Source NCIt Subset Code FDA Subset Name NCIt Concept Code FDA Source PT FDA Source Code IMDRF Code FDA Source Synonyms(s) FDA Source Definition NCIT Definition Parent Concept's NCIt Concept Code Parent Concept's FDA Source PT Parent Concept's FDA Source Code FDA C62596 FDA Center For Devices and Radiological Health Terminology C54577 FDA Device Component Code Hierarchy Terminology used for device components or accessories in safety reports and FDA CDRH documents during both pre and post approval periods of device development and usage. C62596 CDRH Terminology FDA C62596 FDA Center For Devices and Radiological Health Terminology C54451 FDA Device Problem Code Hierarchy Terminology used for defining mode of device failure or malfunction in individual case reports for voluntary and mandatory reporting of adverse reactions or adverse events during both pre and post approval periods of device development and usage. C62596 CDRH Terminology FDA C62596 FDA Center For Devices and Radiological Health Terminology C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy Terminology that represents conclusions of an evaluation used by the CDRH with respect to reporting Medical Device events. C62596 CDRH Terminology FDA C62596 FDA Center For Devices and Radiological Health Terminology C91800 FDA Manufacturer Evaluation Method Code Hierarchy Terminology that represents methods of evaluation used by the CDRH with respect to reporting Medical Device events. C62596 CDRH Terminology FDA C62596 FDA Center For Devices and Radiological Health Terminology C91801 FDA Manufacturer Evaluation Result Code Hierarchy Terminology that represents results of evaluation used by the CDRH with respect to reporting Medical Device events. C62596 CDRH Terminology FDA C62596 FDA Center For Devices and Radiological Health Terminology C54450 FDA Patient Problem Code Hierarchy Terminology used for defining a patient condition, symptom, sign, finding, or disease in individual case reports for voluntary and mandatory reporting of adverse reactions or adverse events during both pre and post approval periods of medical device development and usage. C62596 CDRH Terminology FDA C54577 FDA Device Component Code Hierarchy C50372 Absorber 3028 A device or material designed to take in or attenuate a force or substance. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49804 Absorber (CO2) 401 A device or material designed to sequester carbon dioxide. C50372 Absorber 3028 FDA C54577 FDA Device Component Code Hierarchy C49806 Accumulator 548 A device or material designed to collect a force or substance. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49807 Actuator 402 A device designed to automate an action. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49808 Adapter (Adaptor) 431 A device designed to make different pieces of apparatus compatible. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C89528 Adhesive 3194 Any substance that affixes 2 or more parts or tissues together. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49810 Air Cleaner 552 A filtering device designed to remove particles from air. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50339 Air Eliminator 3029 A device designed to remove air from a space or fluid. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49811 Air Pump Assembly 549 A composite part of an air pump or a larger device that includes an air pump. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49813 Alarm 403 A device designed to signal the occurrence of a particular event. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49812 Alarm, Assembly 404 A composite part of an alarm or a larger device that includes an alarm. C49813 Alarm 403 FDA C54577 FDA Device Component Code Hierarchy C49814 Alarm, Audible 405 A device designed to signal the occurrence of a particular event by making a sound. C49813 Alarm 403 FDA C54577 FDA Device Component Code Hierarchy C49817 Alarm, High Inspiratory Pressure 407 A device designed to signal the occurrence of a high pressure event associated with a mechanical ventilation device. C49816 Alarm, Pressure 412 FDA C54577 FDA Device Component Code Hierarchy C49815 Alarm, LED 408 A device designed to signal the occurrence of a particular event by activating a light emitting diode. C49813 Alarm 403 FDA C54577 FDA Device Component Code Hierarchy C49819 Alarm, Low Inspiratory Pressure 409 A device designed to signal the occurrence of a low pressure event associated with a mechanical ventilation device. C49816 Alarm, Pressure 412 FDA C54577 FDA Device Component Code Hierarchy C49818 Alarm, Oxygen Pressure 410 A device designed to signal that an oxygen source pressure is outside of an established range. C49816 Alarm, Pressure 412 FDA C54577 FDA Device Component Code Hierarchy C49820 Alarm, Power 411 A device designed to signal the occurrence of a power fluctuation beyond an established range. C49813 Alarm 403 FDA C54577 FDA Device Component Code Hierarchy C49816 Alarm, Pressure 412 A device designed to signal the occurrence of a pressure fluctuation beyond an established range. C49813 Alarm 403 FDA C54577 FDA Device Component Code Hierarchy C49821 Alarm, Self 550 C49813 Alarm 403 FDA C54577 FDA Device Component Code Hierarchy C49822 Alarm, Visual 413 A device designed to signal the occurrence of a particular event in a way that can be seen. C49813 Alarm 403 FDA C54577 FDA Device Component Code Hierarchy C49823 Alarm, Volume 414 A device designed to signal that a gas volume level is outside of an established range. C49813 Alarm 403 FDA C54577 FDA Device Component Code Hierarchy C49824 Alternator 590 An electric generator designed to produce an alternating current. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50057 Altimeter 591 A device designed to measure height above the ground. C50052 Gauges/Meters 462 FDA C54577 FDA Device Component Code Hierarchy C49825 Amplifier 592 An electronic device designed to take an input signal and output an increased signal strength. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49826 Analyzer 593 Any device designed to perform an analysis. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49827 Annunciator 594 A device designed to indicate which electrical circuit is actively receiving current. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49828 Antenna 595 A device designed to transmit or receive electromagnetic signals. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50341 Applicator 3030 A device designed to transfer a substance to a surface. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49829 Arrester 596 A device designed to prevent a certain action, such as one that protects an electrical system from voltage or current surges. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49830 Attenuator 597 An electrical device designed to reduce the strength of a signal. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50317 Automatic Injection System 3031 A system designed to pump a gas or liquid into a space or environment without outside intervention. C50316 Injection System 3076 FDA C54577 FDA Device Component Code Hierarchy C49831 Backpanel 598 A rigid, removable sheet that covers the back of a device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49832 Backplane 599 A circuit board with connectors into which other cards are plugged. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49958 Bacterial Filter 417 A filter designed to remove bacteria from a gas or liquid. C49956 Filter 816 FDA C54577 FDA Device Component Code Hierarchy C49833 Baffle 730 A plate or similar structure designed to direct the flow of a fluid or dissipate its energy. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49834 Bags 553 A flexible container, often with a single opening. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49835 Ball 418 Any device that is spherical in shape. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49836 Ballast 731 An electrical device designed to limit an electric current or to provide a starting voltage. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49837 Balloon 419 Any of various types of bags designed to be distended. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49838 Barrier 732 A structure or object that impedes free movement. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49839 Battery 420 A device designed to produce an electric current through chemical reaction. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50346 Battery Charger 3032 A device designed to restore the capacity of a battery. C49868 Charger 426 FDA C54577 FDA Device Component Code Hierarchy C49841 Beam Splitter 733 An optical device designed to take an electromagnetic beam and separate it into two or more parts. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49842 Bearings 734 A point of contact between moving parts designed for support or to reduce friction. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C51066 Bed, Assist Bar 3033 Handle-like devices designed to facilitate a person's ability to get upright and out of a bed. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49843 Bell 735 A device designed to make a ringing sound when struck. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49844 Belt 737 A device consisting of a narrow loop of material moving over shafts or pulleys. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49845 Blower 738 A device designed to produce a stream of air. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49846 Bobbin 739 A device around which thread, tape, or other flexible material can be wound. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50056 Bolometer 740 A device designed to measure heat radiation. C50052 Gauges/Meters 462 FDA C54577 FDA Device Component Code Hierarchy C49847 Bolt 741 A screw designed to thread into a nut to form a fastener. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50289 Bolus Mechanism 3034 A device designed to deliver a bolus into a system. C50285 Mechanism 3085 FDA C54577 FDA Device Component Code Hierarchy C49848 Bottom Dead Center Sensor Bracket 554 A bracket designed for holding a bottom dead center sensor. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49849 Brake 742 A device designed to slow or stop a moving part. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49850 Breathing Circuit 422 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. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49851 Brush 743 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. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50354 Bubble Detector 3035 A device designed to signal the presence of bubbles in a system. C49916 Detector 787 FDA C54577 FDA Device Component Code Hierarchy C49852 Bus 745 A set of electrical conductors designed to route data from multiple locations in a computer. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49853 Bushing 746 A cylindrical metal sleeve designed to reduce the friction of a rotating shaft. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49854 Buzzer 736 An electronic signaling device designed to make a buzzing sound by vibration of an armature. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49855 Cable 423 A long, thin, multistranded rope or rope-like object; a multistranded conductor designed to carry signals over a distance. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49857 Calibrator 747 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. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49858 Camera 748 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. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50343 Cannula 3036 A small flexible tube inserted into a body cavity for draining off fluid or introducing medication. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50274 Cannula Guide 3037 A device designed to assist in the proper placement of a cannula. C49974 Guide 829 FDA C54577 FDA Device Component Code Hierarchy C49859 Cannula, Inner 749 The inner component of a double-cannula device, designed to be easily removable and replaceable. C50343 Cannula 3036 FDA C54577 FDA Device Component Code Hierarchy C49860 Cannula, Outer 750 The outer component of a double-cannula device, designed to be indwelling. C50343 Cannula 3036 FDA C54577 FDA Device Component Code Hierarchy C49861 Cap 424 A top (as for a bottle). C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49862 Capacitor 555 An electrical device designed to store an electric charge. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49863 Carrier 752 A device designed to facilitate the support, movement, or transport of another device or object. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49864 Cascade 556 A collection of interconnected devices designed to act together to repeat and enhance a signal. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49865 Cassette 425 A container designed to hold film or magnetic tape. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49866 Caster 753 A pivoting roller or wheel designed to attach to an object to make it movable. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50344 Catheter 3038 A flexible tube designed to transfer fluids into or out of the body. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50345 Cautery 3039 A device designed to coagulate and seal blood vessels or to destroy tissue with heat or electric current. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49867 Cell 754 A device that is designed as a removable and replaceable part of another device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49868 Charger 426 A device designed to restore the capacity of a system. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49869 Chassis 755 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. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49870 Choke 756 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. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49871 Circuit Board 427 A non-conducting board to which electronic components are attached. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50347 Circuit Breaker 3040 A device designed to open an electrical circuit when it becomes overloaded. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49872 Clamp 757 A device designed to hold things firmly together. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49873 Clip 758 A small device designed to hold and attach items together. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49874 Clock 759 A device designed to indicate the time of day or to measure the time duration of an event or action. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C53997 CO2 Monitor 428 A device designed to sense the level of or warn of carbon dioxide in a space or environment. C50074 Monitor 886 FDA C54577 FDA Device Component Code Hierarchy C49875 CO2 Monitor Subassembly (Only Use When Part Of Another Device) 429 A carbon dioxide monitor assembly designed to be part of another device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49876 Coder 760 A device designed to generate a code. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49877 Coil 761 A structure consisting of something wound in a continuous series of loops. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49881 Collimator 762 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. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49882 Comparator 763 A device for comparing something with a similar thing or with a standard measure. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50129 Compressor (Air Pump) 557 A pump designed to facilitate the movement or compression of air. C50128 Pump 925 FDA C54577 FDA Device Component Code Hierarchy C61402 Computer Hardware 3041 The physical components from which a computer is constructed (electronic circuits and input/output devices). C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C61403 Concentrate 3042 A reduced-volume form of the liquid that is used in a dialysis machine to carry away waste products. C76185 Device Ingredient Or Reagent 3050 FDA C54577 FDA Device Component Code Hierarchy C49883 Concentrator 558 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. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49878 Conductor Coil 559 A coil consisting of a conducting material such as that in a solenoid. C49877 Coil 761 FDA C54577 FDA Device Component Code Hierarchy C49884 Connecting Rod 560 A rod designed to transmit motion between moving parts. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49885 Connector 435 Any device or coupling designed to serve as a link between devices. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50295 Connector Pin 3043 A projecting part of a device that allows it to be secured through an opening. C50101 Pin 906 FDA C54577 FDA Device Component Code Hierarchy C50031 Contact Lens 764 A corrective, cosmetic, or therapeutic lens placed on the cornea of the eye. C50030 Lenses 866 FDA C54577 FDA Device Component Code Hierarchy C50204 Control Switches 436 A switch designed to control or regulate the operation of a device. C50199 Switches 519 FDA C54577 FDA Device Component Code Hierarchy C49887 Controller 765 A device designed to control or regulate the operation of another device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49888 Converter 766 A device designed to change a substance, form, or state into another. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50319 Cooling Module 3044 Cooling System A device designed to regulate and lower the temperature of a heat generating device or system. C50311 System 3116 FDA C54577 FDA Device Component Code Hierarchy C49890 Cord 768 A flexible cable designed to connect electronic devices. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49893 Core 769 A rod that sits within a coil, or a general term referring to the central, main part of a device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49894 Counter 770 A device designed to keep track of the number of times something happens. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50352 Counterbalance 3045 A weight designed to counteract the effects of another weight. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49895 Coupler 771 Any device designed to connect other objects. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49896 Cover 772 An object designed to conceal, enclose, cap, or protect something. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50332 CPU (Central Processing Unit Of Computer System) 3046 The part of a computer which controls all the other parts. Designs vary widely but, in general, the CPU consists of the control unit, the arithmetic and logic unit (ALU) and memory (registers, cache, RAM and ROM) as well as various temporary buffers and other logic. C61402 Computer Hardware 3041 FDA C54577 FDA Device Component Code Hierarchy C49897 CPU (Central Processing Unit) Board 437 The main circuit board housing the central processing unit. C61402 Computer Hardware 3041 FDA C54577 FDA Device Component Code Hierarchy C49898 Crank Arm Assembly 561 An extension to a shaft designed to impart a rotational energy to the shaft. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50238 CRT (Cathode Ray Tube) 438 An evacuated glass tube designed to accelerate electrons onto a screen to create images. C50236 Tube 525 FDA C54577 FDA Device Component Code Hierarchy C49899 Crystal 773 A clear cover over an instrument or any crystalline element component of an electronic device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49900 Cuff 562 A bandlike device or structure that encircles a body part or another device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50165 Cup Seal 563 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 Seal 432 FDA C54577 FDA Device Component Code Hierarchy C49901 Cups 774 Any part of a device that resembles a bowl-shaped container. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49902 Current Limiter 775 A device designed to maintain a current at a specified level regardless of other fluctuations in the system. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49903 Current Source 776 An electronic device designed to generate a constant current. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49904 Cusp 439 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. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49905 Cutter 777 A device designed to slice or sever a material. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50342 Cutter-Torque Cable 3047 A cable designed to drive the rotational cutter of a catheter device. C49855 Cable 423 FDA C54577 FDA Device Component Code Hierarchy C49906 Cylinder 440 Any part of a device that resembles an enclosed tube; a cylindrical container for the storage of gases and fluids. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50259 Cylinder Valve 441 A valve designed to regulate the flow from a storage cylinder. C50243 Valve 527 FDA C54577 FDA Device Component Code Hierarchy C49907 Damper 778 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 system. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50241 Data Acquisition Unit 779 A device designed to automatically receive and store data and format it for later use. C50329 Unit 3127 FDA C54577 FDA Device Component Code Hierarchy C49908 Decoder 780 A device designed to convert a coded signal or message to an uncoded version. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49909 Defibrillator Paddles 442 The part of a defibrillator designed to be placed in contact with the body. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49910 Defibrillator Subassembly (Only Use When Part Of Another Device) 443 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 Device Subassembly 3051 FDA C54577 FDA Device Component Code Hierarchy C49911 Dehumidifier 781 A device designed to remove moisture from the air. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49912 Dehydrator 782 A device designed to remove moisture from a substance or material. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50353 Deionizer 3048 A device designed to remove ions from a substance or environment. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49913 Delay Line 783 A communication or electronic circuit designed to delay the transmission of a signal by a set amount. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49914 Demagnetizer 784 A device designed to remove the magnetic properties of an object or material. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49915 Demodulator 785 A device designed to isolate a data signal from a carrier wave. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50055 Densitometer 786 A device designed to measure density. C50052 Gauges/Meters 462 FDA C54577 FDA Device Component Code Hierarchy C49916 Detector 787 A device designed to signal the presence of a specific condition. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49918 Device Deployer 788 A device designed to install something or distribute something in a systematic way. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C76185 Device Ingredient Or Reagent 3050 A consumable material that is added to a device and is used to make a finished product or becomes part of a finished product. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C53996 Device Subassembly 3051 A largely self-contained device designed to be incorporated into a larger device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49919 Dial 789 Either a circular indicator or a control knob on a device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49920 Diaphragm 445 A device consisting of a flexible sheet or partition. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49921 Digitizer 790 A device designed to convert analog signal to digital signal. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49922 Diode 447 An electronic component designed to pass current in one direction only. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49924 Discrete Component/Device (Resistor, Capacitor, Diode) 448 A device that exists separate from other devices; can refer to electronic components that are not part of an integrated circuit. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49925 Disk 791 Any device component shaped like a disk, especially those used for data storage. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49927 Display 416 A device designed to present information visually. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49928 Divider 792 C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49929 Dome 793 A device component designed with a hemispherical shape. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49930 Doubler 794 An amplifier that doubles the voltage or frequency of an input signal. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49931 Driver 795 A computer interface designed to control the interaction between a CPU and a peripheral device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49932 Duct 796 A device structure designed to channel the movement of gas or liquid. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49933 Dummy Load 797 A simple electronic device used for testing purposes designed to draw the same current as a complex device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49934 Duplexer 798 An electronic switching device that allows an antenna to be used for both transmitting and receiving. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50075 EKG/ECG Monitor 450 A device designed to give a continuous reading of the electrical currents of the heart. C50074 Monitor 886 FDA C54577 FDA Device Component Code Hierarchy C49935 EKG/ECG Subassembly (Only Use When Part Of Another Device) 449 An electronic device designed to record the electric currents of a beating heart, as part of a larger device. C53996 Device Subassembly 3051 FDA C54577 FDA Device Component Code Hierarchy C50027 Electrical Lead 452 C50282 Lead 3079 FDA C54577 FDA Device Component Code Hierarchy C50336 Electrical Wire 3052 A wire designed for electrical transmission of signal or power. C50269 Wire 430 FDA C54577 FDA Device Component Code Hierarchy C49936 Electrode 451 A conductor that is designed to make contact with part of a circuit or system. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50351 Electrode Contact 3053 A connector on a device designed to couple with an electrode. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50308 Emergency Stop Button Or Switch 3054 A button and circuits designed to force the shutdown of a machine or device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50309 Emergency Table Stop 3055 A mechanism designed to quickly halt the movement of a feed table. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49937 Emitter 799 The electron source electrode in a transistor or any source in a system. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49938 Enclosure 800 A structure designed to house a device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49939 Encoder 801 A device designed to covert a signal or message to a coded version. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49940 Endoscope 802 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. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50338 Endoscopic Accessory 3056 A supplementary device or component designed to work with an endoscope. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50049 EPROM (Erasable Programmable Read Only Memory) 454 A type of read only memory device that can be written to after manufacture, erased, and reused. C50050 PROM (Programmable Read Only Memory) 503 FDA C54577 FDA Device Component Code Hierarchy C49941 Equalizer 803 An electronic device designed to alter the frequency of a signal, usually to adjust for distortion. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49942 Evaporator 804 A device designed either to drive a volatile solvent from a material or to cause vaporization within a heating/cooling system. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49957 Exhalation Filter 455 A filter designed to remove something from the expiration stream of a ventilator. C49956 Filter 816 FDA C54577 FDA Device Component Code Hierarchy C49943 Expander 805 A device designed to stretch or enlarge a structure. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49944 Extender 806 A device designed to lengthen a structure. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50359 External Fiberoptic 3057 A fiberoptic device designed to remain outside of the body. C50358 Fiberoptic 3059 FDA C54577 FDA Device Component Code Hierarchy C49945 Extractor 807 A device designed to remove or separate a material or object from some other material or object. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49946 Eyelet 808 A device designed to create a hole in an object for the passage of a cord. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50208 Fail-Safe System 456 A device designed to prevent malfunction, unsafe, or unauthorized operation of a device or system. C50311 System 3116 FDA C54577 FDA Device Component Code Hierarchy C49947 Fan 809 A device designed to create an air current through the rotation of a planar surface. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49948 Fastener 810 A device designed to hold something in place. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49949 Feedthru 811 A device designed to allow a connection to pass through a structural component of a device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49950 Ferrule 812 A metal cap designed to strengthen the end of an implement. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49951 FET (Field Effect Transistor) 813 A transistor designed so that current through it is controlled by a variable electric field. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49952 Fiber 814 Any device made from a long, slender material. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50362 Fiberguide 3058 A device designed to assist in installation of fiberoptic cables. C49974 Guide 829 FDA C54577 FDA Device Component Code Hierarchy C50358 Fiberoptic 3059 A device made with thin fibers of glass or plastic as a conduit for the transmission of light. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50348 Fiberoptic Cladding 3060 A material designed to form an outer protective surface on an optical fiber. C50358 Fiberoptic 3059 FDA C54577 FDA Device Component Code Hierarchy C50349 Fiberoptic Cleaver 3061 A device designed for cutting an optical fiber and processing the ends for attachment. C50358 Fiberoptic 3059 FDA C54577 FDA Device Component Code Hierarchy C49955 Film 815 A photographic material designed to capture an image upon exposure to electromagnetic radiation. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C76119 Film Cartridge 3062 A device to hold an amount of film and facilitate its loading into a device. C49955 Film 815 FDA C54577 FDA Device Component Code Hierarchy C69444 Film Processor 3063 A device designed to chemically treat film to develop the images on it. C50122 Processor 919 FDA C54577 FDA Device Component Code Hierarchy C49956 Filter 816 A device designed to remove something from whatever passes through it. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49959 Flange 457 A protruding edge designed to strengthen or stabilize a device or facilitate its attachment to a surface. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49960 Flasher 817 An electric device designed to repeatedly and rapidly turn a light on and off. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50054 Flowmeter 458 A device designed to measure the flow rate of a fluid. C50052 Gauges/Meters 462 FDA C54577 FDA Device Component Code Hierarchy C49961 Foil 818 A thin, flexible sheet of metal. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49962 Foot Pedal 819 A lever designed to be operated with the foot. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50202 Foot Switch 459 A switch designed to be actuated by foot pressure. C50199 Switches 519 FDA C54577 FDA Device Component Code Hierarchy C49963 Frame 820 A structure designed to support or contain an object. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50002 Function Indicator 460 A device designed to monitor a specific function of a system. C50001 Indicator 844 FDA C54577 FDA Device Component Code Hierarchy C50284 Function Indicator Light 3064 A lighted component that is part of a function indicator. C50002 Function Indicator 460 FDA C54577 FDA Device Component Code Hierarchy C49964 Function Lid 564 C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49965 Furnace 821 An enclosed chamber designed to produce heat. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49966 Fuse 822 An electrical device designed to stop the flow of current when an overload condition exists. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50314 Gas Delivery System 3065 A system designed to supply a gas flow to another device or system. C50311 System 3116 FDA C54577 FDA Device Component Code Hierarchy C49967 Gas Scavenging 461 A device designed to remove certain gases from a gas stream or environment. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49968 Gasket 823 A preformed material designed to form a seal between connecting surfaces. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50052 Gauges/Meters 462 Meter A device designed to give a visual indication of the condition of a system. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49969 Gears 565 Gear A toothed wheel designed to mesh with another toothed object and transmit motion. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49970 Generator 825 An engine designed to produce electricity or a device designed to produce a vapor or gas. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49971 Grille 826 A framework of bars designed as a covering or divider. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49972 Grommet 827 A ring-like device designed for lining a round opening for reinforcement or protection. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49973 Ground Strap 828 A wire cable or strap designed to carry current safely away from an electronic device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49974 Guide 829 A device designed to help direct the passage of another object. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50271 Guidewire 463 A flexible wire designed to help position medical devices within the body. C50269 Wire 430 FDA C54577 FDA Device Component Code Hierarchy C50281 Hand Immobilizer 3066 A device designed to limit the movement of the hand such as a splint for therapy or a restraint for phlebotomy. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50275 Handpiece 3067 A part of a mechanical device designed to be used while held in the hand. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50276 Handrest 3068 A part of a device designed to stabilize or support the hand. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49977 Handset 830 The part of a telephone that has the earpiece and mouthpiece and is designed to be held in the hand. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50277 Haptic 3069 A device designed to give physical feedback in a remote control system. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49978 Header 464 A pipe containing multiple feeder pipes, especially the exhaust pipe that connects to each cylinder of an engine. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49979 Headphone 831 A device with sound speakers designed to be worn on the head in proximity to the ears. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49980 Heads 832 A projection on the end of an object C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49982 Headset 833 An accessory for a telephone that is worn on the head and designed to allow hands free conversation. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49983 Heart Valve Cage 465 The part of a mechanical heart valve designed to contain and guide the occluder ball in a cage and ball valve. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50029 Heart Valve Leaflet 466 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 Leaflet 3081 FDA C54577 FDA Device Component Code Hierarchy C50150 Heart Valve Sewing Ring 834 A ring of supportive material around a heart valve designed to provide a stable surface for attachment to surrounding tissues. C50148 Ring 943 FDA C54577 FDA Device Component Code Hierarchy C49984 Heat Exchanger 835 A device designed to transfer heat between fluids across a barrier or to the environment. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49985 Heat Sink 836 A thermally conductive structure designed to carry heat away from an electronic device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49986 Heater 467 A device designed to generate heat. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49987 Heater Rod 566 The rod-like part of certain heaters from which the radiant energy is released. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49880 Helifix Coil 567 A coil designed to allow a Helifix pacing electrode to be placed in the endocardium. C49877 Coil 761 FDA C54577 FDA Device Component Code Hierarchy C50335 Hemo Valve 3070 A device component of a catheter assembly designed to prevent backflow of blood and thus minimize inadvertent blood loss while accessing the vasculature. C50243 Valve 527 FDA C54577 FDA Device Component Code Hierarchy C50302 Hermetic Seal 3071 A seal designed to be airtight. C50163 Seal 432 FDA C54577 FDA Device Component Code Hierarchy C49988 Hinge 837 A device designed to join two objects and allow them to swing relative to one another. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49989 Holder 838 A device designed to hold another object. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49953 Hollow Fiber 468 Any device made from a fiber with a hollow center, particularly those for cell propagation in culture. C49952 Fiber 814 FDA C54577 FDA Device Component Code Hierarchy C50279 Hose 3072 A flexible tube designed to carry a fluid. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50280 Hose Line 3073 A flexible tube designed to carry a fluid. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49990 Housing 839 A structural enclosure designed to contain or support a device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49991 Hub 469 An electronic device designed as a central connection for other devices. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49992 Humidifier 470 A device designed to add moisture to the air. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49993 Hybrid Circuit 471 An electronic device containing circuits of different technological types. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50313 Hydraulic Bed System 3074 A bed that includes a hydraulic system designed for movement or positioning of an object or subject. C50311 System 3116 FDA C54577 FDA Device Component Code Hierarchy C50312 Hydraulic System 3075 A system designed to use fluid pressure to bring about movement. C50311 System 3116 FDA C54577 FDA Device Component Code Hierarchy C49994 IC (Integrated Circuit) 474 A device that uses only integrated circuits. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49995 IC (Integrated Circuit) Chip 472 A microelectronic device that incorporates many interconnected transistors and components. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49996 Igniter 840 A device designed to light a fire. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49997 Imager 841 A device designed to create or record a visual representation of something. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49998 Impedance Converter 842 A device designed to change the resistance of an electric circuit. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50000 Indexer 843 A device designed to create an electronic index of information. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50001 Indicator 844 A device designed to show an operating condition of a system or to attract attention. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50003 Inductor 845 A device designed to introduce electromotive force to a circuit, usually a coil surrounding a wire. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50316 Injection System 3076 Injector System A system designed to pump a gas or liquid into a space or environment. C50311 System 3116 FDA C54577 FDA Device Component Code Hierarchy C50004 Insulation 473 A material designed to reduce the transmission of heat, sound, or electricity. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50005 Integrator 846 C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50006 Intercom 847 A communications device designed for use between rooms of a building. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50007 Interconnection Board Intubate 569 C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50008 Interface 848 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. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50009 Interrupter 849 A device designed to stop the flow of current in a circuit. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50298 Intravenous Pole 3077 A structural device designed to hang an intravenous solution bag. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50010 Inverter 850 An electrical device that converts direct current to alternating current. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49999 IOL (Intraocular Lens) Implant 851 A corrective lens that is designed to be implanted within the eye capsule to replace the natural lens. C50030 Lenses 866 FDA C54577 FDA Device Component Code Hierarchy C50011 Isolator 852 Any material or structure designed to limit the interaction between two components. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50012 Jack 853 A tool designed to lift an object. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C54020 Jaw 1028 A device designed to use opposing parts to close on and hold an object. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50013 Joint 854 A device designed as the junction between objects; it may be flexible or rigid. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50015 Joystick 855 A control device that uses a movable handle to create two-axis input for a computer device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50016 Jumper 856 A small connector designed to make temporary connections in electrical circuits. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50017 Junction 857 A device designed to join two or more things. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50018 Keyboard 475 A device consisting of mechanical keys that are pressed to create input to a computer. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50019 Keyer 858 A device designed for signaling by hand using one or more switches. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50020 Keypad 859 A device consisting of keys, usually in a block arrangement, that provides limited input to a system. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50021 Kit 860 A collection of objects or devices collected together for a particular function or purpose. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C54021 Knife 3156 A cutting device usually consisting of a sharpened blade attached to a handle. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50022 Knob 861 A handle, usually attached to a shaft allowing manual rotation of the shaft. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50023 Label 862 Any written, printed, or graphic matter upon a device to identify its nature, ownership, or other characteristic particulars of the device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50024 Laminate 863 A material consisting of multiple layers bonded together. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50025 Lamp 864 A device designed to produce light or heat. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50026 Laser 865 A device designed to emit a monochromatic beam of coherent light. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50292 Laser Nozzle 3078 A device through which a laser beam emerges. C50291 Nozzle 3092 FDA C54577 FDA Device Component Code Hierarchy C54022 Latch 1030 A fastening device for a swinging part usually consisting of a bar that is retained in a slot. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50282 Lead 3079 An insulated electrical conductor designed to connect to an electrical device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50028 Lead Conductor 476 A bundle of leads designed to connect between a pacing device and implanted heart electrodes. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50326 Lead Tip 3080 A device designed to form the end of an electrical lead. C50324 Tip 3123 FDA C54577 FDA Device Component Code Hierarchy C50283 Leaflet 3081 Any device that resembles a small leaf, especially one that has two thin blades hinged in the center. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50357 Leaflet Disk 3082 A disk-shaped valve component of a tilting disk mechanical heart valve. C50283 Leaflet 3081 FDA C54577 FDA Device Component Code Hierarchy C49923 LED (Light Emitting Diode) 477 A type of diode designed to emit light when a current passes through it. C49922 Diode 447 FDA C54577 FDA Device Component Code Hierarchy C50030 Lenses 866 An electric or optical device designed to focus electromagnetic radiation. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50201 Limit Switch 478 A switch designed to cut off power automatically to a moving object when it reaches a predetermined point. C50199 Switches 519 FDA C54577 FDA Device Component Code Hierarchy C50032 Limiter 867 An electronic device designed to prevent the amplitude of a wave from exceeding a set limit. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50033 Line Conditioner 868 An electronic device designed to improve the output quality of a power source, typically by smoothing the output voltage. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49840 Lithium Iodide Battery 479 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 Battery 420 FDA C54577 FDA Device Component Code Hierarchy C50034 Load 869 Any device that draws current from an electrical system. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50035 Lock 870 A fastening device designed to hold, close, or secure. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50286 Locking Mechanism 3083 A fastening device designed to hold, close, or secure. C50285 Mechanism 3085 FDA C54577 FDA Device Component Code Hierarchy C50036 Locking Sleeve 571 A cylindrical fitting that slides over a part and locks into place. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50287 Lockout Mechanism 3084 A device designed to prevent multiple, simultaneous connections to a system. C50285 Mechanism 3085 FDA C54577 FDA Device Component Code Hierarchy C50037 Logic Board 480 The circuit board that contains most of the processor units. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50038 Lower Piston Bearing 572 A bearing located toward the bottom of a piston. C49842 Bearings 734 FDA C54577 FDA Device Component Code Hierarchy C50260 Luer Valve 481 A valve that incorporates a Luer fitting. C50243 Valve 527 FDA C54577 FDA Device Component Code Hierarchy C50039 Magazine 871 A compartment in a device designed to house a consumable material for feeding into a mechanism. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50040 Magnet 482 A device that attracts iron and produces a magnetic field. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50041 Magnetizer 872 A device designed to make another object magnetic. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50053 Magnetometer 873 A device designed to measure the strength of a magnetic field. C50052 Gauges/Meters 462 FDA C54577 FDA Device Component Code Hierarchy C50042 Magnetoresistor 874 A variable resistor that can be controlled by a magnetic field. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50043 Magnifier 875 An optical device designed to enlarge an image. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50044 Manifold 483 A branched system of pipes, typically those that attach to an engine to carry away exhaust. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50045 Matrices 876 C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50285 Mechanism 3085 A device consisting of moving parts designed to perform a function. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50046 Membrane 484 A device that is made from or resembles a thin flexible sheet of material. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50047 Memory 877 Any device that can hold data in machine-readable format. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50082 Meter Needle 573 A needle-shaped part designed to indicate a position on a scale. C50290 Needle 3088 FDA C54577 FDA Device Component Code Hierarchy C50067 Microcircuit 879 An integrated circuit containing multiple components. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50068 Microphone 880 A device designed to convert sound to an electrical signal. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50069 Microscope 881 An optical instrument that uses a combination of lenses to produce magnified images of very small objects C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50070 Mirror 882 A device consisting of a polished surface designed to reflect light. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50071 Mixer 883 A mechanical device designed to blend materials or an electronic device designed to blend signals. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50072 Modem 884 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. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50073 Modulator 885 An electronic device designed to vary the frequency, amplitude, or phase of an electromagnetic signal. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50074 Monitor 886 A device than includes a sensor designed to give information about the presence of a substance or the state of a system. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50076 Motherboard 485 The circuit board that contains most of the processor units. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50355 Motion Detector 3086 A device designed to signal the presence of excess motion in a system. C49916 Detector 787 FDA C54577 FDA Device Component Code Hierarchy C50077 Motor 486 A device designed to convert energy into mechanical motion. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50331 Motor Drive Unit 3087 A device consisting of a motor and accessory parts designed to power a machine. C50329 Unit 3127 FDA C54577 FDA Device Component Code Hierarchy C50103 Motor Roll Pin 574 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 Pin 906 FDA C54577 FDA Device Component Code Hierarchy C50079 Mount 887 A structural device designed to facilitate the attachment of one object to another. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C54010 Multiplier 888 A device designed to take an input and increase some characteristic of it. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50080 Nebulizer (Only Use When Part Of Another Device) 889 A device designed to convert a liquid to a mist. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50290 Needle 3088 A device part with a long, slender, pointed shape. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50081 Network 890 A collection of two or more computers and associated devices that are linked together with communications equipment. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50083 None 1023 An indication that there is no device or component that matches the criteria. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50291 Nozzle 3092 A device designed to regulate and direct the flow of a fluid. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50325 Nozzle Tip 3093 A device designed to form the end of a nozzle. C50324 Tip 3123 FDA C54577 FDA Device Component Code Hierarchy C50084 Nuts 891 A threaded fastener designed to engage a bolt. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50085 O2 Monitor Subassembly (Only Use When Part Of Another Device) 487 A sensor and circuit designed to sense the oxygen level in a space, environment, or material, as part of a larger device. C53996 Device Subassembly 3051 FDA C54577 FDA Device Component Code Hierarchy C50168 O2 Sensor 892 A sensor designed to respond to the presence or level of oxygen in a space or environment. C50166 Sensor 510 FDA C54577 FDA Device Component Code Hierarchy C50086 Obturator 488 A plug-like device used to close an opening in a body structure or a removable plug used during the insertion of a cannula. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50334 One-Way Valve 3094 A valve designed to allow flow in only one direction. C50243 Valve 527 FDA C54577 FDA Device Component Code Hierarchy C49856 Optical Cable 894 A cable designed to use fiberoptic strands to transmit signals. C49855 Cable 423 FDA C54577 FDA Device Component Code Hierarchy C49926 Optical Disk 893 A data storage disk where the data is stored in a format to be read optically by a laser and receiver. C49925 Disk 791 FDA C54577 FDA Device Component Code Hierarchy C49954 Optical Fiber 546 A device made with thin glass fibers as a conduit for transmission of light. C49952 Fiber 814 FDA C54577 FDA Device Component Code Hierarchy C50087 Optocoupler 895 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. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50088 Oscillator 896 An electronic device designed to produce a wave signal. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50089 Oscilloscope 897 An electronic device designed to display electrical measurements, typically as a waveform on a cathode ray tube. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50091 Outlet 898 An opening in a device that allows something to exit, commonly used to refer to an electrical power receptacle. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50092 Oven 899 An enclosed structural device designed for heating an object. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50093 Overlay 575 A device designed to be applied over an object, typically for protection or identification. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50065 Oximeter (Only Use When Part Of Another Device) 490 Oximeter A device designed to measure oxygen saturation in arterial blood. C50052 Gauges/Meters 462 FDA C54577 FDA Device Component Code Hierarchy C50094 Oxygen Analyzer 491 A device designed to measure the concentration of oxygen in a gas mixture. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50095 Pad 900 A protective or cushioning material applied to a projecting or supporting surface of a device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50293 Pallet 3095 A device resembling a bed. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50096 Panel 901 A rigid sheet that forms a surface of a device or component. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50097 PC (Printed Circuit) Board 492 A circuit board that has connections that are preapplied, usually added using photo-resist and acid etching techniques. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49917 Photodetector 902 A device designed to detect light. C49916 Detector 787 FDA C54577 FDA Device Component Code Hierarchy C50098 Photomultiplier 903 An electronic sensing device designed to amplify low-energy light signals and convert them to electrical pulses. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50328 Photomultiplier (PM) Tube 3096 An electronic device designed to detect and amplify light signals. C50236 Tube 525 FDA C54577 FDA Device Component Code Hierarchy C50099 Phototransistor 904 A transistor in which incident light acts as the base activating input. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50100 Pickup 905 An electromagnetic device designed to convert movement to an electric signal. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50261 Pilot Balloon Valve 493 A two-way valve designed to control the pressure in an endotracheal tube cuff as introduced through a pilot balloon. C50243 Valve 527 FDA C54577 FDA Device Component Code Hierarchy C50101 Pin 906 A small, slender object designed to secure another object. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50296 Pipette 3097 A measuring device, traditionally including a graduated tube, designed for the accurate transfer of liquid volumes. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49975 Piston Guides 576 A device similar to a bushing but designed to reduce the linear friction between a piston and its cylinder. C49974 Guide 829 FDA C54577 FDA Device Component Code Hierarchy C49981 Piston Heads 577 The portion of a piston above the topmost seal ring. C49980 Heads 832 FDA C54577 FDA Device Component Code Hierarchy C50104 Piston Pads 578 A pad designed to fit onto the head of a piston. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50105 Pivot 494 A device designed to act as a center of rotation. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50106 Plate 907 A sheet of metal or wood or glass or plastic. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50107 Plotter 908 A computer driven instrument designed for drawing graphs and pictures. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50108 Plug 579 A device designed to seat into an opening in a device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50297 Plunger 3098 A mechanical device designed to slide within a chamber to transfer a material. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50109 Pointer 910 An indicator device designed to show a position on a scale. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50110 Polarizer 911 An optical device that creates polarized light from incident light. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50111 Port 495 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. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50112 Post 912 A structural device part that supports or aligns other parts. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50064 Potentiometer 496 A device designed to measure a direct current electromotive force or a device designed to control the current that flows through a circuit. C50052 Gauges/Meters 462 FDA C54577 FDA Device Component Code Hierarchy C49892 Power Cord 497 A flexible cable designed to connect an electric device to a power source. C49890 Cord 768 FDA C54577 FDA Device Component Code Hierarchy C50113 Power Lamp 580 A light designed to indicate the status of a power source or power connection. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50114 Power Module 913 An independent electronic device designed to supply power to other devices. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50115 Power Supply 498 Any electronic device designed to supply power to other devices. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50200 Power Switch 499 A switch designed to regulate the power to a device. C50199 Switches 519 FDA C54577 FDA Device Component Code Hierarchy C50116 Preamplifier 914 An electronic device designed to boost the signal of a low-level input signal to an intermediate level prior to further amplification. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50117 Prescaler 915 An electronic counter device designed to reduce a very high frequency signal to a lower frequency by division. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50118 Preselector 916 A preamplifier device that is designed to operate between an antenna and a receiver to improve reception. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50167 Pressure Sensor 500 A sensor designed to respond to the level of pressure in a space or pressing on a surface. C50166 Sensor 510 FDA C54577 FDA Device Component Code Hierarchy C50119 Pressure Signal 581 A device designed to monitor or display a pressure reading. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50239 Pressure Tubing 501 Flexible tubing designed to withstand high pressure. C50236 Tube 525 FDA C54577 FDA Device Component Code Hierarchy C50120 Printer 917 An electronic device that is designed to transfer text or images to paper or other substrate. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50121 Probe 918 A device designed to reach into a location for manipulating or sensing. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50299 Probe, Transducer Pressure 3099 A probe device designed to convert a change in pressure into a varying electrical signal. C50121 Probe 918 FDA C54577 FDA Device Component Code Hierarchy C50122 Processor 919 A device designed for preparing or treating a material; also the part of a computer that makes most of the calculations. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50123 Programmer 920 A device designed to write instructions to a memory device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50050 PROM (Programmable Read Only Memory) 503 A type of read only memory device that can be written to once after manufacture. C50048 ROM (Read Only Memory) 509 FDA C54577 FDA Device Component Code Hierarchy C50124 Prong 504 Any pointed projection on a device, usually one designed to attach a device to something else. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50125 Protector 921 A device or attachment designed to shield something from harm. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50203 Proximity Switch 922 A switch designed to actuate when something comes within a predetermined distance. C50199 Switches 519 FDA C54577 FDA Device Component Code Hierarchy C50126 Pulley 923 A wheel with a groove in it designed to change the direction of force of a rope or belt that runs over it. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50127 Pulser 924 A device designed to produce a short burst of signal. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50128 Pump 925 A device designed to facilitate the movement of a fluid. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C54023 Pusher 3157 A device designed to advance something by pushing it. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50063 Pyrometer 926 A device designed to measure high temperatures, such as those in a furnace. C50052 Gauges/Meters 462 FDA C54577 FDA Device Component Code Hierarchy C50130 Rail 927 A bar designed for support, attachment, guidance, or protection from falling. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50051 RAM (Random Access Memory) 505 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 Memory 877 FDA C54577 FDA Device Component Code Hierarchy C50303 Rate Modulated Pacing Sensor 3100 A sensor for a pacemaker designed to alter the rate of heart stimulation based on the activity level of the subject. C50166 Sensor 510 FDA C54577 FDA Device Component Code Hierarchy C50131 Reactor 928 A vessel in which a chemical reaction takes place or an electronic device designed to add reactance to a circuit. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50132 Reader 929 A device designed to capture data encoded on an object and convert it to a signal that can be input into a computer. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50133 Receiver 930 An electronic device designed to capture an incoming electromagnetic signal and convert it to an audible or visual signal. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50330 Receiver Stimulator Unit 3101 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 Unit 3127 FDA C54577 FDA Device Component Code Hierarchy C50134 Recorder (Tape, Stripchart, Etc.) 507 A device designed to capture and store audiovisual or other data. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50135 Rectifier 931 An electrical device designed to convert alternating current to direct current. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50136 Reed (Electrically Open) 582 A switch device consisting of thin, flexible, magnetically controlled contacts enclosed in a sealed and evacuated enclosure. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50137 Regulator 932 Any device designed to control a process or condition. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50138 Relay 508 An electrical circuit designed to act as a switch for another circuit. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50139 Repeater 933 An electronic device designed to receive a signal, amplify it, and resend it. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50140 Reservoir 934 A vessel designed to store a fluid. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50141 Resistor 935 An electronic device that opposes the flow of current. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50143 Resonator 937 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. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50144 Retainer 938 A physical device designed to hold something in place. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50102 Retaining Pin 583 A pin designed to fasten one object into another. C50101 Pin 906 FDA C54577 FDA Device Component Code Hierarchy C50145 Reticle 939 A grid or pattern in the eyepiece of an optical device designed to establish a scale or position reference. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50146 Rheostat 941 A mechanical device designed to create variable resistance in a circuit based on the position of a contact on a coil. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50147 Ribbon 942 Any device that consists of a long, narrow, flexible material. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50148 Ring 943 Any doughnut-shaped device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50151 Rivet 944 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. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50152 Robot 945 A mechanical device designed to perform an automated action. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50153 Rod 946 Any rod-shaped device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50048 ROM (Read Only Memory) 509 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 Memory 877 FDA C54577 FDA Device Component Code Hierarchy C50154 Safety Interlock 947 A mechanical or electronic device designed to prevent one action from happening when certain conditions exist. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50155 SAW (Surface Acoustic Wave Device) 984 An electronic device designed to propagate an acoustic wave along the surface of a piezoelectric substrate as a filter, oscillator, or transformer. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50156 Scale 949 A device designed for weighing or an indicator device with a graduated sequence of divisions. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50157 Scaler 948 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. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50158 Scanner 950 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. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50062 Scintillometer 951 A device designed to measure radioactivity indirectly by its ability to cause flashes of light in a sensitive material. C50052 Gauges/Meters 462 FDA C54577 FDA Device Component Code Hierarchy C50159 Scrambler 952 An electronic device or software designed to transmit a telecommunications signal so that it is unintelligible but can be restored at the receiver. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50160 Screen 953 An electronic device designed as a display or a physical device designed to be a protective meshwork. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50161 Screw 568 A fastener device with a tapered threaded shaft and a head designed to engage a drive device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50278 Screw Head 3102 The end of a screw designed to interact with a drive device. C49980 Heads 832 FDA C54577 FDA Device Component Code Hierarchy C50321 Screw Tapper 3103 A device designed to cut threads in a object C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50162 Scriber 954 A pointed device designed to etch a mark on an object. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50163 Seal 432 A device designed to prevent passage of some material through a joint or opening. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50164 Seal Tracheal 584 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 Seal 432 FDA C54577 FDA Device Component Code Hierarchy C50360 Sediment Filter 3104 A filter designed to remove particles from a liquid. C49956 Filter 816 FDA C54577 FDA Device Component Code Hierarchy C50166 Sensor 510 A device designed to respond to a stimulus by generating a signal that can be measured or interpreted. C50121 Probe 918 FDA C54577 FDA Device Component Code Hierarchy C50169 Servo 551 An electronic device designed to amplify the force of a movement. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50170 Shaft 955 A long rod. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50171 Shield 956 A device designed to form a protective covering or structure. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50172 Shift Register 957 An electronic circuit designed to move all data to the left or right, thereby doing multiplication, division, or parallel conversion. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50173 Shifter 958 A mechanical device designed to change the gears in a mechanism. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C76120 Shock Capacitor 3105 The component of a defibrillator designed to store the electrical charge before it is delivered to the patient. C49862 Capacitor 555 FDA C54577 FDA Device Component Code Hierarchy C50305 Shoulder Support 3106 A device designed to support an object as it sits on the shoulder or an orthopedic device designed for rehabilitation after a shoulder injury. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50174 Shunt 959 An implantable device designed to drain fluid from a body cavity. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50175 Shutter 960 A mechanical or electronic device designed to regulate an exposure time, especially the one in a camera. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50301 Side Rail 3107 A supportive or protective rail attached to the side of something. C50130 Rail 927 FDA C54577 FDA Device Component Code Hierarchy C50176 Signal Conditioner 961 An electronic device or circuit designed to take an input signal and offset, attenuate, amplify, and/or filter the output signal. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50177 Simulator 962 A device designed to create a test or training environment that approximates actual conditions. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50178 Slide 963 A flat rectangular piece of glass on which specimens can be mounted for microscopic study. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50149 Slip Ring 964 A ring-shaped electrical contact designed to provide connection to a rotating part. C50148 Ring 943 FDA C54577 FDA Device Component Code Hierarchy C50179 Slotter Line 965 A device designed to make a longitudinal cut through the protective cladding of a fiber bundle without harming the fibers. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50180 Socket 967 A device designed as an opening into which something else fits. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49809 Socket Adaptor 966 A device designed to allow an incompatible plug to connect with another device. C49808 Adapter (Adaptor) 431 FDA C54577 FDA Device Component Code Hierarchy C50014 Solder Joint 511 A connection between objects formed by solder. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50181 Solenoid 512 An electronic device consisting of a coil surrounding a movable iron core that is designed to act as a switch or relay. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49805 Sound Absorber 968 A device or material designed to attenuate sound energy. C50372 Absorber 3028 FDA C54577 FDA Device Component Code Hierarchy C50182 Spacer 969 A device designed to position objects further apart. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50183 Spark Gap 970 An electronic device consisting of electrical contacts separated by a gap across which a spark will form when the voltage is high enough. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50184 Speaker 971 A device designed to convert electrical signals to sounds that can be heard. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50061 Spectrometer 972 A device designed to measure wave lengths and angles of deflection of an electromagnetic radiation source, generating a spectrum plot across frequencies. C50052 Gauges/Meters 462 FDA C54577 FDA Device Component Code Hierarchy C50306 Speech Processor 3108 An electronic device designed to convert speech sounds into electrical signals, especially as part of a cochlear implant. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50066 Spirometer 514 A device designed to measure lung capacity. C50052 Gauges/Meters 462 FDA C54577 FDA Device Component Code Hierarchy C50185 Splicer 973 A device designed to join pieces of a material into a continuous length. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50186 Spooler 974 An electronic device designed to set files into a queue for processing, especially one for controlling the output to a printer. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50187 Spring 975 An elastic device designed to bend under a load and then return to its shape when unloaded. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50288 Spring Loading Mechanism 3109 A device that uses a spring to deliver something into a device or system. C50285 Mechanism 3085 FDA C54577 FDA Device Component Code Hierarchy C50188 Stabilizer 976 A device designed to reduce unwanted movement. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50189 Stand 977 A support device designed to hold an object. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50307 Staple 3110 A fastening device consisting of a bent wire designed to pierce and hold. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50337 Steering Wire 3111 A wire designed to connect to a steering device. C50269 Wire 430 FDA C54577 FDA Device Component Code Hierarchy C50190 Stent 515 A device designed to support a tubular structure, especially the small stainless steel expandable mesh tube inserted within an artery. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50078 Stepper Motor 516 A motor designed to rotate in fixed increments. C50077 Motor 486 FDA C54577 FDA Device Component Code Hierarchy C50191 Stiffener 978 A material or device designed to stiffen an object. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50192 Stopcock 517 A rotating device designed to act like a faucet for regulating the flow of a fluid. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50333 Stopcock Valve 3112 A rotating valve designed to regulate the flow of a fluid through a stopcock. C50243 Valve 527 FDA C54577 FDA Device Component Code Hierarchy C50193 Strain Relief 979 A structure designed to function with a connector to prevent damage to a hose or cable from excess flexing. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50194 Strip Line 980 A conductor cable designed as a thin, flexible ribbon of metals separated by an insulating layer. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50195 Stylet 518 A thin metal wire designed to be passed through a needle, catheter, or cannula to stiffen it or clear it of debris. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50196 Substrate 981 C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50197 Sunlamp 982 A lamp designed to emit ultraviolet radiation. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50198 Suppressor 983 An electrical device designed to reduce or eliminate unwanted currents. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50364 Surgical Graft 3113 A tissue or organ surgically moved from a donor to a recipient or from site to site of an individual. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50365 Suture 3114 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. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C54013 Switch, Push Button 3154 A switch designed to be operated by pressing a button. C50199 Switches 519 FDA C54577 FDA Device Component Code Hierarchy C50199 Switches 519 A mechanical or electronic device designed to break or change the connections in a circuit. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50205 Synchronizer 985 A mechanical device on a transmission designed to make the gears spin at the same speed. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50206 Synthesizer 986 C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50207 Syringe 987 A device designed as a rigid cylinder with a plunger at one end and a delivery opening at the other. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50310 Syringe Drive 3115 A device designed to advance a syringe plunger at a specified rate, used to administer continuous subcutaneous infusions. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50311 System 3116 A group of independent but interrelated devices working together. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50371 Table 3117 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. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50320 Table Top 3118 The uppermost, flat surface of a table. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50060 Tachometer 989 A device designed to measure a speed of rotation. C50052 Gauges/Meters 462 FDA C54577 FDA Device Component Code Hierarchy C50209 Tape 990 A long, thin, flat, flexible material often used for measuring, binding or fastening, or as a recording medium. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50210 Tee 991 A device designed to be used for transesophogeal echocardiogram (TEE). C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50211 Telemetry Equipment 520 Equipment designed to transmit and receive data from a remote source using telecommunications methods. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50212 Telephone 992 Electronic equipment that converts sound into electrical signals that can be transmitted over distances and then converts received signals back into sounds. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50213 Teleprinter 993 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. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50214 Teletypewriter 994 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. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50242 Television Unit 995 An electrical device designed to receive a television signal and display an image. C50329 Unit 3127 FDA C54577 FDA Device Component Code Hierarchy C50215 Temperature Compensator 996 A device designed to vary the temperature of one system in response to temperature changes in another system or the environment. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50300 Temperature Probe 3119 A remote sensor designed to respond to the temperature of a space, surface, or environment. C50121 Probe 918 FDA C54577 FDA Device Component Code Hierarchy C50304 Temperature Sensor 3120 A sensor designed to respond to the temperature of a space, surface, or environment. C50166 Sensor 510 FDA C54577 FDA Device Component Code Hierarchy C50216 Terminal 997 An electronic device designed to provide access to a computer. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50217 Terminal Assembly 585 A part of a device that includes a terminal as part of a larger device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50218 Terminator 998 A device designed to connect to the end of a bus network. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50322 Test Strip 3121 A piece of chemically treated medium designed to react in the presence of specific amounts of a trigger substance. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50219 Thermistor 999 A type of resistor designed from materials whose resistance varies as a function of temperature. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50220 Thermocouple 1000 A device designed for temperature acquisition consisting of two wires of different metals that are joined at both ends. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50270 Thermocouple Wire 547 A wire designed for temperature acquisition as part of a thermocouple. C50269 Wire 430 FDA C54577 FDA Device Component Code Hierarchy C50059 Thermometer 3158 A device designed to measure temperature. C50052 Gauges/Meters 462 FDA C54577 FDA Device Component Code Hierarchy C50221 Thermostat 3159 A device designed to regulate temperature by controlling the starting and stopping of a heating/cooling system. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50323 Thread 3122 A fine cord typically used for sewing. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50222 Thyristor 3135 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. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50223 Timer 3136 A device designed to measure a time interval. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50324 Tip 3123 The extreme end of something, especially something pointed. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49879 Tip Conductor Coil 586 A coil associated with a tip conductor voltage tester. C49877 Coil 761 FDA C54577 FDA Device Component Code Hierarchy C50294 Tomographic Pallet 3124 The part of a tomography machine on which the subject lays. C50293 Pallet 3095 FDA C54577 FDA Device Component Code Hierarchy C50350 T-Piece Connector 3125 A device, usually for connecting tubing, that resembles the letter T. C49885 Connector 435 FDA C54577 FDA Device Component Code Hierarchy C50224 Trackball 3137 An electronic pointing device that incorporates a rotatable ball designed to detect motion of the ball in two dimensions. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50225 Transceiver 3138 An electronic device designed to be both a transmitter and a receiver. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50226 Transducer 522 An electrical device that converts one form of energy into another. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50227 Transformer 523 A device that either steps up or steps down an alternating electrical current to an output that is suitable for another electrical device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50228 Transistor 524 A semiconductor component with three terminals that is designed to amplify a signal. It is the fundamental component of all modern circuitry. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50229 Translator 3139 A device designed to convert computer code or signals from one type to another. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50230 Transmission Line 3140 A conductor designed to transfer power or signal from one location to another. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50231 Transmitter 3141 A device to propagate electromagnetic waves. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50232 Transponder 3142 An electrical device designed to send a specific response upon receiving a specific signal. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50233 Transport 3143 Any device designed to move something. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50234 Triac 3144 Three Terminal Current Controlling Semiconductor A bidirectional thyristor designed to control AC power. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50235 Trimmer 3145 A capacitor having variable capacitance or a device designed to cut something to size. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50327 Trocar 3126 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. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50236 Tube 525 Any device or component shaped like a hollow cylinder. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50237 Tube Capillary 587 A tube with a narrow diameter designed to hold a liquid by capillary action. C50236 Tube 525 FDA C54577 FDA Device Component Code Hierarchy C50240 Tuner 3146 An electronic receiver designed to capture signals of a selected frequency for amplification. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50329 Unit 3127 A largely self-contained device designed to be incorporated into a larger device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C54008 User Interface 444 A computer program that controls the interaction between a user and a system. C50008 Interface 848 FDA C54577 FDA Device Component Code Hierarchy C50243 Valve 527 Valve (One-Way, Hemo, Stopcock, Etc.) A mechanical device designed to control the flow of a fluid. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C54016 Valve Cam 3155 A rotating disk attached to a shaft designed to control the opening and closing of a valve. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50244 Valve, Control 529 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 Valve 527 FDA C54577 FDA Device Component Code Hierarchy C50245 Valve, Directional 530 A valve designed to control the flow of fluid in a hydraulic system. C50243 Valve 527 FDA C54577 FDA Device Component Code Hierarchy C50246 Valve, Dump 589 A outflow valve designed to quickly empty a system. C50243 Valve 527 FDA C54577 FDA Device Component Code Hierarchy C50247 Valve, Exhalation 531 A valve designed to allow the escape of exhaled gases from a respirator or respiration system. C50243 Valve 527 FDA C54577 FDA Device Component Code Hierarchy C50248 Valve, Flap 532 A valve that is hinged on one edge. C50243 Valve 527 FDA C54577 FDA Device Component Code Hierarchy C50249 Valve, Flow 533 A valve designed to regulate the flow of fluid, especially one designed to prevent flow when a certain flow rate is exceeded. C50243 Valve 527 FDA C54577 FDA Device Component Code Hierarchy C50250 Valve, Inhalation 534 A valve designed to regulate the flow of gases into a respirator or respiration system. C50243 Valve 527 FDA C54577 FDA Device Component Code Hierarchy C50251 Valve, Inlet Port 535 A valve that controls the flow of fluids in through the wall of a chamber. C50243 Valve 527 FDA C54577 FDA Device Component Code Hierarchy C50252 Valve, Inspiratory 536 A valve designed to regulate the flow of gases into a respirator or respiration system. C50243 Valve 527 FDA C54577 FDA Device Component Code Hierarchy C50253 Valve, Outlet Port 537 A valve designed to control the flow of fluids out through the wall of a chamber. C50243 Valve 527 FDA C54577 FDA Device Component Code Hierarchy C50254 Valve, PEEP (Positive End Expiratory Pressure) 538 A valve designed to work on a positive airway pressure device to maintain the positive pressure at the end of the respiratory cycle. C50243 Valve 527 FDA C54577 FDA Device Component Code Hierarchy C50255 Valve, Pressure Limit 539 A valve designed to automatically open in order to maintain the pressure in a system below a specified pressure. C50243 Valve 527 FDA C54577 FDA Device Component Code Hierarchy C50256 Valve, Relief 540 A valve designed to automatically open in order to maintain the pressure in a system below a specified pressure. C50243 Valve 527 FDA C54577 FDA Device Component Code Hierarchy C50257 Valve, Safety 541 A valve designed to automatically open in order to maintain the pressure in a system below a specified pressure. C50243 Valve 527 FDA C54577 FDA Device Component Code Hierarchy C50258 Valve, Selector 542 A valve designed to control which of several ports will be connected to a system. C50243 Valve 527 FDA C54577 FDA Device Component Code Hierarchy C50262 Vaporizer 543 A device designed to convert a solution to an aerosol or mist, especially one to prepare a medication for inhaling. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50263 Varistor 3147 A semiconductor resistor device designed to have a voltage-dependent nonlinear resistance where resistance drops as the applied voltage increases. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50264 VDT (Video Display Terminal) 588 A device incorporating a cathode ray tube, a keyboard and a computer connection designed to render data from a computer system. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50265 Vibrator 3148 A mechanical device designed to create a vibratory motion. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50266 Viewer 3149 C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50058 Voltmeter 1018 A device designed to measure the voltage potential difference between points in a circuit. C50052 Gauges/Meters 462 FDA C54577 FDA Device Component Code Hierarchy C50267 Washer 3150 A device designed to cleanse an object, or a flattened disk used as a mechanical seal between objects. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50315 Water Purification System 3128 A system designed to remove unwanted substances from water. C50311 System 3116 FDA C54577 FDA Device Component Code Hierarchy C49976 Waveguide 3151 A material and device designed to guide and shape an electromagnetic wave. C49974 Guide 829 FDA C54577 FDA Device Component Code Hierarchy C50361 Wedge Filter 3129 A filter designed so that its thickness or transmission properties increase from one edge to another. C49956 Filter 816 FDA C54577 FDA Device Component Code Hierarchy C89532 Weld 3195 Any joining connection that is the result of welding 2 or more parts. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C51067 Wheel 3130 A mechanical device consisting of a spoked, circular rim or solid disk designed to rotate on an axle or shaft. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C51069 Wheelchair, Tires 3131 A tire designed to be mounted on a wheelchair wheel. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C51068 Wheelchair, Wheels 3132 A wheel designed to be used on a wheelchair. C51067 Wheel 3130 FDA C54577 FDA Device Component Code Hierarchy C50268 Window 3152 A transparent panel in a device designed for visual inspection. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50269 Wire 430 A metal strand designed for signal or power transmission or for structural or other purpose. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50272 Wiring Harness 544 A collection of grouped wires or cables designed to connect to a specific device. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C50273 Yoke 3153 A structural device designed to connect multiple objects. C54577 FDA Device Component Code Hierarchy FDA C54577 FDA Device Component Code Hierarchy C49886 Y-Piece Connector 545 A device, usually for connecting tubing, that resembles the letter Y. C49885 Connector 435 FDA C54451 FDA Device Problem Code Hierarchy C63281 Aborted Charge 2288 IMDRF:A070601 Charge, Aborted Problem associated with the premature ending of the charging process (e.g. of a battery or other charge storage device). Problem associated with the premature ending of the charging process (e.g. of a battery or other charge storage device). C63026 Charging Problem 2892 FDA C54451 FDA Device Problem Code Hierarchy C63036 Accessory Incompatible 1004 IMDRF:A170101 Accessories, Incompatible An accessory required for the intended purpose of the device appears incompatible with device, thus compromising the intended function of the device. An accessory required for the intended purpose of the device appears incompatible with device, thus compromising the intended function of the device. C63020 Component or Accessory Incompatibility 2897 FDA C54451 FDA Device Problem Code Hierarchy C96715 Activation Failure Including Expansion Failures 3270 IMDRF:A150101 Problem associated with the device failing to be activated including expansion. Problem associated with the device failing to be activated including expansion. C133631 Activation Problem 4042 FDA C54451 FDA Device Problem Code Hierarchy C133631 Activation Problem 4042 IMDRF:A1501 Problem associated with the activation of the device. Problem associated with the activation of a device. C63013 Activation, Positioning or Separation Problem 2906 FDA C54451 FDA Device Problem Code Hierarchy C63013 Activation, Positioning or Separation Problem 2906 IMDRF:A15 Problem associated with any deviations from the documented specifications of the device that relate to the sequence of events for activation, positioning or separation of device. NOTE: "Deployment" is synonymous with "activation". Problem associated with any deviations from the documented specifications of a medical device that relate to the sequence of events for activation, positioning or separation of device. C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C76126 Adverse Event Without Identified Device or Use Problem 2993 IMDRF:A24 An adverse event (e.g. patient harm) appears to have occurred, but there does not appear to have been a problem with the device or the way it was used. An adverse event appears to have occurred, but there does not appear to have been a problem with a medical device or the way it was used. C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C63309 Alarm Not Visible 1022 IMDRF:A160101 The device does not display an alarm message when required. A device does not display an alarm message when required. C63033 Device Alarm System 1012 FDA C54451 FDA Device Problem Code Hierarchy C63308 Ambient Noise Problem 2877 IMDRF:A1901 Problem associated with any undesired acoustic energy or vibration that tends to interfere with the operation of the device. Problem associated with any undesired acoustic energy or vibration that tends to interfere with the operation of the device. C63209 Environmental Compatibility Problem 2929 FDA C54451 FDA Device Problem Code Hierarchy C63307 Ambient Temperature Problem 2878 IMDRF:A1902 Problem associated with compromised device performance at the ambient temperature or the storage at an inappropriate ambient temperature. Problem associated with compromised device performance at the ambient temperature or the storage at an inappropriate ambient temperature. C63209 Environmental Compatibility Problem 2929 FDA C54451 FDA Device Problem Code Hierarchy C64349 Application Network Problem 2879 IMDRF:A1101 Problem associated with the deviations from documented system specifications that affects overall system performance and/or the performance of an individual device connected to that system. Problem associated with the deviations from documented system specifications that affects overall system performance and/or the performance of an individual medical device connected to that system. C63269 Computer Software Problem 1112 FDA C54451 FDA Device Problem Code Hierarchy C133578 Application Program Freezes, Becomes Nonfunctional 4031 IMDRF:A110201 Problem associated with freezing and becoming nonfunctional of an application program. Problem associated with freezing and becoming nonfunctional of an application program. C63305 Application Program Problem 2880 FDA C54451 FDA Device Problem Code Hierarchy C63305 Application Program Problem 2880 IMDRF:A1102 Problem associated with the requirement for software to fulfill its function within an intended use or application. Problem associated with the requirement for software to fulfill its function within an intended use or application. C63269 Computer Software Problem 1112 FDA C54451 FDA Device Problem Code Hierarchy C63220 Application Program Problem: Dose Calculation Error 1189 IMDRF:A110202 Dose Calculation Error Problem associated with the written program code or application software used by the device to calculate specific measurements or quantities managed by the device. Problem associated with the written program code or application software used by a device to calculate specific measurements or quantities managed by the device. C63305 Application Program Problem 2880 FDA C54451 FDA Device Problem Code Hierarchy C91396 Application Program Problem: Medication Error 3198 IMDRF:A110203 Event in which the device software results in errors of medication preparation or administration. An error in medication preparation or administration attributed to software. C63305 Application Program Problem 2880 FDA C54451 FDA Device Problem Code Hierarchy C63083 Application Program Problem: Parameter Calculation Error 1449 IMDRF:A110204 Parameter Calculations, Incorrect Problem associated with the written program code or application software used by the device to calculate parameters other than those related to dose or power. Problem associated with the written program code or application software used by a device to calculate parameters other than those related to dose or power. C63305 Application Program Problem 2880 FDA C54451 FDA Device Problem Code Hierarchy C62916 Application Program Problem: Power Calculation Error 1473 IMDRF:A110205 Power, Miscalculation Of Problem associated with the written program code or application software used by the device for calculations related to device power. Problem associated with the written program code or application software used by a device for calculations related to device power. C63305 Application Program Problem 2880 FDA C54451 FDA Device Problem Code Hierarchy C63304 Application Program Version or Upgrade Problem 2881 IMDRF:A110206 Problem associated with installing updates to a software system that affects the device performance or communication with another device. Problem associated with installing updates to a software system that affects a device performance or communication with another device. C63305 Application Program Problem 2880 FDA C54451 FDA Device Problem Code Hierarchy C63042 Application Security Problem 2882 IMDRF:A110501 Computer Virus Infection Problem 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. Problem 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. C64348 Computer System Security Problem 2899 FDA C54451 FDA Device Problem Code Hierarchy C64343 Appropriate Term/Code Not Available 3191 IMDRF:A27 The device problem is not adequately described by any other term. Note: this code must not be used unless there is no other feasible code. The preferred term should be documented when submitting an adverse event report. This information will be used to determine if a new term should be added to the code table. A device problem is not adequately described by any other term. Note: this code must not be used unless there is no other feasible code. C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C63301 Arcing 2583 IMDRF:A0703 Problem associated with electrical current flowing through a gap between two conductive surfaces, typically resulting in a visible flash of light. Problem associated with electrical current flowing through a gap between two conductive surfaces, typically resulting in a visible flash of light. C63007 Electrical /Electronic Property Problem 1198 FDA C54451 FDA Device Problem Code Hierarchy C63302 Arcing at Paddles 1032 IMDRF:A070301 Problem associated with electrical current flowing through a gap between paddles (conductive surfaces), typically resulting in a visible flash of light. Problem associated with electrical current flowing through a gap between paddles (conductive surfaces), typically resulting in a visible flash of light. C63301 Arcing 2583 FDA C54451 FDA Device Problem Code Hierarchy C63303 Arcing of Electrodes 2289 IