleeding and repair the tissue. Platelets also play a key role in the development of acute coronary syndromes and contribute to cerebrovascular events. C92060 3255 HEMATOLOGIC PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92096 659 POWER FLUCTUATION The device or component failed due to fluctuations within the power supply (e.g. transient power, power spike, power dip, or power sequencing). C92097 3227 POWER SOURCE PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92097 3227 POWER SOURCE PROBLEM Problems that are related to the device that provides power. C92045 120 ELECTRICAL PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92098 3228 PROTECTIVE SYSTEM FAILURE A device that fails when the system designed to ensure its safe operation fails. C92045 120 ELECTRICAL PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92099 143 QUALITY CONTROL PROBLEM Device problems that result from the failure to maintain or establish techniques for controlling and verifying the product specifications identified by the manufacturer. C92076 170 MANUFACTURING PROCESS PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92100 3229 RADIOFREQUENCY INDUCED OVERHEATING An unacceptable or unexpected RF-induced temperature rise in the vicinity of a medical device or body part (usually caused by a closed current loop). C92102 3230 RADIOGRAPHIC PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92101 611 RADIOFREQUENCY INTERFERENCE (RFI) A device that experienced problems due to radiofrequency interference. RFI is a disturbance that affects an electrical circuit due to either electromagnetic conduction or electromagnetic radiation emitted from an external source. C92046 197 ELECTROMAGNETIC COMPATIBILITY PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92102 3230 RADIOGRAPHIC PROBLEM Problems that occur with devices used for radiographic or imaging procedures e.g. CT scanners, magnetic resonance imaging, etc. C92045 120 ELECTRICAL PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92103 3231 REACTIVITY PROBLEM A device problem related to how the materials react inappropriately (e.g. over-react or under-react). C92078 174 MATERIALS AND CHEMISTRY PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92104 3232 REPRODUCTIVE TOXICITY PROBLEM The device or component affects reproductive function, embryo development (teratogenicity), and prenatal and early postnatal development. (ISO 10993 part 3) C92030 3204 BIOLOGICAL PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92143 3233 RESULTS PENDING COMPLETION OF EVALUATION For use when the evaluation is still in progress. C54029 3249 EVALUATION RESULT FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92144 3234 REUSED DEVICE NOT CLEANED A device that has been used more than once without being cleaned according to the device's cleaning instructions. C92033 201 CLEANING, DISINFECTING AND STERILIZATION PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92105 3235 RUNTIME MEMORY ACCESS ERROR The device software attempted to access an illegal or corrupted memory location. C92115 3240 SOFTWARE RUNTIME ERROR FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92106 192 SHELF LIFE EXCEEDED A device that has exceeded the period of time recommended by the manufacturer for storing the device without a degradation in quality. C92088 114 OPERATIONAL PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92107 3236 SHIPPING PROBLEM Device problems traced back to how the device was shipped (some examples may include the temperature of the shipping compartment or the method of transportation). C92076 170 MANUFACTURING PROCESS PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92108 121 SHORT CIRCUIT A device experiencing problems due to an unintentionally low-resistance connection between two points in an electric circuit, resulting in either excessive current flow that often causes damage or in a new shorter circuit that draws current away from the original pathways and components. C92045 120 ELECTRICAL PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92109 3237 SIGNAL LOSS Problems with a device due the loss or weakening of a signal or signals. C92045 120 ELECTRICAL PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92111 3238 SOFTWARE INSTALLATION PROBLEM The device software was not installed as per the specifications or failed to properly install. C92113 104 SOFTWARE PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92113 104 SOFTWARE PROBLEM C54029 3249 EVALUATION RESULT FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92114 3239 SOFTWARE REQUIREMENT ERROR The software requirements for the device are either incomplete, inadequate, or in conflict. C92113 104 SOFTWARE PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92115 3240 SOFTWARE RUNTIME ERROR The device software failed during operation as a result of a coding error. C92113 104 SOFTWARE PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92116 3241 SOFTWARE SECURITY VULNERABILITY The device software failed to provide adequate authorization, access control, and accountability features. C92113 104 SOFTWARE PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92117 634 SOFTWARE TIMING PROBLEM A device problem that results from the incorrect sequencing or activation of software modules. C92042 110 DESIGN ERROR FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92118 3242 STIFFNESS PROBLEM A device problem that occurred when its material is either too flexible/pliable or inflexible/rigid when in contact by an applied force. C92079 180 MECHANICAL PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92119 193 STORAGE PROBLEM Device problems that result from storing the device in an uncontrolled or improper environment (e.g., moisture sensitive devices stored in a humid environment). C92076 170 MANUFACTURING PROCESS PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92120 3243 STRESS PROBLEM Device problems caused by either excessive or inadequate physical force exerted on it by another object resulting in problems e.g. wear, bending, deformation, fracture, fatigue. C92079 180 MECHANICAL PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92122 642 THERMAL PROBLEM Device problems related to the temperature of the component, device or use environment. C54029 3249 EVALUATION RESULT FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92123 3244 THROMBOSIS ACTIVATION PROBLEM The device or component caused the formation of a stationary blood clot along the walls of a blood vessel resulting in an obstruction. The obstruction can occur by several means e.g. blood clotting problems (coagulation), clots from other areas of the body (emboli), or caused by device materials or reactions to drugs or the removal of drugs. C92060 3255 HEMATOLOGIC PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92124 176 TOLERANCE STACK-UP Device problems that result from a combination of specification variances of the components. C92088 114 OPERATIONAL PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92125 3245 TYPE MISMATCH The device software assigned one type of value into a variable of another type. C92115 3240 SOFTWARE RUNTIME ERROR FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92126 637 UNHANDLED INTERRUPT OR EXCEPTION The device software did not correctly address abnormal execution of the code. C92115 3240 SOFTWARE RUNTIME ERROR FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92127 3246 UNREACHABLE CODE The device software contained code that could never be executed under any circumstance. C92115 3240 SOFTWARE RUNTIME ERROR FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92128 3247 UNUSED DEVICE RETURNED IN STERILE PACKAGING An unused device that has been returned in packaging that remains intact. C92094 111 PACKAGING PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92129 649 VIBRATION PROBLEM Device problems caused by the constant rhythmic motion of the device, a device's component, or something in the environment to which the device is exposed. C92120 3243 STRESS PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92130 140 WEAR PROBLEM Device problems due to the premature or expected erosion of its material by use, deterioration, or change. C92120 3243 STRESS PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92131 608 WIRED COMMUNICATION PROBLEM Communications problems between devices within a wired system. C92034 628 COMMUNICATIONS PROBLEM FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92132 3248 WIRELESS COMMUNICATION PROBLEM Communications problems between devices within a wireless system. C92034 628 COMMUNICATIONS PROBLEM FDA C54451 Medical Device Problem Codes FDA CDRH C63281 2288 ABORTED CHARGE CHARGE, ABORTED Issue associated with the premature ending of the charging process (e.g. of a battery or other charge storage device). C63026 2892 CHARGING ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63036 1004 ACCESSORY INCOMPATIBLE ACCESSORIES, INCOMPATIBLE C63020 2897 COMPONENT OR ACCESSORY INCOMPATIBILITY FDA C54451 Medical Device Problem Codes FDA CDRH C63311 1008 AIR LEAK AIR LEAK(S) C63127 2946 GAS LEAK FDA C54451 Medical Device Problem Codes FDA CDRH C63309 1022 ALARM NOT VISIBLE C63112 2951 IMPROPER ALARM FDA C54451 Medical Device Problem Codes FDA CDRH C63308 2877 AMBIENT NOISE ISSUE Issue associated with any undesired acoustic energy or vibration that tends to interfere with the operation of the device. C63209 2929 ENVIRONMENTAL CONTROL OR UTILITY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63307 2878 AMBIENT TEMPERATURE ISSUE Issue associated with compromised device-performance at the ambient room temperature. C63209 2929 ENVIRONMENTAL CONTROL OR UTILITY 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 2880 APPLICATION PROGRAM ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C64349 2879 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 C63305 2880 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 C63304 2881 APPLICATION PROGRAM VERSION OR UPGRADE PROBLEM C63305 2880 APPLICATION PROGRAM ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63042 2882 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 3025 UNAUTHORIZED ACCESS TO COMPUTER SYSTEM FDA C54451 Medical Device Problem Codes FDA CDRH C63301 2583 ARCING Issue associated with electrical current flowing through a gap between two conductive surfaces, typically resulting in a visible flash of light. C63005 2928 ELECTRONIC PROPERTY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63303 2289 ARCING AT ELECTRODES C63301 2583 ARCING FDA C54451 Medical Device Problem Codes FDA CDRH C63302 1032 ARCING AT PADDLES C63301 2583 ARCING FDA C54451 Medical Device Problem Codes FDA CDRH C63300 1036 ARTIFACT Issue associated with impurities or interference in a signal or image (e.g. ECG artifact). C62829 2456 INCORRECT OR INADEQUATE TEST RESULTS FDA C54451 Medical Device Problem Codes FDA CDRH C63299 2883 ASPIRATION ISSUE C62833 2170 SUCTION ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63297 2303 BACTERIAL CONTAMINATION OF DEVICE BACTERIAL CONTAMINATION|CONTAMINATION, BACTERIAL C63017 2908 DEVICE CONTAMINATION WITH BIOLOGICAL MATERIAL FDA C54451 Medical Device Problem Codes FDA CDRH C64334 2884 BATTERY IMPEDANCE ISSUE C63030 2885 BATTERY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63030 2885 BATTERY ISSUE C63025 3010 POWER SOURCE ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63296 1059 BENT BEND MATERIAL|BENT MATERIAL C62962 2981 MATERIAL TWISTED FDA C54451 Medical Device Problem Codes FDA CDRH C63294 2886 BIOCOMPATIBILITY ISSUE C62982 2910 DEVICE INGREDIENT OR REAGENT 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 C63292 2887 BIOLOGICAL ENVIRONMENTAL FACTOR C63209 2929 ENVIRONMENTAL CONTROL OR UTILITY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63290 1064 BLEED BACK C63110 2954 IMPROPER FLOW OR INFUSION 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 C63288 2888 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 2900 CONNECTION ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62973 1069 BREAK DEVICE BREAKAGE|MATERIAL BREAK Issue associated with undesired damage or breakage of those materials used in device construction. C62968 2978 MATERIAL INTEGRITY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63287 2889 BUCKLED MATERIAL Issue associated with an undesired bulge, bend, bow, kink, or wavy condition observed in the device material resulting from compressive stresses. C62968 2978 MATERIAL INTEGRITY ISSUE 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 device or its components. C62922 3022 TEMPERATURE ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62972 1074 BURST MATERIAL BURST Issue associated with the pressure inside a vessel or container rising to such a degree that the container ruptures. C62968 2978 MATERIAL INTEGRITY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63285 1077 CALCIFIED CALCIFICATION|CALCIFIED MATERIAL Issue associated with build-up of calcium salts on the device or its components. C62970 1153 DEGRADED 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 C63028 2890 CALIBRATION ISSUE Issue associated with the operation of the device, related to its accuracy, and associated with the calibration of the device. C62954 2914 DEVICE OPERATIONAL 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 C63027 2891 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 C63282 1027 CHANGES IN AMBIENT TEMPERATURE IN DEVICE ENVIRONMENT AMBIENT TEMPERATURE, CHANGES IN C63307 2878 AMBIENT TEMPERATURE ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63026 2892 CHARGING ISSUE Issue associated with the inability of device and/or device components to successfully charge an electrical source. C63025 3010 POWER SOURCE 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 C62945 2893 CHEMICAL ISSUE Issue associated with any deviations from device documented performance specifications relating to any chemical characterization, i.e., element, compound, or mixture. C62937 3008 PHYSICAL PROPERTY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63278 2894 CHEMICAL SPILLAGE Issue associated with unintentional pouring out or releasing of chemical substances. C62945 2893 CHEMICAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63277 1089 CIRCUIT FAILURE Issue associated with a failure of the internal network paths or electrical circuitry (i.e. electrical components, circuit boards, wiring). C63005 2928 ELECTRONIC PROPERTY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63275 1095 CLUMPING IN DEVICE OR DEVICE INGREDIENT CLUMPING Issue associated with the aggregation of particles into irregular masses. C62845 3021 SEDIMENT, PRECIPITATE OR DEPOSIT IN DEVICE OR DEVICE INGREDIENT 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 3021 SEDIMENT, PRECIPITATE OR DEPOSIT IN DEVICE OR DEVICE INGREDIENT FDA C54451 Medical Device Problem Codes FDA CDRH C63273 1098 COILED C62962 2981 MATERIAL TWISTED 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 C63271 2896 COMMUNICATION OR TRANSMISSION ISSUE Issue associated with the device sending or receiving signals or data. This includes transmission among internal components of the device and other external devices to which the device is intended to communicate. C62937 3008 PHYSICAL PROPERTY 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 2923 DISLODGED OR DISLOCATED FDA C54451 Medical Device Problem Codes FDA CDRH C63022 1108 COMPONENT INCOMPATIBLE COMPONENT(S), INCOMPATIBLE C63020 2897 COMPONENT OR ACCESSORY INCOMPATIBILITY 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 2975 MANUFACTURING OR SHIPPING ISSUE ASSOCIATED WITH DEVICE FDA C54451 Medical Device Problem Codes FDA CDRH C63020 2897 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 2960 INCOMPATIBILITY PROBLEM FDA C54451 Medical Device Problem Codes FDA CDRH C63270 2898 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 C63269 1112 COMPUTER SOFTWARE ISSUE COMPUTER SOFTWARE ERROR Issue associated with written programs, codes, and/or software system that affects device performance or communication with another device. C62954 2914 DEVICE OPERATIONAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C64348 2899 COMPUTER SYSTEM SECURITY ISSUE C63269 1112 COMPUTER SOFTWARE ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62952 2900 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 liquid, gas, electricity or data. C62954 2914 DEVICE OPERATIONAL ISSUE 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 2895 DISINFECTION OR STERILIZATION ISSUE AT USER LOCATION FDA C54451 Medical Device Problem Codes FDA CDRH C63266 2901 CONTAMINATION OF DEVICE INGREDIENT OR REAGENT C63018 1120 CONTAMINATION DURING USE 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 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 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 2978 MATERIAL INTEGRITY ISSUE 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 3021 SEDIMENT, PRECIPITATE OR DEPOSIT IN DEVICE OR DEVICE INGREDIENT FDA C54451 Medical Device Problem Codes FDA CDRH C63260 2454 CUT IN MATERIAL CUT(S)|CUT C62967 2205 MATERIAL PERFORATION FDA C54451 Medical Device Problem Codes FDA CDRH C63258 2902 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 C91397 3196 DATA ISSUE Event in which data (charting, orders, results) is not correctly stored, transferred, updated, or displayed. Incorrect transfer, storage, display or updating of data. C63305 2880 APPLICATION PROGRAM ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C67508 2582 DATE-RELATED SOFTWARE ISSUE 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 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 2900 CONNECTION ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63255 1490 DECREASE IN PRESSURE PRESSURE, DECREASE IN C62934 3012 PRESSURE ISSUE 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 C63252 1500 DECREASED PUMP SPEED PUMP SPEED, DECREASED C62860 3016 PUMPING ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63253 2534 DECREASED SENSITIVITY SENSITIVITY, DECREASED|UNDERSENSING Issue with the device being less sensitive to an input than intended or expected. C63061 2293 INVALID SENSING FDA C54451 Medical Device Problem Codes FDA CDRH C63251 1014 DEFECTIVE ALARM ALARM, DEFECTIVE C63112 2951 IMPROPER ALARM 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 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 2975 MANUFACTURING OR SHIPPING ISSUE ASSOCIATED WITH DEVICE 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 its contents. C63075 2964 INFUSION OR FLOW ISSUE 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 2978 MATERIAL INTEGRITY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C50433 2904 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 C63247 1011 DELAYED ALARM ALARM, DELAYED C63112 2951 IMPROPER ALARM FDA C54451 Medical Device Problem Codes FDA CDRH C63280 2586 DELAYED CHARGE TIME CHARGE TIMES, DELAYED Issue associated with an unexpected amount of time required to charge the device as required (for example, a delay in starting charging or a longer than expected charge time). C63026 2892 CHARGING ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63014 1421 DELIVERED AS UNSTERILE PRODUCT NONSTERILITY Issue associated with the device being received in such a manner to indicate that its sterility has been compromised (e.g. sterile packaging breached, visible contaminate present). C63019 2969 ITEM CONTAMINATED DURING MANUFACTURING OR SHIPPING FDA C54451 Medical Device Problem Codes FDA CDRH C63246 2905 DELIVERY SYSTEM FAILURE C62961 1384 MECHANICAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63245 2526 DENT IN MATERIAL DENT C63248 2976 MATERIAL DEFORMATION FDA C54451 Medical Device Problem Codes FDA CDRH C63013 2906 DEPLOYMENT ISSUE Issue associated with any deviations from device documented performance specifications relating to the sequence of events for activation and positioning of the device or one of its components into a specific body location. C62954 2914 DEVICE OPERATIONAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63243 1104 DETACHMENT OF DEVICE COMPONENT COMPONENT(S), DETACHMENT OF|DEVICE COMPONENT DETACHED Issue associated with the unintentional separation of the device and/or its components from something to which it is connected or attached. C63242 2907 DETACHMENT OF DEVICE OR DEVICE COMPONENT FDA C54451 Medical Device Problem Codes FDA CDRH C63242 2907 DETACHMENT OF DEVICE OR DEVICE COMPONENT DEVICE OR DEVICE COMPONENT DETACHED Issue associated with the unintentional separation of the device and/or its components from something to which it is connected or attached. C62961 1384 MECHANICAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63037 1387 DEVICE ABRASION FROM INSTRUMENT OR ANOTHER OBJECT ABRASION FROM INSTRUMENT/OBJECT C62846 3020 SCRATCHED MATERIAL FDA C54451 Medical Device Problem Codes FDA CDRH C63033 1012 DEVICE ALARM SYSTEM ISSUE ALARM FAILURE|ALARM, FAILURE TO 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 3015 PROTECTIVE MEASURE ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63099 1091 DEVICE CLEANING ISSUE 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 2895 DISINFECTION OR STERILIZATION ISSUE AT USER LOCATION 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 C63017 2908 DEVICE CONTAMINATION WITH BIOLOGICAL MATERIAL C63018 1120 CONTAMINATION DURING USE FDA C54451 Medical Device Problem Codes FDA CDRH C63016 2317 DEVICE CONTAMINATION WITH BLOOD OR BLOOD PRODUCT BLOOD CONTAMINATED DEVICE C63017 2908 DEVICE CONTAMINATION WITH BIOLOGICAL MATERIAL FDA C54451 Medical Device Problem Codes FDA CDRH C63015 2284 DEVICE DAMAGED PRIOR TO USE DAMAGE, INTERNAL/EXTERNAL|DAMAGED ITEM|ITEM DAMAGED PRIOR TO USE C63041 2975 MANUFACTURING OR SHIPPING ISSUE ASSOCIATED WITH DEVICE FDA C54451 Medical Device Problem Codes FDA CDRH C79146 3134 DEVICE DIFFICULT TO MAINTAIN C76121 2949 HUMAN-DEVICE INTERFACE ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63010 1487 DEVICE DIFFICULT TO SETUP OR 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. C76121 2949 HUMAN-DEVICE INTERFACE ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63008 2909 DEVICE DISINFECTION OR STERILIZATION ISSUE C63099 1091 DEVICE CLEANING ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63205 2591 DEVICE DISPLAYS ERROR MESSAGE Issue associated with a device prompting user with an error message in order to indicate a device problem. C62955 2913 DEVICE OPERATES DIFFERENTLY THAN EXPECTED FDA C54451 Medical Device Problem Codes FDA CDRH C63004 1425 DEVICE EMITS ODOR C62945 2893 CHEMICAL 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. C63209 2929 ENVIRONMENTAL CONTROL OR UTILITY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C95879 3265 DEVICE HANDLING ISSUE User handling not in accordance with specification. C63318 1670 USE OF DEVICE ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62982 2910 DEVICE INGREDIENT OR REAGENT ISSUE C62945 2893 CHEMICAL 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 C62996 2379 DEVICE ISSUE DEVICE FAILURE|MALFUNCTION C62596 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 2935 FACILITIES ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62976 2911 DEVICE MARKINGS ISSUE Issue associated with the 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. Issue can include but is not limited to this material being unclear, missing worn out, incorrect or inaccurate. C63041 2975 MANUFACTURING OR SHIPPING ISSUE ASSOCIATED WITH DEVICE FDA C54451 Medical Device Problem Codes FDA CDRH C62957 2912 DEVICE MISASSEMBLED DURING MANUFACTURING OR SHIPPING C63041 2975 MANUFACTURING OR SHIPPING ISSUE ASSOCIATED WITH DEVICE FDA C54451 Medical Device Problem Codes FDA CDRH C62955 2913 DEVICE OPERATES DIFFERENTLY THAN EXPECTED Issue associated with any deviations from expected performance while operating and using the device. C62954 2914 DEVICE OPERATIONAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62954 2914 DEVICE OPERATIONAL ISSUE Issue associated with any deviations from specifications relating to device operations (e.g. 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 C62951 2915 DEVICE OR DEVICE COMPONENT DAMAGED BY ANOTHER DEVICE Issue associated with one device and/or device component causing harm to another device and/or component. C62961 1384 MECHANICAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63038 2590 DEVICE OR DEVICE FRAGMENTS LOCATION UNKNOWN DEVICE/DEVICE FRAGMENTS, UNKNOWN LOCATION OF C62950 2923 DISLODGED OR DISLOCATED FDA C54451 Medical Device Problem Codes FDA CDRH C63240 2916 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 3007 PACKAGING ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62931 1525 DEVICE REMAINS ACTIVATED Issue associated with the device continuing to be in an active state after deactivation was requested. C62988 2939 FAILURE TO SHUT OFF FDA C54451 Medical Device Problem Codes FDA CDRH C63107 2309 DEVICE RINSING ISSUE RINSING, IMPROPER C63099 1091 DEVICE CLEANING ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63238 2917 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 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 2913 DEVICE OPERATES DIFFERENTLY THAN EXPECTED FDA C54451 Medical Device Problem Codes FDA CDRH C73118 2918 DEVICE UNSAFE TO USE IN ENVIRONMENT C63209 2929 ENVIRONMENTAL CONTROL OR UTILITY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63236 2919 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 2960 INCOMPATIBILITY PROBLEM 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 C63235 2920 DIFFICULT TO ADVANCE Issue associated with difficulty moving the device or its components to an intended location (e.g. difficulty in advancing guidewire). C63034 3009 POSITIONING ISSUE 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 2906 DEPLOYMENT ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63317 1251 DIFFICULT TO FLUSH FLUSH, DIFFICULT TO C62896 1423 OCCLUSION WITHIN DEVICE 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. C62923 2506 STRUCTURAL PROBLEM FDA C54451 Medical Device Problem Codes FDA CDRH C63233 1316 DIFFICULT TO INSERT INSERTION DIFFICULTIES Issue associated with problems introducing or inserting the device, even if the user is operating the device in accordance with the instructions for use or labeling. C63034 3009 POSITIONING 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 C63012 2921 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. C62923 2506 STRUCTURAL PROBLEM FDA C54451 Medical Device Problem Codes FDA CDRH C63231 2922 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 3007 PACKAGING ISSUE 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. C63034 3009 POSITIONING ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C64339 1496 DIFFICULT TO PROGRAM OR CALIBRATE PROGRAM, DIFFICULT TO Issue associated with the user's ability to cause device settings or actions to change to the state desired by the user. C76121 2949 HUMAN-DEVICE INTERFACE ISSUE 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. C63034 3009 POSITIONING ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63225 1168 DISASSEMBLY C63242 2907 DETACHMENT OF DEVICE OR DEVICE COMPONENT 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 2900 CONNECTION ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63276 2895 DISINFECTION OR STERILIZATION ISSUE AT USER LOCATION 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. This issue is restricted to happening at the location where the device is used as opposed to during manufacturer or shipping. C62808 2935 FACILITIES ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62950 2923 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 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 C63220 1189 DOSE CALCULATION ERROR DUE TO SOFTWARE PROBLEM DOSE CALCULATION ERROR C63081 1495 INCORRECT SOFTWARE PROGRAMMING CALCULATIONS FDA C54451 Medical Device Problem Codes FDA CDRH C63219 2407 DULL C62948 1506 PRODUCT QUALITY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63007 1198 ELECTRICAL ISSUE DEVICE ELECTRICAL ISSUE|ELECTRICAL FAILURE Issue associated with a failure of the electrical circuitry or components of the device. C62954 2914 DEVICE OPERATIONAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63218 2924 ELECTRICAL OVERSTRESS Issue associated with an electrical activity that exceeded the specified threshold limit of the internal integrated circuitry. C63005 2928 ELECTRONIC PROPERTY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63217 2925 ELECTRICAL POWER PROBLEM Issue associated with the quality of the facility-supplied power. C63209 2929 ENVIRONMENTAL CONTROL OR UTILITY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63216 2926 ELECTRICAL SHORTING C63277 1089 CIRCUIT FAILURE FDA C54451 Medical Device Problem Codes FDA CDRH C63215 2927 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 2928 ELECTRONIC PROPERTY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63214 1194 ELECTRO-MAGNETIC INTERFERENCE (EMI) Issue associated with a measure of electromagnetic radiation from equipment. C63215 2927 ELECTROMAGNETIC COMPATIBILITY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63005 2928 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 3008 PHYSICAL PROPERTY ISSUE 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 2927 ELECTROMAGNETIC COMPATIBILITY 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 2925 ELECTRICAL POWER PROBLEM 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 C63000 1210 ENERGY SPECTRUM INCORRECT C63002 1431 OUTPUT ENERGY INCORRECT 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, tissue, or other devices or device components. C63034 3009 POSITIONING ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63209 2929 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 2935 FACILITIES ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C72674 2930 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 2929 ENVIRONMENTAL CONTROL OR UTILITY 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 C63204 2931 ESCAPE C62950 2923 DISLODGED OR DISLOCATED FDA C54451 Medical Device Problem Codes FDA CDRH C62882 1311 EXCESS FLOW OR OVERINFUSION OVERDELIVERY|OVERINFUSION C63075 2964 INFUSION OR FLOW ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63202 2932 EXCESSIVE COOLING Issue associated with the device or its components producing temperatures that are lower than specified. C62922 3022 TEMPERATURE 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 C50554 2933 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 2934 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 C62808 2935 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 C63199 1222 FAIL-SAFE DESIGN FAILURE Issue associated with safety features malfunctioning in such a way that results in harm to the patient or device operator. C62997 2936 FAIL-SAFE MECHANISM ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62997 2936 FAIL-SAFE MECHANISM ISSUE C62932 3015 PROTECTIVE MEASURE ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62989 2937 FAILURE OF DEVICE TO SELF-TEST Issue associated with the device failing to perform an internal self-diagnostic process to ensure normal operation during or prior to use. C62997 2936 FAIL-SAFE MECHANISM ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63032 1031 FAILURE TO ADHERE OR BOND Issue associated with difficulties in attaching a device to another object including another device or device component or to a patient body part. C62955 2913 DEVICE OPERATES DIFFERENTLY THAN EXPECTED FDA C54451 Medical Device Problem Codes FDA CDRH C63198 2524 FAILURE TO ADVANCE ADVANCE, FAILURE TO Issue associated with failure to move the device or its components to an intended location. C63034 3009 POSITIONING ISSUE 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 2984 MECHANICS ALTERED 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 C62995 2938 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 3015 PROTECTIVE MEASURE ISSUE 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 2902 DATA BACK-UP PROBLEM FDA C54451 Medical Device Problem Codes FDA CDRH C62994 2440 FAILURE TO CALIBRATE CALIBRATE, FAILURE TO Issue associated with the failure of the device to perform a self-calibration procedure or process designed to assure the accuracy and proper performance of the device. C63028 2890 CALIBRATION 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 2891 CAPTURING ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63193 1085 FAILURE TO CHARGE CHARGE, FAILURE TO Issue associated with inability to initiate the appropriate charging process (e.g. of a battery or other charge storage device). C63026 2892 CHARGING ISSUE 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 C63190 1540 FAILURE TO CONVERT RHYTHM RHYTHM, FAILURE TO CONVERT Failure of a device therapy or set of therapies to terminate the arrhythmia that the therapy is meant to terminate. C63007 1198 ELECTRICAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63189 1048 FAILURE TO CONVERT TO BACK-UP BACK-UP, FAILURE TO CONVERT TO C63258 2902 DATA BACK-UP PROBLEM FDA C54451 Medical Device Problem Codes FDA CDRH C63188 2587 FAILURE TO CUT CUT, FAILURE TO C62960 2984 MECHANICS ALTERED FDA C54451 Medical Device Problem Codes FDA CDRH C63187 1142 FAILURE TO CYCLE CYCLE, FAILURE TO Issue associated with the device failing to complete a series of processes or events. C62960 2984 MECHANICS ALTERED FDA C54451 Medical Device Problem Codes FDA CDRH C63186 2338 FAILURE TO DELIVER DELIVER, FAILURE TO C62902 2991 NO FLOW 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 C63184 1211 FAILURE TO DELIVER ENERGY ENERGY, FAILURE TO DELIVER C63002 1431 OUTPUT ENERGY INCORRECT 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 2906 DEPLOYMENT ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63181 1169 FAILURE TO DISCHARGE DISCHARGE, FAILURE TO Issue associated with the failure of a battery or other charge storage device to appropriately discharge as intended. C63158 1573 FAILURE TO SHOCK OR PROPERLY SHOCK 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 termination of the transfer of liquid, gas, electricity, or information cannot be accomplished, or linking components do not come apart, or disconnect, when expected. C62952 2900 CONNECTION ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63179 1175 FAILURE TO DISINFECT DISINFECT, FAILURE TO|DISINFECTION, INADEQUATE/IMPROPER C63008 2909 DEVICE DISINFECTION OR STERILIZATION ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C96715 3270 FAILURE TO EXPAND Issue associated with the device or one of its components failing to expand. C63013 2906 DEPLOYMENT ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63177 2610 FAILURE TO FIRE FIRE, FAILURE TO Issue associated with a therapy or algorithm not being delivered or executed at the expected time. C62955 2913 DEVICE OPERATES DIFFERENTLY THAN EXPECTED FDA C54451 Medical Device Problem Codes FDA CDRH C63176 1252 FAILURE TO FLUSH FLUSH, FAILURE TO C63107 2309 DEVICE RINSING ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63175 1255 FAILURE TO FOLD FOLD, FAILURE TO C63248 2976 MATERIAL DEFORMATION FDA C54451 Medical Device Problem Codes FDA CDRH C64328 2579 FAILURE TO FORM STAPLE C62960 2984 MECHANICS ALTERED FDA C54451 Medical Device Problem Codes FDA CDRH C63174 2340 FAILURE TO INFUSE INFUSE, FAILURE TO C62902 2991 NO FLOW FDA C54451 Medical Device Problem Codes FDA CDRH C63173 1332 FAILURE TO INTERROGATE INTERROGATE, FAILURE TO Issue associated with the device failure to appropriately respond to signals from a system designed to interrogate its status. C63007 1198 ELECTRICAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63172 2533 FAILURE TO OBTAIN SAMPLES SAMPLES, FAILURE TO OBTAIN C62955 2913 DEVICE OPERATES DIFFERENTLY THAN EXPECTED 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 3003 OSSEOINTEGRATION ISSUE 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 C62992 1476 FAILURE TO POWER-UP POWER-UP, FAILURE TO C63025 3010 POWER SOURCE ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63167 1492 FAILURE TO PRIME PRIME, FAILURE TO C62955 2913 DEVICE OPERATES DIFFERENTLY THAN EXPECTED FDA C54451 Medical Device Problem Codes FDA CDRH C63165 1502 FAILURE TO PUMP PUMP, FAILURE TO C62860 3016 PUMPING ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63164 1581 FAILURE TO READ INPUT SIGNAL INPUT SIGNAL, FAILURE TO READ C63271 2896 COMMUNICATION OR TRANSMISSION 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 C63163 1213 FAILURE TO REMOVE ENZYMATIC CLEANER ENZYMATIC CLEANER, FAILURE TO REMOVE C63107 2309 DEVICE RINSING ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62991 1532 FAILURE TO RESET RESET, FAILURE TO C62852 3019 RESET ISSUE 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 C62990 1466 FAILURE TO RUN ON PORTABLE MODE PORTABLE MODE, FAILURE TO RUN ON C63030 2885 BATTERY 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 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 2917 DEVICE SENSING ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63159 2547 FAILURE TO SEPARATE SEPARATE, FAILURE TO Issue associated with the device or one of its components failing to detach or separate as intended. C63013 2906 DEPLOYMENT 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 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 an appropriate or successful electrical shock. C63007 1198 ELECTRICAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62988 2939 FAILURE TO SHUT OFF Issue associated with the device not powering off when a shut down was requested. C63005 2928 ELECTRONIC PROPERTY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63157 2536 FAILURE TO SPIKE SPIKE, FAILURE TO Failure of device to generate a correctly-shaped pacing output, for example, a waveform that is too wide. C63169 1439 FAILURE TO PACE OR PROPERLY PACE FDA C54451 Medical Device Problem Codes FDA CDRH C63156 1596 FAILURE TO STERILIZE STERILIZATION FAILURE|STERILIZATION, INADEQUATE C63008 2909 DEVICE DISINFECTION OR STERILIZATION ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63155 1521 FAILURE TO TRANSMIT RECORD RECORD, FAILURE TO TRANSMIT C63271 2896 COMMUNICATION OR TRANSMISSION ISSUE 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 2976 MATERIAL DEFORMATION FDA C54451 Medical Device Problem Codes FDA CDRH C63154 2940 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 2922 DIFFICULT TO OPEN OR REMOVE PACKAGING MATERIAL FDA C54451 Medical Device Problem Codes FDA CDRH C62987 1683 FAILURE TO ZERO ZERO, FAILURE TO C62852 3019 RESET 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 C63150 1226 FALSE DEVICE OUTPUT FALSE OUTPUT C63108 2953 IMPROPER DEVICE OUTPUT 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 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 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 C63144 1233 FILLING PROBLEM Issue associated with the method or amount of time associated with the delivery of a fluid. Time to delivery or amount of delivered entity may be affected. C63075 2964 INFUSION OR FLOW ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62986 2941 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 2964 INFUSION OR FLOW ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63143 1245 FIRE Issues associated with the combustion of device components, resulting in any of the following: light, flame, smoke. C62922 3022 TEMPERATURE ISSUE 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 2900 CONNECTION 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 C63140 2942 FLARE OR FLASH Issue associated with device-related burn with an unsteady flame. C62922 3022 TEMPERATURE ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63139 2943 FLASHPOINT THRESHOLD MET Issue associated with approaching certain temperatures at which a combustible liquid ignites. C62945 2893 CHEMICAL ISSUE 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 C63135 1253 FOGGING Issue associated with the visibility of water vapor in the immediate atmosphere in which the device is being used. C62807 3027 VENTILATION ISSUE IN DEVICE ENVIRONMENT FDA C54451 Medical Device Problem Codes FDA CDRH C63134 2630 FOLDED FOLD C63296 1059 BENT FDA C54451 Medical Device Problem Codes FDA CDRH C63133 2944 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 C63132 1260 FRACTURE FRACTURE(S) OF DEVICE/MATERIAL Issue associated with any structural discontinuity in the material; collective term for cracks, splitting etc. C62973 1069 BREAK FDA C54451 Medical Device Problem Codes FDA CDRH C63130 2945 FREE OR UNRESTRICTED FLOW Issue associated with uncontrolled flow of infusion of air, gas or fluids. C63110 2954 IMPROPER FLOW OR INFUSION 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 3027 VENTILATION ISSUE IN DEVICE ENVIRONMENT 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 2887 BIOLOGICAL ENVIRONMENTAL FACTOR FDA C54451 Medical Device Problem Codes FDA CDRH C63127 2946 GAS LEAK Issue associated with the unintended escape of a gas from the container in which it is housed. C63058 1354 LEAK 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 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 2954 IMPROPER FLOW OR INFUSION 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 C64336 2947 HIGH BATTERY IMPEDANCE C64334 2884 BATTERY IMPEDANCE ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C95875 3266 HIGH CAPTURE THRESHOLD CAPTURE THRESHOLD, HIGH Issue associated with the amount of output energy needed to cause cardiac depolarization being higher than expected/desired. C63027 2891 CAPTURING ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63124 1291 HIGH IMPEDANCE IMPEDANCE, HIGH Issue associated with higher than intended electrical impedance levels between device components or device and patient connections. C63114 2950 IMPEDANCE ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62981 2426 HIGH PH PH, HIGH C62982 2910 DEVICE INGREDIENT OR REAGENT ISSUE 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 C63121 2574 HIGH SENSING THRESHOLD SENSING THRESHOLD, HIGH Issue associated with the amount of input required by the device to detect a signal being higher than expected/desired. 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 C63120 1293 HOLE IN MATERIAL HOLE(S)|HOLE Issue associated with an opening not characteristic of the normal material. C62967 2205 MATERIAL PERFORATION 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 C63118 2948 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 C76121 2949 HUMAN-DEVICE INTERFACE ISSUE C63118 2948 HUMAN FACTORS ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63117 1304 IMAGE DISPLAY ERROR Event in which measurement functions produce erroneous results or the image display is corrupted. C63088 1184 INCORRECT DISPLAY 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 2953 IMPROPER DEVICE OUTPUT 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 C63115 1358 IMAGE REVERSAL C62887 1305 IMAGE ORIENTATION INCORRECT FDA C54451 Medical Device Problem Codes FDA CDRH C63114 2950 IMPEDANCE ISSUE Issue associated with electrical impedance levels between device components or device and patient connections. C63005 2928 ELECTRONIC PROPERTY 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 C63112 2951 IMPROPER ALARM C63033 1012 DEVICE ALARM SYSTEM ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63111 2952 IMPROPER CHEMICAL REACTION Issue associated with an unexpected or inappropriate chemical reaction or effect. C62945 2893 CHEMICAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63108 2953 IMPROPER DEVICE OUTPUT Issue associated with the inaccurate outcome of a measurement/values/data obtained from the device being different from displayed, printed, stored, or exported measurements/values/data. C62941 3005 OUTPUT ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63110 2954 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 2964 INFUSION OR FLOW ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63109 1266 IMPROPER GAS OUTPUT GAS OUTPUT, IMPROPER C63108 2953 IMPROPER DEVICE OUTPUT 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 USE OF DEVICE ISSUE 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 C63105 1337 INABILITY TO IRRIGATE IRRIGATE, INABILITY TO C62902 2991 NO FLOW FDA C54451 Medical Device Problem Codes FDA CDRH C63104 2339 INACCURATE DELIVERY DELIVERY, INACCURATE C63110 2954 IMPROPER FLOW OR INFUSION FDA C54451 Medical Device Problem Codes FDA CDRH C63103 2955 INACCURATE DISPENSING C63104 2339 INACCURATE DELIVERY FDA C54451 Medical Device Problem Codes FDA CDRH C63102 1249 INACCURATE FLOWRATE FLOWRATE, INACCURATE C63110 2954 IMPROPER FLOW OR INFUSION 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 C62985 2308 INADEQUATE FILTRATION PROCESS FILTRATION PROCESS, INADEQUATE C62986 2941 FILTRATION ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63087 1319 INADEQUATE INSTRUCTIONS FOR HEALTHCARE PROFESSIONAL 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 C63267 2956 INADEQUATE INSTRUCTIONS FOR NON-HEALTHCARE PROFESSIONAL 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 C62870 2957 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 2929 ENVIRONMENTAL CONTROL OR UTILITY ISSUE 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 C63095 1600 INADEQUATE STORAGE STORAGE INADEQUATE|STORAGE, INADEQUATE Issue associated with inadequate or inappropriate storage of the device, not otherwise described. C62808 2935 FACILITIES 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. C63118 2948 HUMAN FACTORS ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63100 2958 INADEQUATE USER INTERFACE Issue associated with the means by which the operator and the equipment communicate or interact. C76121 2949 HUMAN-DEVICE INTERFACE ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63031 2959 INAPPROPRIATE OR UNEXPECTED RESET Issue associated with the inability to appropriately perform or generate any automated setting if no specific selection has made by the users. C62852 3019 RESET ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63094 2280 INAPPROPRIATE PROMPTS PROMPTS, INAPPROPRIATE C63108 2953 IMPROPER DEVICE OUTPUT FDA C54451 Medical Device Problem Codes FDA CDRH C63093 1574 INAPPROPRIATE SHOCK SHOCK, INAPPROPRIATE Issue associated with the inappropriate delivery of an electrical energy. C63158 1573 FAILURE TO SHOCK OR PROPERLY SHOCK 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 C62983 2960 INCOMPATIBILITY PROBLEM COMPATIBILITY Issue associated with the device not being compatible with another device component or substance (medication, body fluid etc) that it contains or transports. Does not refer to device issues related to disconnection. C62954 2914 DEVICE OPERATIONAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63090 2507 INCOMPLETE COAPTATION Issue associated with the heart valve leaflet not closing properly. C62923 2506 STRUCTURAL PROBLEM FDA C54451 Medical Device Problem Codes FDA CDRH C62940 2312 INCOMPLETE OR MISSING PACKAGING PACKAGING, INCOMPLETE/MISSING C63240 2916 DEVICE PACKAGING COMPROMISED FDA C54451 Medical Device Problem Codes FDA CDRH C63084 2962 INCORRECT DEVICE OR COMPONENT SHIPPED Issue associated with the delivery of an inappropriate device or device component to a user facility. C63041 2975 MANUFACTURING OR SHIPPING ISSUE ASSOCIATED WITH DEVICE 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 2953 IMPROPER DEVICE OUTPUT FDA C54451 Medical Device Problem Codes FDA CDRH C63206 2963 INCORRECT ERROR CODE C63305 2880 APPLICATION PROGRAM ISSUE 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 C63085 1383 INCORRECT MEASUREMENT MEASUREMENTS, INACCURATE C62848 1535 INCORRECT OR INADEQUATE RESULT 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 3005 OUTPUT ISSUE 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 C63081 1495 INCORRECT SOFTWARE PROGRAMMING CALCULATIONS PROGRAMMING CALCULATIONS, INCORRECT C62839 3014 PROGRAMMING ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63080 1491 INCREASE IN PRESSURE PRESSURE, INCREASE IN C62934 3012 PRESSURE ISSUE 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 C63077 1501 INCREASED PUMP SPEED PUMP SPEED, INCREASED C62860 3016 PUMPING ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63078 2535 INCREASED SENSITIVITY OVERSENSING|SENSITIVITY, INCREASED Issue with the device being more sensitive to an input than intended or expected. C63061 2293 INVALID SENSING FDA C54451 Medical Device Problem Codes FDA CDRH C63076 1310 INFLATION ISSUE INFLATION DIFFICULTIES Issue associated with the inability of a device and/or device components to expand or enlarge with the intended inflation agent (e.g. saline or air). C63075 2964 INFUSION OR FLOW ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63075 2964 INFUSION OR FLOW ISSUE Issue associated with the device failing to deliver liquids or gases as intended (e.g. delivering drugs at incorrect rate, issues with drawing fluid from a system etc). C62954 2914 DEVICE OPERATIONAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63074 2965 INSTALLATION-RELATED PROBLEM INSTALLATION ERROR Issue associated with unsatisfactory installation, configuration, and/or setup of a specific device or technology. C62808 2935 FACILITIES 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, graphic or audio/visual matter that is supplied with a medical device or its containers, wrappers; with any matter that accompanies a medical device including instructions related to identification, technical description and use of the medical device provided by the device manufacturer. C63118 2948 HUMAN FACTORS 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 3022 TEMPERATURE ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62823 2182 INSUFFICIENT FLOW OR UNDERINFUSION UNDERDELIVERY|UNDERINFUSION Issue associated with an underdose of intravenous therapy, i.e., drugs or fluids being delivered into a patient under positive pressure generated by a pump. C63075 2964 INFUSION OR FLOW ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63070 1287 INSUFFICIENT HEATING HEATING, INADEQUATE Issue associated with the device or its components producing temperatures that are not as high as what is specified. C62922 3022 TEMPERATURE ISSUE 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 2891 CAPTURING ISSUE 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 C63067 2341 INTERMITTENT INFUSION INFUSION, INTERMITTENT C63110 2954 IMPROPER FLOW OR INFUSION 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 C63061 2293 INVALID SENSING SENSING, INVALID Issue associated with the inaccuracy of a device designed to respond to an input (such as temperature, illumination, motion) to transmit a resulting signal that can not be used for interpretation or measurement. C63238 2917 DEVICE SENSING ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C76129 2967 ISSUE WITH DISPLAYED ERROR MESSAGE Issue associated with error messages that are undecipherable or which fail to prompt the user toward appropriate corrective action. C63088 1184 INCORRECT DISPLAY FDA C54451 Medical Device Problem Codes FDA CDRH C63019 2969 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 2975 MANUFACTURING OR SHIPPING ISSUE ASSOCIATED WITH DEVICE 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 C63059 1340 KNOTTED KNOT|KNOTTED MATERIAL C62962 2981 MATERIAL TWISTED FDA C54451 Medical Device Problem Codes FDA CDRH C72671 2971 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 C63058 1354 LEAK LEAK(S) Issue associated with the escape of a liquid or gas from the vessel or container in which it is housed. C62961 1384 MECHANICAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63057 2972 LIGHT INTERFERENCE C62953 3001 OPTICAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63056 1370 LOOPING C63039 2983 MECHANICAL JAM FDA C54451 Medical Device Problem Codes FDA CDRH C63055 1371 LOOSE OR INTERMITTENT CONNECTION CONNECTION(S), LOOSE C62952 2900 CONNECTION ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63257 2903 LOSS OF DATA DATA CORRUPTION|DATA LOSS Event in which information is unintentionally permanently or temporarily lost, deleted, corrupted, or overwritten. C91397 3196 DATA ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63194 1068 LOSS OF OR FAILURE TO BOND BOND, FAILURE TO Issue associated with lack or loss of adherence between materials intended to be joined together by an adhesive. C62973 1069 BREAK FDA C54451 Medical Device Problem Codes FDA CDRH C63053 2408 LOSS OF OSSEOINTEGRATION OSSEOINTEGRATION, LOSS OF C62886 3003 OSSEOINTEGRATION 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 2925 ELECTRICAL POWER PROBLEM 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 C63049 1016 LOW AUDIBLE ALARM ALARM, LOW AUDIBLE C63112 2951 IMPROPER ALARM FDA C54451 Medical Device Problem Codes FDA CDRH C63048 2584 LOW BATTERY BATTERY, LOW C63030 2885 BATTERY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C64335 2973 LOW BATTERY IMPEDANCE C64334 2884 BATTERY IMPEDANCE ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63047 2285 LOW IMPEDANCE IMPEDANCE, LOW Issue associated with lower than intended electrical impedance levels between device components or device and patient connections. C63114 2950 IMPEDANCE ISSUE 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 C63044 2575 LOW SENSING THRESHOLD SENSING THRESHOLD, LOW Issue associated with the amount of an input required by the device to detect a signal being lower than expected/desired. 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 C62978 2974 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 C63043 2616 MALPOSITION OF DEVICE MALPOSITION Issue associated with device being positioned in a location other than intended or specified. C63034 3009 POSITIONING ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63041 2975 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 3008 PHYSICAL PROPERTY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63248 2976 MATERIAL DEFORMATION Issue associated with an undesired material change in shape or property caused by external forces. C62968 2978 MATERIAL INTEGRITY 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 2978 MATERIAL INTEGRITY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63222 1177 MATERIAL DISINTEGRATION DISINTEGRATE Issue associated with material breaking into small fragments or particles. C62968 2978 MATERIAL INTEGRITY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C72894 2977 MATERIAL DISTORTION Issue associated with undesired physical appearance of device material resulting from excessive stress or impact. C62968 2978 MATERIAL INTEGRITY ISSUE 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. C62970 1153 DEGRADED FDA C54451 Medical Device Problem Codes FDA CDRH C62969 1261 MATERIAL FRAGMENTATION FRAGMENTATION Issue associated with small pieces of the device breaking off unexpectedly. C62973 1069 BREAK FDA C54451 Medical Device Problem Codes FDA CDRH C63131 1262 MATERIAL FRAYED FRAYED Issue associated with the comprising materials having damaged edges. C63248 2976 MATERIAL DEFORMATION FDA C54451 Medical Device Problem Codes FDA CDRH C62968 2978 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 3008 PHYSICAL PROPERTY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63063 1336 MATERIAL INVAGINATION INVAGINATION C63248 2976 MATERIAL DEFORMATION FDA C54451 Medical Device Problem Codes FDA CDRH C62895 1426 MATERIAL OPACIFICATION OPACIFICATION|OPAQUE Issue associated with an undesirable opaqueness or cloudiness. C62968 2978 MATERIAL INTEGRITY ISSUE 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 2978 MATERIAL INTEGRITY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C72891 2979 MATERIAL PROTRUSION Issue associated with undesired physical appearance of device material, specifically when material extends beyond or above the device surface. C62968 2978 MATERIAL INTEGRITY ISSUE 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 C62847 1544 MATERIAL RIGID OR STIFF RIGID OR STIFF|RIGID C63248 2976 MATERIAL DEFORMATION FDA C54451 Medical Device Problem Codes FDA CDRH C62965 1546 MATERIAL RUPTURE RUPTURE Issue associated with the bursting or tearing apart of a material. C62967 2205 MATERIAL PERFORATION FDA C54451 Medical Device Problem Codes FDA CDRH C62964 1562 MATERIAL SEPARATION SEPARATES|SEPARATION Issue associated with an undesired disassociation or breaking apart of device materials. C62968 2978 MATERIAL INTEGRITY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C64340 2980 MATERIAL TORQUED TORQUED Issue associated with a movement of forces that produces or tends to produce rotation or torsion of a material C62962 2981 MATERIAL TWISTED FDA C54451 Medical Device Problem Codes FDA CDRH C62962 2981 MATERIAL TWISTED TWISTING C63248 2976 MATERIAL DEFORMATION FDA C54451 Medical Device Problem Codes FDA CDRH C63040 2982 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 2960 INCOMPATIBILITY PROBLEM FDA C54451 Medical Device Problem Codes FDA CDRH C62961 1384 MECHANICAL ISSUE MECHANICAL FAILURE Issues associated with any deviations from device documented performance specifications relating to mechanical defects, including moving parts or subassemblies, etc. C62937 3008 PHYSICAL PROPERTY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63039 2983 MECHANICAL JAM Issue associated with a problem that prevents or restricts the motion of the device or its components. C62961 1384 MECHANICAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62960 2984 MECHANICS ALTERED Issue associated with modification of the moving parts or tools of the device or its components. C62961 1384 MECHANICAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C72887 2985 MEDICAL GAS SUPPLY PROBLEM Issue associated with the facility-supplied medical gases such as medical air, oxygen, nitrous oxide, and nitrogen. C63209 2929 ENVIRONMENTAL CONTROL OR UTILITY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C91396 3198 MEDICATION ERROR Event in which the device software design results in errors of medication preparation or administration. An error in medication preparation or administration attributed to software. C62839 3014 PROGRAMMING ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62908 1385 MELTED MATERIAL MOLTEN|MELTS Issue associated with a solid device or device components being transformed into a molten or liquid state. C63248 2976 MATERIAL DEFORMATION FDA C54451 Medical Device Problem Codes FDA CDRH C62918 1804 METAL SHEDDING DEBRIS DEBRIS, METAL SHEDDING C63222 1177 MATERIAL DISINTEGRATION 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 3026 UNINTENDED MOVEMENT FDA C54451 Medical Device Problem Codes FDA CDRH C62958 1398 MISASSEMBLED MISASSEMBLY Issue associated with the use of the device characterized by users' incorrect assembly of device components, parts or constituents. C62955 2913 DEVICE OPERATES DIFFERENTLY THAN EXPECTED FDA C54451 Medical Device Problem Codes FDA CDRH C79147 3133 MISASSEMBLED BY USERS C63318 1670 USE OF DEVICE 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 2900 CONNECTION ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62914 2532 MISFIRE Issue associated with failure of device to discharge its load (e.g. surgical stapler failed to partially or completely deploy its staples). C62961 1384 MECHANICAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62913 1401 MISFOCUSING C62891 1360 OPTICAL DECENTRATION FDA C54451 Medical Device Problem Codes FDA CDRH C95878 3267 MISSING TEST RESULTS TEST RESULTS, MISSING Issue associated with the results of a test or measurement not appearing. C62829 2456 INCORRECT OR INADEQUATE TEST RESULTS FDA C54451 Medical Device Problem Codes FDA CDRH C48655 3192 MISSING VALUE REASON A specific reason explaining why a meaningful value is not available. A meaningful value answers the question posed by a Data Element Concept. In contrast, a Missing Value Reason answers the implicit question "Why is there no 'meaningful' value?", when there is none. C62596 FDA C54451 Medical Device Problem Codes FDA CDRH C62910 1405 MOISTURE DAMAGE Issue associated with damage inflicted upon the device or device components from water vapor or water in the immediate environment in which the device is being used. C62909 2986 MOISTURE OR HUMIDITY PROBLEM FDA C54451 Medical Device Problem Codes FDA CDRH C62909 2986 MOISTURE OR HUMIDITY PROBLEM Issue associated with an unsatisfactory humidity level in the storage or use environment which affects device performance. C63209 2929 ENVIRONMENTAL CONTROL OR UTILITY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62907 2987 MUSHROOMED C63248 2976 MATERIAL DEFORMATION FDA C54451 Medical Device Problem Codes FDA CDRH C62906 2988 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 C64343 3191 NO CODE AVAILABLE C48655 3192 MISSING VALUE REASON 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 3005 OUTPUT 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 C62903 2990 NO FAIL-SAFE MECHANISM C62997 2936 FAIL-SAFE MECHANISM ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62902 2991 NO FLOW Issue arising from the device failing to deliver the specified liquid or gas. C63075 2964 INFUSION OR FLOW ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C53269 3190 NO INFORMATION NO ANSWER PROVIDED Information regarding the subject is unknown or inaccessible at this time. C48655 3192 MISSING VALUE REASON FDA C54451 Medical Device Problem Codes FDA CDRH C76126 2993 NO KNOWN DEVICE PROBLEM C48655 3192 MISSING VALUE REASON FDA C54451 Medical Device Problem Codes FDA CDRH C95877 3268 NO PACING Issue associated with the device ceasing to deliver paces. C63169 1439 FAILURE TO PACE OR PROPERLY PACE FDA C54451 Medical Device Problem Codes FDA CDRH C64243 2994 NO PRESSURE C62934 3012 PRESSURE 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 C99179 3273 NOISE, AUDIBLE ACOUSTIC NOISE|AUDIBLE NOISE|NOISE, ACOUSTIC An unintended or unpleasant sound that emanates from a device. C62961 1384 MECHANICAL 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 C48660 3189 NOT APPLICABLE If a value for test has to be provided, but has no given criteria (e.g., the result is for "report only" or "monitoring"). Determination of a value is not relevant in the current context. C48655 3192 MISSING VALUE REASON FDA C54451 Medical Device Problem Codes FDA CDRH C63310 1019 NOT AUDIBLE ALARM ALARM, NOT AUDIBLE C63112 2951 IMPROPER ALARM FDA C54451 Medical Device Problem Codes FDA CDRH C62897 2423 OBSTRUCTION WITHIN DEVICE OBSTRUCTION C63075 2964 INFUSION OR FLOW ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62896 1423 OCCLUSION WITHIN DEVICE OCCLUSION|PLUGGED Issue associated with an obstruction or blockage within any of the device components (e.g. tube, opening, pipe) that results in a restriction of flow. C62897 2423 OBSTRUCTION WITHIN DEVICE FDA C54451 Medical Device Problem Codes FDA CDRH C62894 2996 OPERATING SYSTEM BECOMES NON-FUNCTIONAL Issue associated with malfunction of the computer operating system as opposed to an application software issue. C63270 2898 COMPUTER OPERATING SYSTEM ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62893 2997 OPERATING SYSTEM VERSION OR UPGRADE PROBLEM Issue associated with replacing an older operation system to an up-to-date operation system. C63270 2898 COMPUTER OPERATING SYSTEM 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 3001 OPTICAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62890 2999 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 3001 OPTICAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62889 3000 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 3001 OPTICAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62953 3001 OPTICAL ISSUE Issue associated with problems transmitting visible light affecting the quality of the image transmitted or otherwise affecting the intended application of the visible light path. C62937 3008 PHYSICAL PROPERTY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62888 3002 OPTICAL OBSTRUCTION Issue associated with the blocking of optical devices, e.g., visual pathways. C62953 3001 OPTICAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62886 3003 OSSEOINTEGRATION ISSUE Issue associated with interconnection between bone tissue and implanted device. C62961 1384 MECHANICAL ISSUE 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 C62943 1432 OUTPUT ABOVE SPECIFICATIONS C63108 2953 IMPROPER DEVICE OUTPUT FDA C54451 Medical Device Problem Codes FDA CDRH C62942 3004 OUTPUT BELOW SPECIFICATIONS C63108 2953 IMPROPER DEVICE OUTPUT FDA C54451 Medical Device Problem Codes FDA CDRH C63002 1431 OUTPUT ENERGY INCORRECT C63108 2953 IMPROPER DEVICE OUTPUT FDA C54451 Medical Device Problem Codes FDA CDRH C62941 3005 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 2914 DEVICE OPERATIONAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C72890 3006 OVERCORRECTION Issue associated with an adjustment that surpasses a set criterion. C63028 2890 CALIBRATION ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62884 2404 OVERFILL C63144 1233 FILLING PROBLEM FDA C54451 Medical Device Problem Codes FDA CDRH C62883 1437 OVERHEATING OF DEVICE OR DEVICE COMPONENT OVERHEAT Issue associated with the device producing high temperatures, such that its operation is compromised (e.g. overheating that produces melting of components or automatic shutdown). C62922 3022 TEMPERATURE ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62881 1438 OVERSENSING C63061 2293 INVALID SENSING 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 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 C63097 1442 PACING INADEQUATELY Pacing voltage or pulse width is less than desired. C63169 1439 FAILURE TO PACE OR PROPERLY PACE 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 C62939 3007 PACKAGING ISSUE Issue associated with the materials used to construct the cover or outer wrapping of the device. C63041 2975 MANUFACTURING OR SHIPPING ISSUE ASSOCIATED WITH DEVICE FDA C54451 Medical Device Problem Codes FDA CDRH C63083 1449 PARAMETER CALCULATION ERROR DUE TO SOFTWARE PROBLEM PARAMETER CALCULATIONS, INCORRECT C63081 1495 INCORRECT SOFTWARE PROGRAMMING CALCULATIONS FDA C54451 Medical Device Problem Codes FDA CDRH C62879 1451 PARTICULATES Substances that consist of separate particles that are introduced by the device during use. C62845 3021 SEDIMENT, PRECIPITATE OR DEPOSIT IN DEVICE OR DEVICE INGREDIENT FDA C54451 Medical Device Problem Codes FDA CDRH C91398 3197 PATIENT DATA ISSUE Event in which information is accessed by the healthcare provider and either the wrong patient of the wrong information is retrieved despite correct inquiry procedures. The retrieval of incorrect data about a particular patient. C91397 3196 DATA ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62919 2682 PATIENT-DEVICE INCOMPATIBILITY Issue associated with the interaction between the patient's physiology or anatomy and the device that affects patient and/or device (e.g. biocompatibility issues, patient's weight exceeds safe working load of a lifting device). C62983 2960 INCOMPATIBILITY PROBLEM FDA C54451 Medical Device Problem Codes FDA CDRH C62878 1454 PEELED PEELED DEVICE MATERIAL|PEELING 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, label peeling off. C62970 1153 DEGRADED FDA C54451 Medical Device Problem Codes FDA CDRH C62876 1457 PERIVALVULAR LEAK LEAK(S), PERIVALVULAR|PARAVALVULAR LEAK(S) 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 C62937 3008 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 C62875 2578 PHYSICAL RESISTANCE RESISTANCE, PHYSICAL C63034 3009 POSITIONING ISSUE 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 C62873 1462 PLUNGE C62995 2938 FAILURE TO AUTO STOP 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 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 2953 IMPROPER DEVICE OUTPUT FDA C54451 Medical Device Problem Codes FDA CDRH C63034 3009 POSITIONING ISSUE Issue associated with the movement of the device and/or device components to an intended location. C62961 1384 MECHANICAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62916 1473 POWER CALCULATION ERROR DUE TO SOFTWARE PROBLEM POWER, MISCALCULATION OF C63081 1495 INCORRECT SOFTWARE PROGRAMMING CALCULATIONS 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, noise and other such undesirable transients. C63217 2925 ELECTRICAL POWER PROBLEM FDA C54451 Medical Device Problem Codes FDA CDRH C63025 3010 POWER SOURCE ISSUE C63007 1198 ELECTRICAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62867 1477 PRE OR POST-PUMPING PROBLEM PRE/POST-PUMPING PROBLEMS C62860 3016 PUMPING 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 3021 SEDIMENT, PRECIPITATE OR DEPOSIT IN DEVICE OR DEVICE INGREDIENT 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 2906 DEPLOYMENT ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62864 1057 PREMATURE DISCHARGE OF BATTERY BATTERY, PREMATURE DISCHARGE OF C63030 2885 BATTERY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63315 1483 PREMATURE ELECTIVE REPLACEMENT INDICATOR PREMATURE ERI C62865 3011 PREMATURE INDICATOR ACTIVATION FDA C54451 Medical Device Problem Codes FDA CDRH C63320 1480 PREMATURE END-OF-LIFE INDICATOR PREMATURE EOL C62865 3011 PREMATURE INDICATOR ACTIVATION FDA C54451 Medical Device Problem Codes FDA CDRH C62865 3011 PREMATURE INDICATOR ACTIVATION C62932 3015 PROTECTIVE MEASURE ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62934 3012 PRESSURE ISSUE Issue associated with the application of a force either internal or external to the device that compromises the flow of fluid or gas. C63075 2964 INFUSION OR FLOW ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C67507 3013 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 2880 APPLICATION PROGRAM ISSUE 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 inherent device and/or device component characteristic that is not satisfactory as specified or delivered. C63041 2975 MANUFACTURING OR SHIPPING ISSUE ASSOCIATED WITH DEVICE FDA C54451 Medical Device Problem Codes FDA CDRH C62839 3014 PROGRAMMING ISSUE Issue associated with the written program code or application software used to satisfy a stated need or objective for functioning of the device. These do not include issues associated with the operating system. C63305 2880 APPLICATION PROGRAM ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62861 2281 PROMPTS WILL NOT CLEAR C62955 2913 DEVICE OPERATES DIFFERENTLY THAN EXPECTED FDA C54451 Medical Device Problem Codes FDA CDRH C62932 3015 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 patient or caregiver or maintaining risks within specified levels. C62954 2914 DEVICE OPERATIONAL ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62860 3016 PUMPING ISSUE Issue associated with pump performance deviating from specifications in a way to compromise flow or infusion. C63075 2964 INFUSION OR FLOW ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62859 1503 PUMPING STOPPED PUMPING, STOPPED C62860 3016 PUMPING 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 C72892 3017 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 3018 RADIATION UNDEREXPOSURE Issue associated with too little radiation emitted from radiological or diagnostic devices. Results in insufficient production of normal image contrast. C62942 3004 OUTPUT BELOW SPECIFICATIONS 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 2896 COMMUNICATION OR TRANSMISSION ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62855 2314 RADIOFREQUENCY INTERFERENCE (RFI) Issue associated with the degradation of the reception of a wanted signal caused by RF disturbance. C63215 2927 ELECTROMAGNETIC COMPATIBILITY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62854 1522 REFLUX WITHIN DEVICE REFLUX Issue associated with a backward or return flow. C63110 2954 IMPROPER FLOW OR INFUSION FDA C54451 Medical Device Problem Codes FDA CDRH C62853 1524 REJECTION C62919 2682 PATIENT-DEVICE INCOMPATIBILITY FDA C54451 Medical Device Problem Codes FDA CDRH C62852 3019 RESET ISSUE Issue associated with setting a variable, register, or other storage location back to a prescribed state. C62932 3015 PROTECTIVE MEASURE ISSUE 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 DEVICE CLEANING ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62849 1248 RESTRICTED FLOWRATE FLOWRATE, RESTRICTED C63110 2954 IMPROPER FLOW OR INFUSION 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 C62846 3020 SCRATCHED MATERIAL SCRATCHED Issue associated with an undesirable shallow cut or narrow groove in the surface of the device materials. C62968 2978 MATERIAL INTEGRITY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62845 3021 SEDIMENT, PRECIPITATE OR DEPOSIT IN DEVICE OR DEVICE INGREDIENT C62982 2910 DEVICE INGREDIENT OR REAGENT 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 2906 DEPLOYMENT ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63065 1558 SENSING INTERMITTENTLY C63061 2293 INVALID SENSING 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 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 3015 PROTECTIVE MEASURE ISSUE 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 C62841 1575 SHORT FILL C63144 1233 FILLING PROBLEM 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 C62840 1584 SLIPPAGE OF DEVICE OR DEVICE COMPONENT SLIPPAGE C62950 2923 DISLODGED OR DISLOCATED 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 3022 TEMPERATURE 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 C62837 2595 SPARK Issue associated with a flash of light related to an electrical discharge in an unexpected location. C63005 2928 ELECTRONIC PROPERTY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62963 2537 SPLIT MATERIAL SPLIT|SPLITTING Issue associated with a partial or full-thickness crack in the device materials. C62968 2978 MATERIAL INTEGRITY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62836 1597 STICKING C63034 3009 POSITIONING ISSUE 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 2976 MATERIAL DEFORMATION FDA C54451 Medical Device Problem Codes FDA CDRH C62834 2538 STRIKETHROUGH C63137 1250 FLUID LEAK 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 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 2964 INFUSION OR FLOW ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62831 2385 TEAR, RIP OR HOLE IN DEVICE PACKAGING PACKAGING, TEARS, RIPS, HOLES IN C63240 2916 DEVICE PACKAGING COMPROMISED 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 2896 COMMUNICATION OR TRANSMISSION ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62922 3022 TEMPERATURE ISSUE Issue associated with the device producing unintended temperatures (for issues related to environmental/ambient temperatures refer to code C63307). C62937 3008 PHYSICAL PROPERTY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62828 3023 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 2953 IMPROPER DEVICE OUTPUT FDA C54451 Medical Device Problem Codes FDA CDRH C62858 1508 THERAPY DELIVERED TO INCORRECT BODY AREA Issue associated with the device causing unintended therapeutic action to an area of the body other than the intended area. C62955 2913 DEVICE OPERATES DIFFERENTLY THAN EXPECTED 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 2954 IMPROPER FLOW OR INFUSION 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 C62832 3024 TORN MATERIAL Issue associated with comprising material(s) being pulled apart or into pieces by force, wrenching, or laceration. C62968 2978 MATERIAL INTEGRITY ISSUE 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 2941 FILTRATION ISSUE 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 C63259 3025 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 2899 COMPUTER SYSTEM SECURITY ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62825 1659 UNCOILED C62962 2981 MATERIAL TWISTED FDA C54451 Medical Device Problem Codes FDA CDRH C62822 1661 UNDERSENSING C63061 2293 INVALID SENSING 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 C62820 1033 UNINTENDED ARM MOTION ARM MOTION, UNINTENDED C62814 3026 UNINTENDED MOVEMENT FDA C54451 Medical Device Problem Codes FDA CDRH C62819 1429 UNINTENDED COLLISION COLLISION, UNINTENDED Issue associated with device or device components impacting with another object. C62814 3026 UNINTENDED MOVEMENT FDA C54451 Medical Device Problem Codes FDA CDRH C62817 1234 UNINTENDED EJECTION FILM CARTRIDGE EJECTION, UNINTENDED Issue associated with unexpected discharge of device from expected location - includes but not limited to devices such as clip appliers, film cartridge, staples. C62955 2913 DEVICE OPERATES DIFFERENTLY THAN EXPECTED FDA C54451 Medical Device Problem Codes FDA CDRH C62818 1162 UNINTENDED ENERGIZATION DEVICE ENERGIZATION, UNINTENDED|UNINTENDED DEVICE ENERGIZATION C63025 3010 POWER SOURCE ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62816 1284 UNINTENDED HEAD MOTION HEAD MOTION, UNINTENDED C62814 3026 UNINTENDED MOVEMENT 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 C62814 3026 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 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 3026 UNINTENDED MOVEMENT FDA C54451 Medical Device Problem Codes FDA CDRH C62811 1664 UNRAVELED MATERIAL C62970 1153 DEGRADED FDA C54451 Medical Device Problem Codes FDA CDRH C62810 1444 UNSEALED DEVICE PACKAGING PACKAGING, UNSEALED C63240 2916 DEVICE PACKAGING COMPROMISED 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 3026 UNINTENDED MOVEMENT FDA C54451 Medical Device Problem Codes FDA CDRH C95876 3269 UNSTABLE CAPTURE THRESHOLD CAPTURE THRESHOLD, UNSTABLE Issue with the amount of output energy needed to cause cardiac depolarization being unstable. C63027 2891 CAPTURING ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63318 1670 USE OF DEVICE ISSUE DEVICE, INCORRECT CARE/USE OF Issue associated with user's failure to process, service, or operate the device according to the manufacturer's recommendations or recognized best practices. C63118 2948 HUMAN FACTORS ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63264 1126 USE OF 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. C63318 1670 USE OF DEVICE ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C63082 1494 USER USED INCORRECT PRODUCT FOR INTENDED USE PRODUCT, INCORRECT C63318 1670 USE OF DEVICE ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62807 3027 VENTILATION ISSUE IN DEVICE ENVIRONMENT C63209 2929 ENVIRONMENTAL CONTROL OR UTILITY ISSUE 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 3026 UNINTENDED MOVEMENT 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 C104820 3283 WIRELESS COMMUNICATION ISSUE Issue related to the transmission and reception of wireless medical device signals and data and the effects on the safety, effectiveness and functions of the medical device. These include issues related to wireless transmission and reception such as data integrity, timeliness, and reliability of transmitted signals and data. It can include issues with the RF wireless technology characteristics and performance (e.g., frequency, output power, range, reception), wireless quality of service, wireless coexistence, security of wireless signals and data, and electromagnetic compatibility. Any issue that impedes communication with a medical device that can be attributed to the wireless function. C63271 2896 COMMUNICATION OR TRANSMISSION ISSUE FDA C54451 Medical Device Problem Codes FDA CDRH C62804 2614 WRINKLED WRINKLED MATERIAL|WRINKLING C63296 1059 BENT FDA C54450 Patient Problem Codes FDA CDRH C34331 2543 ABDOMINAL CRAMPS CRAMPS, ABDOMINAL An involuntary muscular contraction involving a muscle of the abdomen or of a hollow organ within the abdomen. C34827 2193 CRAMP(S) FDA C54450 Patient Problem Codes FDA CDRH C35221 1688 ABORTION Any termination of pregnancy happening before the fetus is able to sustain independent life. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C50608 2213 ABORTION, INCOMPLETE The uterus is not entirely emptied of its contents. C35221 1688 ABORTION FDA C54450 Patient Problem Codes FDA CDRH C50613 2214 ABORTION, INDUCED ABORTION, ARTIFICIAL|ARTIFICIAL ABORTION|INDUCED ABORTION Abortion brought on intentionally. Abortion brought on intentionally. C35221 1688 ABORTION 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. C35221 1688 ABORTION 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 C26686 1690 ABSCESS An inflammatory process characterized by the accumulation of pus within a newly formed tissue cavity which is the result of a bacterial, fungal, or parasitic infection or the presence of a foreign body. C2890 1735 INFECTION, BACTERIAL 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C54685 1695 ADHESION(S) C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3353 1696 ADULT RESPIRATORY DISTRESS SYNDROME 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C7941 2682 ALTERATION IN BODY TEMPERATURE C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50458 2544 AMBULATION DIFFICULTIES DIFFICULTIES, AMBULATION C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50459 2217 AMNIONITIS Inflammation of the amnion. Inflammation of the amnion. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50410 2218 ANAPHYLACTOID Resembling anaphylaxis. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3720 3264 ANAPLASTIC LARGE CELL LYMPHOMA ALCL A peripheral (mature) T-cell lymphoma, consisting of usually large anaplastic, CD30 positive cells. The majority of cases are positive for the anaplastic large cell lymphoma (ALK) protein. The most frequently seen genetic alteration is a t(2;5) translocation. Majority of patients present with advanced disease. The most important prognostic indicator is ALK positivity, which has been associated with a favorable prognosis. (WHO, 2001) C3208 3263 LYMPHOMA FDA C54450 Patient Problem Codes FDA CDRH C50417 1028 ANASTOMOSE, FAILURE TO C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C51220 1707 ANESTHESIA, INSUFFICIENT, LIGHT OR PATCHY INSUFFICIENT, LIGHT OR PATCHY ANESTHESIA|LIGHT, PATCHY OR INSUFFICIENT ANESTHESIA|PATCHY, LIGHT OR INSUFFICIENT ANESTHESIA C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C26693 1708 ANEURYSM Bulging or ballooning in an area of an artery secondary to arterial wall weakening. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C51222 1713 ANTIBIOTICS, REACTION TO C25637 2414 REACTION 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50461 2491 AORTIC DISSECTION DISSECTION, AORTIC A progressive tear in the aorta characterized by a separation of the media layer from the outer-most layer. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C51223 1715 AORTIC INSUFFICIENCY Dysfunction of the aortic valve characterized by incomplete valve closure. C50796 1926 INSUFFICIENCY, VALVULAR 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. C51223 1715 AORTIC INSUFFICIENCY 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 2697 VALVULAR STENOSIS FDA C54450 Patient Problem Codes FDA CDRH C50416 1718 APGAR SCORE, DECREASED OR LOW DECREASED OR LOW APGAR SCORE|LOW OR DECREASED APGAR SCORE|SCORE, DECREASED OR LOW APGAR C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C15191 1719 APHERESIS C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50824 2372 APICECTOMY Excision of the apex of the petrous portion of the temporal bone. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C26698 1720 APNEA ARREST, RESPIRATORY|RESPIRATORY ARREST Cessation of breathing. Transient cessation of respiration. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C2881 1721 ARRHYTHMIA An electrocardiographic finding of any variation from the normal rate or rhythm (which may include the origin of the impulse and/or its subsequent propagation) in the heart. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C34398 1722 ARTERIOSCLEROSIS A vascular disorder characterized by thickening and hardening of the walls of the arteries. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50464 2355 ARTHRALGIA JOINT PAIN|PAIN, JOINT Pain in a joint. Pain in a joint. C3303 1994 PAIN FDA C54450 Patient Problem Codes FDA CDRH C2883 1723 ARTHRITIS An inflammatory process affecting a joint. Causes include infection, autoimmune processes, degenerative processes, and trauma. Signs and symptoms may include swelling around the affected joint and pain. 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C28245 1725 ASPIRATION The untoward medical consequence (or experience) of an unintentional inhalation of oro-pharyngeal or gastric contents into trachea or the lung airways. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C35768 1728 ATHEROSCLEROSIS Build-up of fatty material and calcium deposition in the arterial wall resulting in partial or complete occlusion of the arterial lumen. C34398 1722 ARTERIOSCLEROSIS 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. An electrocardiographic finding of a supraventricular arrhythmia characterized by the replacement of consistent P waves by rapid oscillations or fibrillatory waves that vary in size, shape and timing and are accompanied by an irregularly irregular ventricular response. (CDISC) C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C51224 1730 ATRIAL FLUTTER An electrocardiographic finding of an organized, regular atrial rhythm with atrial rate of 240-340 beats per minute. Multiple P waves typically appear in the inferior leads in a saw tooth like pattern between the QRS complexes. (CDISC) C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50467 2511 ATRIAL PERFORATION C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C35481 1731 ATRIAL TACHYCARDIA An electrocardiographic finding of an organized, regular atrial rhythm with atrial rate between 101 and 240 beats per minute. The P wave morphology must be distinct from the sinus P wave morphology. (CDISC) C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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). C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C16313 1733 AUTOIMMUNE REACTION REACTION, AUTOIMMUNE A specific humoral or cell-mediated immune response against autologous (self) antigens. An autoimmune process may produce or be caused by autoimmune disease and may be developmentally complex, not necessarily pathological, and possibly pervasive. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C51225 1736 BILIARY CIRRHOSIS CIRRHOSIS, BILIARY Cirrhosis of the liver caused either by destruction of the intrahepatic bile ducts (primary biliary cirrhosis) or blockage of the extrahepatic bile ducts (secondary biliary cirrhosis). C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50551 2229 BLINKING, EXCESSIVE EXCESSIVE BLINKING C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50447 1034 BLOOD GAS MEASUREMENTS, ABNORMAL ABNORMAL BLOOD GAS MEASUREMENTS|MEASUREMENTS, ABNORMAL BLOOD GAS C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50470 2597 BLOOD LOSS LOSS OF BLOOD C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C27123 2137 BLURRED VISION BLURRING|VISION, BLURRING OF 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) C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C39611 2668 BOWEL PERFORATION A rupture in the wall of the small or large intestine due to traumatic or pathologic processes. C4080 2001 PERFORATION FDA C54450 Patient Problem Codes FDA CDRH C37920 1751 BRADYCARDIA DECREASED HEART RATE|HEART RATE, DECREASED An electrocardiographic finding of abnormally slow heart rate. Thresholds for different age, gender, and patient populations exist. (CDISC) C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50440 2219 BRAIN INJURY BRAIN DAMAGE|INJURY, BRAIN C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C2911 1752 BRONCHITIS An acute or chronic inflammatory process affecting the bronchi. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C26710 2437 BRONCHOPNEUMONIA C3333 2011 PNEUMONIA FDA C54450 Patient Problem Codes FDA CDRH C34439 2598 BRONCHOSPASM Sudden contraction of the smooth muscles of the bronchial wall. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C3671 2348 INJURY 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. A traumatic injury involving interruption of tissue cohesiveness that results from exposure to caustic chemicals, extreme heat, extreme cold or excessive radiation. C3671 2348 INJURY FDA C54450 Patient Problem Codes FDA CDRH C50473 1756 BURN, BOWEL BOWEL BURN C34441 1757 BURN(S) FDA C54450 Patient Problem Codes FDA CDRH C50506 2523 BURN, CORNEAL CORNEAL BURN C34441 1757 BURN(S) FDA C54450 Patient Problem Codes FDA CDRH C50768 2530 BURN, THERMAL BURNS, THERMAL|THERMAL BURN A burn injury caused by heat or fire. C34441 1757 BURN(S) FDA C54450 Patient Problem Codes FDA CDRH C50476 2146 BURNING SENSATION SENSATION, BURNING A sensation of stinging or heat, not necessarily accompanied by redness or physical signs of irritation. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3672 1758 CALCIFICATION CALCIUM DEPOSIT(S)|DEPOSIT(S), CALCIUM 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. C9442 1809 DEPOSITS FDA C54450 Patient Problem Codes FDA CDRH C9305 3262 CANCER MALIGNANT NEOPLASM A tumor composed of atypical neoplastic, often pleomorphic cells that invade other tissues. Malignant neoplasms often metastasize to distant anatomic sites and may recur after excision. The most common malignant neoplasms are carcinomas (adenocarcinomas or squamous cell carcinomas), Hodgkin and non-Hodgkin lymphomas, leukemias, melanomas, and sarcomas. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C4872 1759 CANCER, BREAST BREAST CANCER A carcinoma arising from the breast, most commonly the terminal ductal-lobular unit. It is the most common malignant tumor in females. Risk factors include country of birth, family history, menstrual and reproductive history, fibrocystic disease and epithelial hyperplasia, exogenous estrogens, contraceptive agents, and ionizing radiation. The vast majority of breast carcinomas are adenocarcinomas (ductal or lobular). Breast carcinoma spreads by direct invasion, by the lymphatic route, and by the blood vessel route. The most common site of lymph node involvement is the axilla. C9305 3262 CANCER FDA C54450 Patient Problem Codes FDA CDRH C50702 2639 CAPSULAR BAG TEAR, POSTERIOR C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50478 1761 CAPSULAR CONTRACTURE The tightening of scar tissue that forms around the implant. The tightening of scar tissue that forms around the implant. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. The sudden cessation of cardiac activity in an individual who becomes unresponsive, without normal breathing and no signs of circulation. Cardiac arrest may be reversed by CPR, and/or defibrillation, cardioversion or cardiac pacing. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C73502 2513 CARDIAC PERFORATION The presence of an acquired hole in the heart. Cardiac perforation may or may not be symptomatic and may or may not be self sealing. (ACC) C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. (Sternberg Diagnostic Surgical Pathology, 3rd ed.) C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C34442 2549 CAUSTIC/CHEMICAL BURNS BURN, CAUSTIC/CHEMICAL|CHEMICAL/CAUSTIC BURN A burn caused by exposure to chemical substances. C34441 1757 BURN(S) FDA C54450 Patient Problem Codes FDA CDRH C26715 1768 CELLULITIS A bacterial infection that affects and spreads in the skin and soft tissues. Signs and symptoms include pain, tenderness and reddening in the affected area, fever, chills, and lymphadenopathy. C2890 1735 INFECTION, BACTERIAL 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50803 2133 CEREBRAL VENTRICULOMEGLIA VENTRICULOMEGLIA C50448 2078 VENTRICLE, ABNORMALITY OF FDA C54450 Patient Problem Codes FDA CDRH C50487 1772 CEREBROSPINAL FLUID LEAKAGE FLUID, LEAKAGE OF CEREBROSPINAL|LEAKAGE OF CEREBROSPINAL FLUID The loss of cerebrospinal fluid into the surrounding tissues. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3390 1770 CEREBROVASCULAR ACCIDENT CEREBROVASCULAR ACCIDENT, (CVA)|CVA, CEREBROVASCULAR ACCIDENT|STROKE SYNDROME|STROKE|SYNDROME, STROKE A sudden loss of neurological function secondary to hemorrhage or ischemia in the brain parenchyma due to a vascular event. Infarction or hemorrhage may be demonstrated either directly by imaging, laboratory, or pathologic examination in patients with symptom duration less than 24 hours, or inferred by symptoms lasting greater than or equal to 24 hours (or fatal within 24 hours) that cannot be attributed to another cause. Diagnostic tests include CT scan, MRI, angiography, and EEG to locate and evaluate the extent of the hemorrhagic or ischemic damage in the brain parenchyma, coagulation studies, complete blood count, comprehensive metabolic panel, and urinalysis. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50488 1773 CERVICAL CHANGES CERVICAL CHANGE|CHANGES, CERVICAL Changes such as abnormal, pathological, benign, malignant, etc. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C36290 2570 CHEMICAL EXPOSURE EXPOSURE, CHEMICAL C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C38665 1776 CHEST PAIN PAIN IN CHEST Pain in the chest. C3303 1994 PAIN FDA C54450 Patient Problem Codes FDA CDRH C50491 2463 CHEST TIGHTNESS/PRESSURE PRESSURE/TIGHTNESS IN CHEST|TIGHTNESS/PRESSURE IN CHEST C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C26720 1777 CHORIOAMNIONITIS Inflammation of the fetal sac membranes. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3199 2237 CHRONIC OBSTRUCTIVE PULMONARY DISEASE, (COPD) COPD, CHRONIC OBSTRUCTIVE PULMONARY DISEASE|DISEASE (COPD), CHRONIC OBSTRUCTIVE|OBSTRUCTIVE PULMONARY DISEASE (COPD), CHRONIC|PULMONARY DISEASE (COPD), CHRONIC OBSTRUCTIVE A chronic and progressive lung disorder characterized by the loss of elasticity of the bronchial tree and the air sacs, destruction of the air sacs wall, thickening of the bronchial wall, and mucous accumulation in the bronchial tree. The pathologic changes result in the disruption of the air flow in the bronchial airways. Signs and symptoms include shortness of breath, wheezing, productive cough, and chest tightness. The two main types of chronic obstructive pulmonary disease are chronic obstructive bronchitis and emphysema. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50495 2550 CLAUDICATION Limping or lameness. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50834 2626 CLOSED CAPSULOTOMY C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C34455 2228 CLOUDING, CENTRAL CORNEAL CENTRAL CORNEAL CLOUDING|CORNEAL CLOUDING, CENTRAL Diffuse edema of the central region of the cornea, usually associated with the wearing of hard contact lenses, but may also occur in keratoconus. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50497 2416 COLLAPSE C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C34497 2417 COMA COMATOSE A state of profound unconsciousness associated with markedly depressed cerebral activity. Causes include central nervous system damage, intoxication, and metabolic abnormalities. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50499 2331 COMPLAINT, ILL-DEFINED ILL-DEFINED COMPLAINT C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50501 2627 COMPLETE HEART BLOCK An electrocardiographic finding of complete failure of atrial electrical impulse conduction to the ventricles. This is manifested on the ECG by disassociation of atrial and ventricular rhythms. The atrial rate must be faster than the ventricular rate. (CDISC) C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C37928 2553 CONFUSION/DISORIENTATION DISORIENTATION/CONFUSION A mental state characterized by a lack of clear and orderly thought and behavior. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C2849 1782 CONGENITAL DEFECT/DEFORMITY DEFECT/DEFORMITY, CONGENITAL|DEFORMITY/DEFECT, CONGENITAL Any abnormality, anatomical or biochemical, evident at birth or during the neonatal period. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3080 1783 CONGESTIVE HEART FAILURE FAILURE, CONGESTIVE HEART|HEART FAILURE, CONGESTIVE Failure of the heart to pump a sufficient amount of blood to meet the needs of the body tissues, resulting in tissue congestion and edema. Signs and symptoms include shortness of breath, pitting edema, enlarged tender liver, engorged neck veins, and pulmonary rales. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C34504 1784 CONJUNCTIVITIS Inflammation of the conjunctiva of the eye. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C26729 1786 CONNECTIVE TISSUE DISEASE DISEASE, CONNECTIVE TISSUE|TISSUE DISEASE, CONNECTIVE A congenital or acquired disorder characterized by abnormalities in one or more of the elements of the connective tissues. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C37930 3274 CONSTIPATION Irregular and infrequent or difficult evacuation of the bowels. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50692 1792 CORNEA, PERFORATION OF PERFORATION OF CORNEA C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C26730 1789 CORNEAL ABRASION C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C34827 2193 CRAMP(S) C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50505 1745 CROSS-PATIENT EXPOSURE TO BODY FLUIDS BLOOD/FLUIDS, CONTAMINATION FROM|CONTAMINATION FROM BLOOD/FLUIDS|FLUIDS/BLOOD, CONTAMINATION FROM The patient becomes contaminated from contact with blood/fluids on a device. The patient becomes contaminated from contact with blood/fluids on a device. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C35375 1797 CRUSHING INJURY INJURY, CRUSHING C3671 2348 INJURY FDA C54450 Patient Problem Codes FDA CDRH C50517 2656 CUSP TEAR C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C26737 1798 CYANOSIS A bluish or purplish discoloration of the skin and mucous membranes resulting from a reduced amount of oxygenated hemoglobin in the blood. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50519 1799 CYCLITIS Inflammation of the ciliary body. Inflammation of the ciliary body. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50520 1800 CYST(S), FORMATION OF FORMATION OF CYST(S) A morphologic finding indicating the presence of cystic structures in a tissue sample. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50521 1957 CYTOMEGALOVIRAL RETINITIS RETINITIS, CYTOMEGALOVIRAL C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C14196 2220 CYTOMEGALOVIRUS (CMV) 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C27644 1801 DEAFNESS An inherited or acquired condition characterized by a partial or complete loss of hearing in one or both ears. The level of impairment varies from a mild but important loss of sensitivity to a total loss of hearing. C35731 1882 HEARING LOSS FDA C54450 Patient Problem Codes FDA CDRH C28554 1802 DEATH EXPIRED/DEATH The cessation of life. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50620 1855 DEATH, INTRAUTERINE FETAL FETAL DEATH, INTRAUTERINE|INTRAUTERINE FETAL DEATH 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C73504 2683 DECREASED SENSITIVITY C25637 2414 REACTION FDA C54450 Patient Problem Codes FDA CDRH C50527 2502 DEHISCENCE OF ORGAN A splitting open of an anatomical structure, zone, or organ with the exposure or discharge of its content. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C26740 1807 DEHYDRATED A condition resulting from the excessive loss of water from the body. It is usually caused by severe diarrhea, vomiting or diaphoresis. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C4786 1808 DEMENTIA Loss of intellectual abilities interfering with an individual's social and occupational functions. Causes include Alzheimer's disease, brain injuries, brain tumors, and vascular disorders. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C9442 1809 DEPOSITS Accumulation of extraneous inorganic matter in tissues or cavities. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C2982 2361 DEPRESSION A melancholy feeling of sadness and despair. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C26744 2253 DERMATOMYOSITIS C2889 1732 AUTOIMMUNE DISEASE FDA C54450 Patient Problem Codes FDA CDRH C26874 2047 DETACHED RETINA RETINA, DETACHED An eye emergency condition which may lead to blindness if left untreated. It is characterized by the separation of the inner retina layers from the underlying pigment epithelium. Causes include trauma, advanced diabetes mellitus, high myopia, and choroid tumors. Symptoms include sudden appearance of floaters, sudden light flushes, and blurred vision. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C62946 3165 DEVICE FRAGMENTS IN PATIENT Issue associated with the inability to retrieve device and/or device fragments during medical procedures. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C2987 1811 DIARRHEA A condition of frequent and watery bowel movements. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50492 2670 DIFFICULTY CHEWING Pain or discomfort with mastication, a symptom of underlying disease. Causes can include problems with the teeth, jaws or temporomandibular joint, mumps, cancer, or a neuromuscular disorder. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C21007 2371 DISABILITY Any physical or mental impairment that interferes with an individual's ability to perform desired activities. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50707 2655 DISC IMPINGEMENT C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50437 2225 DISCHARGE The leakage of a substance from a body orifice or break in skin integrity. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50535 2330 DISCOMFORT A feeling of mental or physical uneasiness, pain, or distress. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50536 2360 DISFIGUREMENT C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C61409 3160 DISSECTION C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C2992 1813 DISSEMINATED INTRAVASCULAR COAGULATION (DIC) COAGULATION (DIC), DISSEMINATED INTRAVASCULAR|DIC, DISSEMINATED INTRAVASCULAR COAGULATION|DISSEMINATED INTRAVASCULAR COAGULATION|INTRAVASCULAR COAGULATION (DIC), DISSEMINATED 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 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 risk of hemorrhage. C2902 1779 COAGULOPATHY FDA C54450 Patient Problem Codes FDA CDRH C50537 2601 DISTENTION C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C37942 2329 DISTRESS A state of physiological or psychological stress that cannot be compensated for by normal adaptive measures. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C37943 2194 DIZZINESS A medically indistinct term used to describe a variety of conditions such as lightheadedness, unsteadiness, giddiness, a sense of turning, spinning or rocking. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C34553 1814 DRY EYE(S) EYE(S), DRY A syndrome characterized by dryness of the cornea and conjunctiva. It is usually caused by a deficiency in tear production. Symptoms include a feeling of burning eyes and a possible foreign body presence in the eye. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C2980 1815 DYSPHAGIA A symptom referring to difficulty in swallowing. It may be observed in patients with stroke, motor neuron disorders, cancer of the throat or mouth, head and neck injuries, Parkinson disease, and multiple sclerosis. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C35546 2195 DYSPHASIA Impairment of verbal communication skills, often resulting from brain damage. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C2998 1816 DYSPNEA BREATHING DIFFICULTIES|DIFFICULTY BREATHING An uncomfortable sensation of difficulty breathing. It may present as an acute or chronic sign of an underlying respiratory or heart disorder. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C2999 2684 DYSURIA Difficulty or pain in urination. Difficulty or pain in urination. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C26758 1818 ECCHYMOSIS C26791 1888 HEMORRHAGE 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 C35468 1822 EDEMA, MACULAR MACULAR EDEMA C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50901 1823 EDEMA, MICROCYSTIC MICROCYTIC 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 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 C50543 1817 EKG/ECG CHANGES CHANGES IN EKG/ECG|ECG/EKG CHANGES Changes in cardiac electrical activity. An electrocardiographic finding of a change in cardiac electrical activity. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50541 2554 ELECTRIC SHOCK ELECTRICAL SHOCK|SHOCK, ELECTRIC|SHOCK, ELECTRICAL C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. An electrocardiographic finding of the presence of cardiac electrical rhythm without a proper response of the myocardial tissue and mechanical cardiac output. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C26759 1829 EMBOLISM The blockage of a blood vessel lumen by air or solid material such as blood clot or other tissues (e.g., adipose tissue, cancer cells) that have migrated from another anatomic site. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50489 1831 EMOTIONAL CHANGES CHANGES, EMOTIONAL C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C26760 2429 ENCEPHALITIS An acute inflammatory process affecting the brain parenchyma. Causes include viral infections and less frequently bacterial infections, toxins, and immune-mediated processes. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C26920 1833 ENCEPHALOPATHY A functional and/or structural disorder of the brain caused by diseases (e.g. liver disease, kidney disease), medications, chemicals, and injuries. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C34582 1834 ENDOCARDITIS Inflammation of the endocardium. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C34586 1835 ENDOPHTHALMITIS An infectious process affecting the internal structures of the eye. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50480 1838 ENZYME ELEVATION, CARDIAC CARDIAC ENZYME ELEVATION|ELEVATION OF CARDIAC ENZYMES C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C61375 2681 TISSUE BREAKDOWN 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C26901 1840 ERYTHEMA Red discoloration of the skin caused by infectious agents, drug hypersensitivity, or underlying diseases. C3327 2074 SKIN DISCOLORATION 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50553 2628 EXIT BLOCK An electrocardiographic finding in which impaired conduction or automaticity within the sinus node results in the failure of impulse transmission from the sinoatrial node. This is manifested as dropped P waves during sinus rhythm. (CDISC) C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C50819 2402 EXTUBATE The removal of a previously inserted tube from a hollow organ or passageway, often from the airway. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C34602 1845 EYE INJURY INJURY, EYE Damage to the eye. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C26769 1846 FACIAL NERVE PARALYSIS NERVE PARALYSIS, FACIAL|PARALYSIS OF FACIAL NERVE Partial or complete paralysis of the facial muscles of one side of a person's face. It is caused by damage to the seventh cranial nerve. It is usually temporary but it may recur. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50857 1847 FAINTING Extremely weak; threatened with syncope. Extremely weak; threatened with syncope. C50635 2418 LOSS OF CONSCIOUSNESS FDA C54450 Patient Problem Codes FDA CDRH C50558 1848 FALL A sudden movement downward, usually resulting in injury. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50559 2375 FASCIITIS Inflammation of fascia. Inflammation process in fascia. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 or accomplishment, usually accompanied by a feeling of weariness, sleepiness, or irritability. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50560 1850 FEEDING PROBLEMS PROBLEMS, FEEDING C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50563 1856 FETAL DISTRESS DISTRESS, FETAL Symptoms indicative of a state of duress to a fetus while in utero. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50566 1860 FIBROMYOSITIS Inflammation and fibrous degeneration of a muscle. Inflammation and fibrous degeneration of a muscle. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3044 3167 FIBROSIS The formation of fibrous tissue; fibroid or fibrous degeneration. The formation of fibrous tissue. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C76130 2685 FIRST-DEGREE BURN A burn that only affects the outer layer of skin causing pain, redness, and swelling. A superficial thermal, friction or chemical burn to the epidermis marked by redness, sensitivity and soreness. C34441 1757 BURN(S) FDA C54450 Patient Problem Codes FDA CDRH C3045 1862 FISTULA C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50568 1864 FLASHERS A sudden or brief burst of light. The perception of sudden or brief bursts (flashes) of light. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50569 1865 FLATUS Gas or air in the gastrointestinal tract. Gas or air in the gastrointestinal tract. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C34548 2686 FLUID DISCHARGE The pouring forth of a fluid. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50524 2430 FORCED EXPIRATORY VOLUME, DECREASED DECREASED FORCED EXPIRATORY VOLUME (FEV)|FEV (FORCED EXPIRATORY VOLUME), DECREASED|FEV DECREASED|FORCED EXPIRATORY VOLUME (FEV), DECREASED|VOLUME (FEV), DECREASED FORCED EXPIRATORY 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50609 2431 FORCED EXPIRATORY VOLUME, INCREASED FEV INCREASED|FEV, (FORCED EXPIRATORY VOLUME), INCREASED|FORCED EXPIRATORY VOLUME (FEV), 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C34620 2687 FOREIGN BODY IN PATIENT An occurrence where any object originating inside or outside the body is not in it's physiological or intended location. For example, a tooth or bone fragment being swallowed; or device's components or fragments being found in the body away from where they were implanted. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C27783 2351 FRACTURE, ARM C3046 1870 FRACTURE(S) 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 C26794 2349 FRACTURE, HIP HIP FRACTURE Traumatic or pathological injury to the hip in which the continuity of either the femoral head, femoral neck, intertrochanteric or subtrochanteric regions is broken. Symptoms include pain in the hip or groin, bruising and swelling in and around the hip area. The injured hip is turned outward and the leg appears shorter on that side. C3046 1870 FRACTURE(S) FDA C54450 Patient Problem Codes FDA CDRH C50745 2077 FRACTURE, SKULL SKULL FRACTURE A traumatic or pathologic injury to the bones of the skull in which the continuity of the bones of the skull is broken. C3046 1870 FRACTURE(S) 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. C3046 1870 FRACTURE(S) 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). C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C26780 1874 GASTRITIS Inflammation of the stomach. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C26782 1875 GLAUCOMA Increased pressure in the eyeball due to obstruction of the outflow of aqueous humor. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3064 1876 GRANULOMA An inflammatory reaction usually caused by infectious organisms, foreign bodies, or cholesterol deposits. It is characterized by the presence of epithelioid histiocytes and chronic inflammation. Often times giant cells are present. Necrosis is sometimes observed. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C50575 1877 HAIR LOSS LOSS OF HAIR Hair loss usually from the scalp. It may result in bald spots or spread to the entire scalp or the entire epidermis. It may be androgenetic or caused by chemotherapeutic agents, compulsive hair pulling, autoimmune disorders or congenital conditions. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C34660 1879 HEAD INJURY INJURY, HEAD A traumatic injury to the head. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50601 2378 HEALING, IMPAIRED IMPAIRED HEALING C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50576 1881 HEARING IMPAIRMENT IMPAIRMENT, HEARING Partial or complete loss of the ability to detect or understand sounds resulting from damage to the outer, middle, or inner ear structures. Causes include exposure to loud noise, ear infections, injuries to the ear, genetic, and congenital disorders. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C35731 1882 HEARING LOSS LOSS OF HEARING A partial or complete loss of hearing in one or both ears. It is classified as conductive, sensory, or central. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50577 2206 HEART FAILURE CARDIAC INSUFFICIENCY|FAILURE, HEART|INSUFFICIENCY, CARDIAC 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. Clinical symptoms of heart failure include: unusual dyspnea on light exertion, recurrent dyspnea occurring in the supine position, fluid retention or rales, jugular venous distension, pulmonary edema on physical exam, or pulmonary edema on chest x-ray presumed to be cardiac dysfunction. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C34670 1883 HEARTBURN C3303 1994 PAIN FDA C54450 Patient Problem Codes FDA CDRH C50578 2666 HEAVIER MENSES C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3090 2558 HEMATURIA Blood in the urine. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C37965 1886 HEMOLYSIS Disruption of the integrity of the erythrocyte membrane causing release of hemoglobin. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C34376 2279 HEMOLYTIC ANEMIA ANEMIA, HEMOLYTIC Anemia resulting from the premature destruction of the peripheral blood red cells. It may be congenital or it may be caused by infections, medications, or malignancies. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3094 1887 HEMOPTYSIS Coughing up blood from the respiratory tract. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C26791 1888 HEMORRHAGE BLEEDING The flow of blood from a ruptured blood vessel. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50485 1889 HEMORRHAGE, CEREBRAL BLEEDING, CEREBRAL|CEREBRAL BLEEDING|CEREBRAL HEMORRHAGE Hemorrhage into the cerebrum. See also Stroke Syndrome. Bleeding within the cerebrum. C50438 1891 INTRACRANIAL HEMORRHAGE 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 C50896 1892 HEMORRHAGE, INTRAVENTRICULAR INTRAVENTRICULAR HEMORRHAGE Bleeding into the brain's ventricles. C50485 1889 HEMORRHAGE, CEREBRAL 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 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 C50761 2603 HEMORRHAGE, SUBGALEAL HEMORRHAGE, SUBGALEAL Bleeding in the area between the scalp and the skull. C26791 1888 HEMORRHAGE 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 natural processes of vasoconstriction and coagulation or by surgical means. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3095 1897 HEPATITIS Inflammation of the liver; usually from a viral infection, but sometimes from toxic agents. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C34685 2240 HERNIA The protrusion of part of an organ or fibroadipose tissue through an abnormal opening. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C37966 1899 HICCUPS A diaphragmatic spasm causing a sudden inhalation which is interrupted by a spasmodic closure of the glottis, producing a noise. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50586 1297 HOST-TISSUE REACTION REACTION OF HOST-TISSUE|TISSUE, REACTION OF HOST 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 C3109 2153 HOT FLASHES FLASHES, HOT A temporary feeling of intense body warmth, flushing, sometimes accompanied by sweating. A common, symptom of menopause; other conditions that can produce hot flushes include antidepressants and drugs blocking the effect of estrogens, carcinoid tumors and a sensitivity to sulfites or other food additives. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3111 3272 HYDROCEPHALUS A disorder characterized by an abnormal increase of cerebrospinal fluid in the ventricles of the brain. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C37970 2242 HYPERNATREMIA Higher than normal levels of sodium in the circulating blood. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3117 1908 HYPERTENSION BLOOD PRESSURE, HIGH|BLOOD PRESSURE, INCREASED|HIGH BLOOD PRESSURE|INCREASED BLOOD PRESSURE|PRESSURE, HIGH BLOOD Pathological increase in blood pressure; a repeatedly elevated blood pressure exceeding 140 over 90 mmHg. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50590 1910 HYPERVENTILATION Abnormally prolonged, rapid, and deep breathing. Abnormally prolonged, rapid, and deep breathing. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50591 2664 HYPERVOLEMIA C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C50571 2354 HYPOESTHESIA, FOOT/LEG FOOT/LEG HYPOESTHESIA|LEG/FOOT HYPOESTHESIA Consisting of abnormally decreased sensitivity, particularly to touch. C50445 2352 HYPOESTHESIA 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3128 1914 HYPOTENSION BLOOD PRESSURE, DECREASED|BLOOD PRESSURE, LOW|DECREASED BLOOD PRESSURE|LOW BLOOD PRESSURE|PRESSURE, LOW BLOOD Any blood pressure that is below the normal expected for an individual in a given environment. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3890 1918 HYPOXIA A decrease in the amount of oxygen in the body. Symptoms range from mild (impaired judgment, memory loss, impaired motor coordination) to severe (seizures and coma). C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50564 2210 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 C50598 2498 IATROGENIC SOURCE SOURCE, IATROGENIC C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50599 1923 IDIOVENTRICULAR RHYTHM RHYTHM, IDIOVENTRICULAR Relating to or affecting the cardiac ventricles alone. An electrocardiographic finding of three or more consecutive complexes of ventricular origin with a rate less than a certain threshold (100 or 120 beats per minute are commonly used). The QRS complexes are wide and have an abnormal morphology. (CDISC) C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3133 1925 IMPOTENCE A disorder characterized by the persistent or recurrent inability to achieve or to maintain an erection during sexual activity. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50914 2646 INADEQUATE OSTEOINTEGRATION C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3429 1928 INCONTINENCE C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C73503 2065 INCREASED SENSITIVITY SENSITIVITY C25637 2414 REACTION 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C2890 1735 INFECTION, BACTERIAL BACTERIAL INFECTION An acute infectious disorder caused by gram positive or gram negative bacteria. Representative examples include pneumococcal , streptococcal, salmonella and meningeal infections. C26726 1930 INFECTION 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 C3245 2419 INFECTION, FUNGAL FUNGAL INFECTION An infection caused by a fungus. C26726 1930 INFECTION 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 C50617 1933 INFECTION, INTRAOCULAR INTRAOCULAR INFECTION Infection within the eye. Infection within the eye. C26726 1930 INFECTION 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 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 C35650 2420 INFECTION, UPPER RESPIRATORY TRACT An infectious process affecting the upper respiratory tract (nose, paranasal sinuses, pharynx, larynx, or trachea). Symptoms include congestion, sneezing, coughing, fever, and sore throat. C26726 1930 INFECTION FDA C54450 Patient Problem Codes FDA CDRH C50791 2120 INFECTION, URINARY TRACT TRACT, INFECTION OF URINARY|URINARY TRACT INFECTION A bacterial infectious process affecting any part of the urinary tract, most commonly the bladder and the urethra. Symptoms include urinary urgency and frequency, burning sensation during urination, lower abdominal discomfort, and cloudy urine. C26726 1930 INFECTION 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 C25754 1931 INFILTRATION OF TISSUE 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) C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 characterized by incomplete valve closure. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C34818 2665 INTERMENSTRUAL BLEEDING C26791 1888 HEMORRHAGE FDA C54450 Patient Problem Codes FDA CDRH C50616 1333 INTIMAL DISSECTION DISSECTION, INTIMAL Pertaining to the inner layer of the blood vessels. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50438 1891 INTRACRANIAL HEMORRHAGE BLEEDING, INTRACRANIAL|HEMORRHAGE, INTRACRANIAL|INTRACRANIAL BLEEDING Bleeding within the cranium. Bleeding within the cranium. C26791 1888 HEMORRHAGE FDA C54450 Patient Problem Codes FDA CDRH C50618 1937 INTRAOCULAR PRESSURE RISE INTRAOCULAR PRESSURE RISE, (IOPR)|IOPR, INTRAOCULAR PRESSURE RISE|PRESSURE (IOPR), RISE IN INTRAOCULAR|RISE IN INTRAOCULAR PRESSURE, (IOPR) Increase of pressure of the intraocular fluid in the eye. Increase of pressure of the intraocular fluid in the eye. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50786 1936 INTRAOCULAR PRESSURE, DELAYED, UNCONTROLLED DELAYED, UNCONTROLLED INTRAOCULAR PRESSURE (IOP)|INTRAOCULAR PRESSURE (IOP), DELAYED, UNCONTROLLED|IOP (INTRAOCULAR PRESSURE), DELAYED, UNCONTROLLED|IOP DELAYED, UNCONTROLLED|PRESSURE (IOP), DELAYED UNCONTROLLED INTRAOCULAR|UNCONTROLLED/DELAYED INTRAOCULAR PRESSURE (IOP) Changes in the fluid pressure inside the eye. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50619 2662 INTRAOPERATIVE PAIN C3303 1994 PAIN FDA C54450 Patient Problem Codes FDA CDRH C50621 1940 IRITIS Inflammation of the iris. Inflammation of the iris. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C34738 1942 ISCHEMIA C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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). C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3344 1943 ITCHING An intense itching sensation. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3143 2187 JAUNDICE Yellow pigmentation of the skin, mucous membranes, and the eyes due to hyperbilirubinemia. Causes include liver disease, biliary tract obstruction, and hemolysis. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C26750 2374 JOINT DISLOCATION DISLOCATED JOINT C35760 2373 JOINT DISORDER FDA C54450 Patient Problem Codes FDA CDRH C35760 2373 JOINT DISORDER DISORDER, JOINT Any disorder of the joints. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50627 2356 JOINT SWELLING SWELLING, JOINT C35760 2373 JOINT DISORDER FDA C54450 Patient Problem Codes FDA CDRH C26805 1944 KERATITIS Inflammation of the cornea. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50446 1946 LACERATION(S) C3671 2348 INJURY FDA C54450 Patient Problem Codes FDA CDRH C61390 3161 LEAD(S), BURN(S) FROM C34441 1757 BURN(S) FDA C54450 Patient Problem Codes FDA CDRH C61392 3162 LEAD(S), SHOCK FROM C35016 2072 SHOCK FDA C54450 Patient Problem Codes FDA CDRH C50629 1947 LEFT VENTRICULAR DYSFUNCTION DYSFUNCTION, LEFT VENTRICULAR|VENTRICULAR DYSFUNCTION, LEFT C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50412 2560 LETHARGIC Characterized by a lack of vitality or energy. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C50909 2671 LIMITED MOBILITY OF THE IMPLANTED JOINT C50603 1924 IMPLANT, FAILURE OF 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 C50634 1954 LIVER DYSFUNCTION DYSFUNCTION, LIVER A finding that indicates abnormal liver function. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50854 1955 LIVER LACERATION(S) LACERATION(S), LIVER C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50635 2418 LOSS OF CONSCIOUSNESS A level of awareness that can be described as consistently not responsive to stimuli. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50636 2562 LOSS OF PULSE PULSE, LOSS OF C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50641 2501 LOW CARDIAC OUTPUT CARDIAC OUTPUT, LOW|OUTPUT, LOW CARDIAC C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C27153 1956 LUPUS An autoimmune, connective tissue chronic inflammatory disorder affecting the skin, joints, kidneys, lungs, heart, and the peripheral blood cells. It is more commonly seen in women than men. Variants include discoid and systemic lupus erythematosus. C2889 1732 AUTOIMMUNE DISEASE FDA C54450 Patient Problem Codes FDA CDRH C3208 3263 LYMPHOMA A malignant (clonal) proliferation of B- lymphocytes or T- lymphocytes which involves the lymph nodes, bone marrow and/or extranodal sites. This category includes Non-Hodgkin lymphomas and Hodgkin lymphomas. C9305 3262 CANCER FDA C54450 Patient Problem Codes FDA CDRH C3832 2359 MALAISE A feeling of general discomfort or uneasiness, an out-of-sorts feeling. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50431 2370 MAMMOGRAM, ABNORMAL ABNORMAL MAMMOGRAM C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C26828 2389 MENINGITIS A disorder characterized by acute inflammation of the meninges of the brain and/or spinal cord. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50792 1871 MICTURATION URGENCY A sudden compelling urge to urinate. A sudden compelling urge to urinate. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C50432 2159 MISDIAGNOSIS C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50429 2561 MISSED DOSE DOSE, MISSED C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C48655 3192 MISSING VALUE REASON A specific reason explaining why a meaningful value is not available. A meaningful value answers the question posed by a Data Element Concept. In contrast, a Missing Value Reason answers the implicit question "Why is there no 'meaningful' value?", when there is none. C62596 FDA C54450 Patient Problem Codes FDA CDRH C50888 1963 MITRAL INSUFFICIENCY INSUFFICIENCY, MITRAL Dysfunction of the mitral valve characterized by incomplete valve closure. C50796 1926 INSUFFICIENCY, VALVULAR FDA C54450 Patient Problem Codes FDA CDRH C50653 2512 MITRAL PERFORATION PERFORATION, MITRAL C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C50888 1963 MITRAL INSUFFICIENCY 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 2697 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 C75568 3261 MULTIPLE ORGAN FAILURE A progressive condition usually characterized by combined failure of the lungs, liver, kidney, and clotting mechanisms. A progressive condition usually characterized by combined failure of the lungs, liver, kidney, and clotting mechanisms. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50657 1412 MUSCLE STIMULATION STIMULATION OF MUSCLE C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50658 1967 MUSCLE WEAKNESS WEAKNESS, MUSCULAR A reduction in the strength of one or more muscles. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50659 1968 MUSCULAR RIGIDITY RIGIDITY, MUSCULAR Stiffness or inflexibility. Stiffness or inflexibility. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C27009 2238 MYALGIA Painful sensation originating from a muscle or group of muscles. C3303 1994 PAIN FDA C54450 Patient Problem Codes FDA CDRH C50661 1763 MYOCARDIAL CONTUSION CARDIAC CONTUSION|CONTUSION, CARDIAC|CONTUSION, MYOCARDIAL A bruise to the heart. A bruise to the heart. C50441 1787 CONTUSION FDA C54450 Patient Problem Codes FDA CDRH C27996 1969 MYOCARDIAL INFARCTION INFARCTION (MI), MYOCARDIAL|MI, MYOCARDIAL INFARCTION|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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C34831 2470 MYOCARDITIS Inflammation of the muscle tissue of the heart. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50662 2466 NASAL OBSTRUCTION OBSTRUCTION, NASAL C3284 2422 OBSTRUCTION FDA C54450 Patient Problem Codes FDA CDRH C3258 1970 NAUSEA The sensation that one is about to vomit. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C16897 1971 NECROSIS A cell death process that is morphologically characterized by a gain in cell volume (oncosis), swelling of organelles, plasma membrane rupture and subsequent loss of intracellular contents. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50567 1972 NECROSIS OF FLAP TISSUE FLAP TISSUE, NECROSIS OF|TISSUE, NECROSIS OF FLAP C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 An abnormality that affects hearing within the first month after birth. It may or may not result in hearing loss. C2849 1782 CONGENITAL DEFECT/DEFORMITY FDA C54450 Patient Problem Codes FDA CDRH C50668 1976 NEONATAL HEARING LOSS HEARING LOSS, NEONATAL|LOSS OF HEARING, NEONATAL Partial or complete loss of the ability to detect or understand sounds present in an infant within its first month after birth. C2849 1782 CONGENITAL DEFECT/DEFORMITY FDA C54450 Patient Problem Codes FDA CDRH C16900 1978 NEOVASCULARIZATION The formation of new or recent blood vessels. The vasculature network is critical to the development of neoplasms. As the tumor burden grows, vascular endothial cells are recruited to form new blood vessels as an increased demand for blood and nourishment is required. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50669 1979 NERVE DAMAGE DAMAGE TO NERVE(S) C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50915 2647 NERVE PROXIMITY NOS (NOT OTHERWISE SPECIFIED) C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50787 1980 NERVE STIMULATION, UNDESIRED STIMULATION OF NERVE, UNDESIRED|UNDESIRED NERVE STIMULATION C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C4974 2689 NERVOUS SYSTEM INJURY Injury in the central or peripheral nervous system. C3671 2348 INJURY FDA C54450 Patient Problem Codes FDA CDRH C50672 1982 NEUROLOGICAL DEFICIT/DYSFUNCTION DEFICIT/DYSFUNCTION, NEUROLOGICAL|DYSFUNCTION/DEFICIT, NEUROLOGICAL A finding of pathologic function within the central or peripheral nervous system, secondary to developmental abnormalities, infections, neurologic damage, or tumors. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50673 2162 NIPPLE SENSATION, CHANGES IN/LOSS OF CHANGES IN/LOSS OF NIPPLE SENSATION|LOSS OF/CHANGES IN NIPPLE SENSATION|SENSATION, CHANGES IN/LOSS OF NIPPLE C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50674 2441 NIPPLE ULCERATION ULCERATION, NIPPLE Ulcer that develops in the nipple. Causes include trauma and Paget disease. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C64343 3191 NO CODE AVAILABLE C48655 3192 MISSING VALUE REASON FDA C54450 Patient Problem Codes FDA CDRH C50675 2199 NO CONSEQUENCES OR IMPACT TO PATIENT CONSEQUENCES OR IMPACT TO PATIENT, NONE|IMPACT OR CONSEQUENCES TO PATIENT, NONE|PATIENT, NO CONSEQUENCES OR IMPACT TO C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C53269 3190 NO INFORMATION NO ANSWER PROVIDED Information regarding the subject is unknown or inaccessible at this time. C48655 3192 MISSING VALUE REASON FDA C54450 Patient Problem Codes FDA CDRH C76143 2692 NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT C48655 3192 MISSING VALUE REASON FDA C54450 Patient Problem Codes FDA CDRH C50912 2645 NO PATIENT INVOLVEMENT C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50405 2250 NONPYROGENIC C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C48660 3189 NOT APPLICABLE If a value for test has to be provided, but has no given criteria (e.g., the result is for "report only" or "monitoring"). Determination of a value is not relevant in the current context. C48655 3192 MISSING VALUE REASON FDA C54450 Patient Problem Codes FDA CDRH C34857 2415 NUMBNESS The loss of the sensation of feeling in an area of the body. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3284 2422 OBSTRUCTION Blockage of the normal flow of the contents of an anatomical passageway. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C50849 1986 OPTICAL NERVE DAMAGE DAMAGE TO OPTICAL NERVE(S)|NERVE DAMAGE, OPTICAL C50669 1979 NERVE DAMAGE 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 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50910 2651 OSTEOPENIA BONE LOSS Decreased calcification or density of bone tissue. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50873 1988 OVERDOSE C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50850 1990 OVERSEDATED C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50683 1991 OVERSTIMULATION C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50640 2477 OXYGEN SATURATION, LOW LOW OXYGEN SATURATION|SATURATION, LOW OXYGEN 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50605 2388 PAIN RELIEF, INADEQUATE INADEQUATE PAIN RELIEF C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C26682 1685 PAIN, ABDOMINAL ABDOMINAL PAIN Painful sensation in the abdominal region. C3303 1994 PAIN FDA C54450 Patient Problem Codes FDA CDRH C50663 2433 PAIN, NECK NECK PAIN Painful sensation in the neck area. C3303 1994 PAIN FDA C54450 Patient Problem Codes FDA CDRH C50685 2468 PALLOR An unusual or extreme paleness, state of decreased skin coloration. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C37999 2467 PALPITATIONS An unpleasant sensation of irregular and/or forceful beating of the heart. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3310 1997 PARALYSIS Partial or complete loss of function of one or more muscles. It is usually caused by damage to the nervous system. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C61389 3166 PATCH TEST, ABNORMAL RESULTS OF C36292 2695 TEST RESULT FDA C54450 Patient Problem Codes FDA CDRH C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM PATIENT PROBLEM CODE|PATIENT PROBLEM C62596 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3889 2000 PELVIC INFLAMMATORY DISEASE DISEASE (PID), PELVIC INFLAMMATORY|INFLAMMATORY DISEASE (PID), PELVIC|PELVIC INFLAMMATORY DISEASE, (PID)|PID, PELVIC INFLAMMATORY DISEASE 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C3319 3271 PERICARDIAL EFFUSION Fluid collection within the pericardial sac, usually due to inflammation. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C73501 1852 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 C35136 2002 PERIPHERAL VASCULAR DISEASE DISEASE, PERIPHERAL VASCULAR|VASCULAR DISEASE, PERIPHERAL Any disorder affecting blood flow through the veins or arteries outside of the heart. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50695 2003 PERITONEAL LACERATION(S) LACERATION(S), PERITONEAL C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C26849 2252 PERITONITIS Inflammation of the peritoneum due to infection by bacteria or fungi. Causes include liver disease, perforation of the gastrointestinal tract or biliary tract, and peritoneal dialysis. Patients usually present with abdominal pain and tenderness, fever, chills, and nausea and vomiting. It is an emergency medical condition that requires prompt medical attention and treatment. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C26851 2367 PHARYNGITIS Inflammation of the throat most often caused by viral and bacterial infections. Other causes include allergens, chemical substances, and trauma. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C38003 2004 PHLEBITIS Inflammation of a vein. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50698 2165 PHOTOTOXICITY A nonimmunologic, chemically induced type of photosensitivity. A nonimmunologic, chemically induced type of photosensitivity. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50548 2327 PHYSICAL 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 C17000 2009 PLEOMORPHISM Having different forms at different stages of the life cycle. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3331 2010 PLEURAL EFFUSION EFFUSION, PLEURAL Increased amounts of fluid within the pleural cavity. Symptoms include shortness of breath, cough, and chest pain. It is usually caused by lung infections, congestive heart failure, pleural and lung tumors, connective tissue disorders, and trauma. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C38006 2012 PNEUMOTHORAX Abnormal presence of air in the pleural cavity. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C26925 1992 POLYMYOSITIS An idiopathic inflammatory disorder affecting the muscles. It presents with symmetrical proximal muscle weakness and elevated skeletal muscle enzymes. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50701 2015 POSITIVE ANTINUCLEAR ANTIBODIES (ANA) ANA, POSITIVE ANTINUCLEAR ANTIBODIES|ANTIBODIES (ANA), POSITIVE ANTINUCLEAR|ANTINUCLEAR ANTIBODIES (ANA), POSITIVE 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C25742 3193 PREGNANCY The state or condition of having a developing embryo or fetus in the body (uterus), after union of an ovum and spermatozoon, during the period from conception to birth. The state or condition of having a developing embryo or fetus in the body (uterus), after union of an ovum and spermatozoon, during the period from conception to birth. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C34945 1819 PREGNANCY, ECTOPIC ECTOPIC PREGNANCY The state or condition of having a developing embryo or fetus in the body (outside the uterus), after union of an ovum and spermatozoon, during the period from conception to birth. An abnormal pregnancy in which the egg is implanted anywhere outside the corpus uteri. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50706 2326 PRESSURE SORES/ULCERS NECROSIS, PRESSURE|PRESSURE, NECROSIS|SORES/ULCERS, PRESSURE|ULCERS/SORES, 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 C36173 2475 PROLAPSE C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50711 2605 PSEUDOANEURYSM The creation of hematoma outside the arterial wall following bleeding due to puncture of the arterial wall. Pseudoaneurysms can also occur in the heart chambers following myocardial infarction and bleeding. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C27298 2620 PTOSIS C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50585 2480 PULMONARY ARTERIAL WEDGE PRESSURE, HIGH ARTERIAL WEDGE PRESSURE, HIGH PULMONARY|HIGH PULMONARY ARTERIAL WEDGE PRESSURE|PRESSURE, HIGH PULMONARY ARTERIAL WEDGE|WEDGE PRESSURE, HIGH PULMONARY ARTERIAL 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50642 2479 PULMONARY ARTERIAL WEDGE PRESSURE, LOW ARTERIAL WEDGE PRESSURE, LOW PULMONARY|LOW PULMONARY ARTERIAL WEDGE PRESSURE|PRESSURE, LOW PULMONARY ARTERIAL WEDGE|WEDGE PRESSURE, LOW PULMONARY ARTERIAL 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50677 2481 PULMONARY ARTERIAL WEDGE PRESSURE, NORMAL ARTERIAL WEDGE PRESSURE, NORMAL PULMONARY|NORMAL PULMONARY ARTERIAL WEDGE PRESSURE|PRESSURE, NORMAL PULMONARY ARTERIAL WEDGE|WEDGE PRESSURE, NORMAL PULMONARY ARTERIAL 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50712 2019 PULMONARY DYSFUNCTION DYSFUNCTION, PULMONARY C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C26868 2020 PULMONARY EDEMA EDEMA, PULMONARY Accumulation of fluid in the lung tissues causing disturbance of the gas exchange that may lead to respiratory failure. It is caused by direct injury to the lung parenchyma or congestive heart failure. The symptoms may appear suddenly or gradually. Suddenly appearing symptoms include difficulty breathing, feeling of suffocation, and coughing associated with frothy sputum. Gradually appearing symptoms include difficulty breathing while lying in bed, shortness of breath during activity, and weight gain (in patients with congestive heart failure). C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 obstruction 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C51447 2022 PULMONARY INSUFFICIENCY INSUFFICIENCY, PULMONARY C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 2697 VALVULAR STENOSIS FDA C54450 Patient Problem Codes FDA CDRH C50533 2606 PULSE PRESSURE, DIMINISHED PULSE, DIMINISHED C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50716 2026 PUPILLARY BLOCK BLOCK, PUPILLARY An obstruction of the pupil. An obstruction of the pupil. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 2686 FLUID DISCHARGE FDA C54450 Patient Problem Codes FDA CDRH C50721 2449 QUADRIPLEGIA Paralysis of all four limbs. Paralysis of all four limbs. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C61395 3163 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 in which the R wave of a premature ventricular complex occurs on top of the T wave of the preceding beat. (CDISC) C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C61401 3164 RADIATION EXPOSURE, UNINTENDED C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50862 1510 RADIATION OVERDOSE OVERDOSE OF RADIATION C50873 1988 OVERDOSE FDA C54450 Patient Problem Codes FDA CDRH C50723 2256 RADIATION SICKNESS SYNDROME SICKNESS SYNDROME, RADIATION|SYNDROME, RADIATION SICKNESS 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). C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C52354 2166 RADIATION UNDERDOSE UNDERDOSE, RADIATION C50428 2542 UNDERDOSE 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 C50637 2032 RANGE OF MOTION, LOSS OF LOSS OF RANGE OF MOTION|MOTION, LOSS OF RANGE OF A finding that the flexibility of a joint is below the expected range of normal for that individual. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 localized 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 Raynaud's or Raynaud's disease. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C25637 2414 REACTION A response generated by a stimulus. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C25637 2414 REACTION FDA C54450 Patient Problem Codes FDA CDRH C50419 2035 REACTION, LOCAL LOCAL REACTION C25637 2414 REACTION 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C50796 1926 INSUFFICIENCY, VALVULAR FDA C54450 Patient Problem Codes FDA CDRH C50820 2403 REINFUSION The infusion of autogenic body fluid that has previously been withdrawn from the patient. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C9439 2039 RENAL DISEASE, END STAGE DISEASE (ESRD), END STAGE RENAL|END STAGE RENAL DISEASE (ESRD)|ESRD, END STAGE RENAL DISEASE|RENAL DISEASE (ESRD), END STAGE Chronic, irreversible renal failure. Long-standing and persistent renal disease with glomerular filtration rate (GFR) less than 15 ml/min. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50727 1985 REOCCLUSION C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. Acid base imbalance resulting from an accumulation of carbon dioxide secondary to hypoventilation. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C27165 2045 RESPIRATORY DISTRESS DISTRESS, RESPIRATORY A pathological increase in the effort and frequency of breathing movements. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C27560 2046 RESPIRATORY DISTRESS SYNDROME OF NEWBORNS NEWBORNS (RDS), RESPIRATORY DISTRESS SYNDROME OF|RDS OF NEWBORNS|RDS, RESPIRATORY DISTRESS SYNDROME OF NEWBORNS|RESPIRATORY DISTRESS SYNDROME OF NEWBORNS (RDS)|SYNDROME OF NEWBORNS (RDS), RESPIRATORY DISTRESS 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C26872 2484 RESPIRATORY FAILURE FAILURE, RESPIRATORY Impaired gas exchange by the respiratory system resulting in hypoxemia and decreased oxygenation of the tissues that may be associated with increased arterial levels of carbon dioxide. Causes include chronic obstructive pulmonary disease, asthma, emphysema, acute respiratory distress syndrome, pneumonia, pulmonary edema, pneumothorax, and congestive heart failure. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C34979 2049 RETINA, DEGENERATION OF DEGENERATION OF RETINA C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50732 2050 RETINA, TEAR(S) IN A usually small tearing of the retina occurring when the vitreous separates from the retina. It may lead to retinal detachment. Symptoms include flashes and floaters. C50731 2048 RETINA, DAMAGE TO FDA C54450 Patient Problem Codes FDA CDRH C34882 2053 RHEUMATIC HEART DISEASE DISEASE, RHEUMATIC HEART|HEART DISEASE, RHEUMATIC C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50733 2054 RIGHT VENTRICULAR DYSFUNCTION DYSFUNCTION, RIGHT VENTRICULAR Impairment of the right ventricular function associated with low ejection fraction and decreased motility of the right ventricular wall. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C50827 2358 SCAR EXCISION EXCISION, SCAR C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C34483 2061 SCARRING A mark left (usually on the skin) by the healing of injured tissue. C3044 3167 FIBROSIS FDA C54450 Patient Problem Codes FDA CDRH C26746 2062 SCLERODERMA A localized or systemic chronic and progressive autoimmune disorder characterized by thickening of the skin and the connective tissues. Localized scleroderma affects only the skin. Systemic scleroderma also affects internal organs, including the heart, lungs, gastrointestinal tract, and kidneys. C2889 1732 AUTOIMMUNE DISEASE FDA C54450 Patient Problem Codes FDA CDRH C76131 2694 SECOND-DEGREE BURN A partial thickness burn that affects both the outer and underlying layer of skin causing pain, redness, swelling and blistering. A burn from the epidermis to the dermal layer of the skin, usually by thermal or chemical insult. It is marked by redness, possible blistering and can provoke severe pain. C34441 1757 BURN(S) FDA C54450 Patient Problem Codes FDA CDRH C21097 2368 SEDATION The process of allaying nervous excitement or the state of being calmed. (Taber's) C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C2962 2063 SEIZURES CONVULSION Sudden, involuntary skeletal muscular contractions of cerebral or brain stem origin. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C50689 2260 SEIZURES, FOCAL FOCAL SEIZURES 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 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 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 C3364 2067 SEPSIS The presence of pathogenic microorganisms in the blood stream causing a rapidly progressing systemic reaction that may lead to shock. Symptoms include fever, chills, tachycardia, and increased respiratory rate. It is a medical emergency that requires urgent medical attention. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C35016 2072 SHOCK A life-threatening condition that requires immediate medical intervention. It is characterized by reduced blood flow that may result in damage of multiple organs. Types of shock include cardiogenic, hemorrhagic, septic, anaphylactic, and traumatic shock. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50452 1693 SHOCK, ACOUSTIC ACOUSTIC SHOCK C3671 2348 INJURY FDA C54450 Patient Problem Codes FDA CDRH C50460 1703 SHOCK, ANAPHYLACTIC ANAPHYLACTIC SHOCK|ANAPHYLAXIS 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. Progression of anaphylaxis into systemic shock, which is characterized by significant reduction in tissue perfusion which leads to hypoxia and hypotension, and can lead to death if untreated. C35016 2072 SHOCK 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 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 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 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 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 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 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 C50741 2277 SINUS, PERFORATION OF PERFORATION OF SINUS C4080 2001 PERFORATION FDA C54450 Patient Problem Codes FDA CDRH C26883 2073 SJOGREN'S SYNDROME SYNDROME, SJOGREN'S An autoimmune disorder affecting the salivary and lacrimal glands. Morphologically, it is characterized by the presence of lymphocytic and plasmacytic infiltrates which cause destruction of these glands. It results in dry mouth and dry eyes. It may be associated with the presence of other autoimmune disorders, including rheumatoid arthritis and lupus erythematosus. C2889 1732 AUTOIMMUNE DISEASE FDA C54450 Patient Problem Codes FDA CDRH C3327 2074 SKIN DISCOLORATION DISCOLORATION OF SKIN A change from the patient's baseline skin coloration. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C2983 2443 SKIN INFLAMMATION INFLAMMATION OF SKIN An inflammatory process affecting the skin. Signs include red rash, itching, and blister formation. Representative examples are contact dermatitis, atopic dermatitis, and seborrheic dermatitis. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C50624 1941 IRRITATION FDA C54450 Patient Problem Codes FDA CDRH C50744 2516 SKIN TEARS C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50746 2251 SNEEZING A symptom consisting of the involuntary expulsion of air from the nose. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50750 2432 SPINAL CORD INJURY INJURY, SPINAL CORD Traumatic damage of the spinal cord. C4974 2689 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 C35035 2083 SPRAIN C3671 2348 INJURY FDA C54450 Patient Problem Codes FDA CDRH C41330 2487 ST SEGMENT DEPRESSION DEPRESSION, ST SEGMENT An electrocardiographic finding of ST segment depression below the baseline, often described as up sloping, down sloping or horizontal. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. An electrocardiographic finding of ST segment elevation above the baseline. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50754 2263 STENOSIS STRICTURE Narrowing or stricture of a duct or canal. Narrowing or stricture of a vessel, duct or canal. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50664 2434 STIFFNESS, NECK NECK STIFFNESS C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 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. C28554 1802 DEATH 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50868 2497 SUTURE ABRASION C50449 1689 ABRASION 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3399 2091 SWELLING Enlargement; expansion in size; sign of inflammation C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50764 2092 SWOLLEN GLANDS GLANDS, SWOLLEN A clinical finding indicating that a lymph node is enlarged. Causes include viral and bacterial infections and cancers that affect the lymph nodes. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50765 2093 SWOLLEN LYMPH NODES LYMPH NODES, SWOLLEN|NODES, SWOLLEN LYMPH C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C35053 1610 SYNCOPE FAINT A spontaneous loss of consciousness caused by insufficient blood supply to the brain. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50766 2094 SYNOVITIS Inflammation of a synovial membrane. Inflammation of a synovial membrane. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C38029 2095 TACHYCARDIA HEART RATE, INCREASED|INCREASED HEART RATE An electrocardiographic finding of abnormally rapid heart rate. Thresholds for different age, gender, and patient populations exist. (CDISC) C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50552 2235 TEARING, EXCESSIVE EXCESSIVE TEARING C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50778 2427 TEETH, SENSITIVITY OF SENSITIVITY OF TOOTH C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C50916 2273 TERATOGENIC EFFECTS EFFECTS, TERATOGENIC The result of processes that negatively affect a developing fetus. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C36292 2695 TEST RESULT The outcome of a laboratory test. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50789 2099 THERAPEUTIC EFFECTS, UNEXPECTED EFFECTS, UNEXPECTED THERAPEUTIC|UNEXPECTED THERAPEUTIC EFFECTS C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50526 2271 THERAPEUTIC RESPONSE, DECREASED DECREASED THERAPEUTIC RESPONSE|RESPONSE, DECREASED THERAPEUTIC C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50611 2272 THERAPEUTIC RESPONSE, INCREASED INCREASED THERAPEUTIC RESPONSE|RESPONSE, INCREASED THERAPEUTIC C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C76132 2696 THIRD-DEGREE BURN A full thickness burn that extends into deeper tissues causing white or blackened and charred skin that may be numb. A burn that extends through all skin layers and most often includes nerve tissue. There is scarring and the affected site can be charred black or blanched white. C34441 1757 BURN(S) FDA C54450 Patient Problem Codes FDA CDRH C28195 2654 THROMBOEMBOLISM Occlusion of the lumen of a vessel by a thrombus that has migrated from a distal site via the blood stream. C26759 1829 EMBOLISM FDA C54450 Patient Problem Codes FDA CDRH C26891 2100 THROMBOSIS Formation of a blood clot in the lumen of a vessel. Causes include coagulation disorders and vascular endothelial injury. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50770 2102 THYROID PROBLEMS PROBLEMS, THYROID C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 C50773 2104 TISSUE DAMAGE DAMAGE, TISSUE C3671 2348 INJURY 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. An electrocardiographic finding of an atypical rapid polymorphic ventricular tachycardia with a characteristic rotation of the QRS complex around the isoelectric baseline, occurring in the setting of a prolonged QT interval. In addition, the QRS complex displays a periodic waxing and waning of amplitude on the electrogram. (CDISC) 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. C2890 1735 INFECTION, BACTERIAL FDA C54450 Patient Problem Codes FDA CDRH C35498 2108 TOXIC SHOCK SYNDROME SHOCK SYNDROME (TSS), TOXIC|SYNDROME (TSS), TOXIC SHOCK|TOXIC SHOCK SYNDROME, (TSS)|TSS, TOXIC SHOCK SYNDROME A severe illness caused by infection with staphylococcus aureus and characterized by high fever of sudden onset, vomiting, diarrhea, and myalgia, followed by hypotension and in severe cases, shock; a sunburn-like rash with peeling of the skin, especially of the palms and soles, occurs during the acute phase. A rare acute life-threatening systemic bacterial noncontagious illness caused by any of several related staphylococcal exotoxins. TSS characterized 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50454 2269 TOXOPLASMOSIS, ACQUIRED ACQUIRED TOXOPLASMOSIS Acquired as an adult. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50503 2270 TOXOPLASMOSIS, CONGENITAL CONGENITAL TOXOPLASMOSIS Passed from mother to fetus. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. Dysfunction of the pulmonary valve characterized by incomplete valve closure. 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. C50842 2111 TRICUSPID INSUFFICIENCY 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 2697 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3426 2274 ULCER A circumscribed inflammatory and often suppurating lesion on the skin or an internal mucous surface resulting in necrosis of tissue. C3671 2348 INJURY FDA C54450 Patient Problem Codes FDA CDRH C25757 2116 ULCERATION The formation or development of an ulcer. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50428 2542 UNDERDOSE C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C34851 2188 UREMIA C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3432 2278 URTICARIA HIVES Urticaria. An itchy skin eruption characterized by wheals 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 C50793 2121 UTERINE PERFORATION PERFORATION OF UTERUS A rupture in the uterus due to traumatic or pathologic processes. C4080 2001 PERFORATION FDA C54450 Patient Problem Codes FDA CDRH C26909 2122 UVEITIS An inflammatory process affecting a part of or the entire uvea. Causes include inflammatory agents (e.g., herpes simplex, herpes zoster, leptospirosis) and systemic diseases (e.g., inflammatory bowel disease, multiple sclerosis, systemic lupus erythematosus, ankylosing spondylitis). Patients present with pain and redness in the eye, light sensitivity, and blurred and decreased vision. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50795 2123 VAGINAL DISCHARGE DISCHARGE, VAGINAL Normal or abnormal secretions from the vagina. Mucus produced by the cervical glands is discharged from the vagina naturally, especially during the childbearing years. Causes of abnormal vaginal discharge include infectious agents (e.g., Neisseria gonorrhea, Chlamydia trachomatis, Trichomonas, and Candida albicans), the presence of foreign bodies, and cervical or vaginal cancer. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50522 2124 VAGINAL MUCOSA DAMAGE DAMAGE, VAGINAL MUCOSA|MUCOSA DAMAGE, VAGINAL C3671 2348 INJURY FDA C54450 Patient Problem Codes FDA CDRH C62433 2697 VALVULAR STENOSIS Narrowing of the opening of one or more of the four valves of the heart. C50754 2263 STENOSIS FDA C54450 Patient Problem Codes FDA CDRH C50600 2572 VASCULAR SYSTEM (CIRCULATION), IMPAIRED IMPAIRED CIRCULATION C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50798 2661 VASO-VAGAL RESPONSE Sudden drop of the blood pressure, bradycardia, and peripheral vasodilation that may lead to loss of consciousness. It results from an increase in the activity of the vagus nerve. It may be triggered by emotions of fear or pain or gastrointestinal upset and may be relieved by lying down while keeping the legs elevated. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3365 2071 VENEREAL DISEASE DISEASE (VD), VENEREAL|VD, VENEREAL DISEASE|VENEREAL DISEASE (VD) Any contagious disease acquired during sexual contact; e.g. syphilis, gonorrhea, chancroid. A disorder acquired through sexual contact. C26726 1930 INFECTION 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) C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50430 2395 VENTILATOR DEPENDENT DEPENDENT, VENTILATOR C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50448 2078 VENTRICLE, ABNORMALITY OF C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. An electrocardiographic finding of a rapid grossly irregular ventricular rhythm with marked variability in QRS cycle length, morphology, and amplitude. The rate is typically greater than 300 bpm. (CDISC) C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 by a high ventricular rate (180 to 250 beats per minute) with a regular rhythm. The electrocardiogram shows large oscillating sine wave-like complexes occurring as a result of QRS complexes and T waves being merged. The P wave is not visible. 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. An electrocardiographic finding of three or more consecutive complexes of ventricular origin with a rate greater than a certain threshold (100 or 120 beats per minute are commonly used). The QRS complexes are wide and have an abnormal morphology. (CDISC) C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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 2687 FOREIGN BODY IN PATIENT FDA C54450 Patient Problem Codes FDA CDRH C50804 2135 VESSELS, PERFORATION OF PERFORATION OF VESSEL(S) C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C14283 2136 VIRUS An infectious agent which consists of two parts, genetic material and a protein coat. These organisms lack independent metabolism, and they must infect the cells of other types of organisms to reproduce. Most viruses are capable of passing through fine filters that retain bacteria, and are not visible through a light microscope. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50602 2138 VISION, IMPAIRED IMPAIRED VISION C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50638 2139 VISION, LOSS OF LOSS OF VISION C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50805 2140 VISUAL DISTURBANCES DISTURBANCES, VISUAL C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50837 2643 VITRECTOMY Surgical removal of the vitreous humor from the chamber of the eye. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. Spots before the eyes caused by opaque cell fragments in the vitreous humor or lens. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50469 2143 VITREOUS FLUID, BLOOD IN BLOOD IN VITREOUS FLUID|FLUID, BLOOD IN VITREOUS Blood extravasation in the vitreous humor. Causes include neovascularization, retinal tear, retinal detachment, and rupture of a blood vessel aneurysm in the eye. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50639 2142 VITREOUS FLUID, LOSS OF FLUID, LOSS OF VITREOUS|LOSS OF VITREOUS FLUID C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50807 2445 VITREOUS, DETACHMENT OF DETACHMENT OF VITREOUS C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C3442 2144 VOMITING The reflex act of ejecting the contents of the stomach through the mouth. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50809 2145 WEAKNESS The property of lacking physical or mental strength; liability to failure under pressure or stress or strain. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50810 2607 WEIGHT FLUCTUATIONS FLUCTUATIONS OF WEIGHT C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM 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. C50624 1941 IRRITATION FDA C54450 Patient Problem Codes FDA CDRH C50863 1154 WOUND DEHISCENCE DEHISCENCE WOUND Separation of the layers of a surgical wound; it may be partial and superficial only, or complete with disruption of all layers. Splitting of the sutured margins of a surgical wound. Risk factors include diabetes mellitus, obesity, and advanced age. C50527 2502 DEHISCENCE OF ORGAN FDA C54450 Patient Problem Codes FDA CDRH C50704 2446 WOUND INFECTION, POST-OPERATIVE INFECTION, POST-OPERATIVE WOUND|POST-OPERATIVE WOUND INFECTION C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50705 2447 WOUND INFECTION, POST-TRAUMATIC INFECTION, POST-TRAUMATIC WOUND|POST-TRAUMATIC WOUND INFECTION C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C50435 2613 WRINKLING C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM FDA C54450 Patient Problem Codes FDA CDRH C72898 2698 ZONULAR DEHISCENCE C50527 2502 DEHISCENCE OF ORGAN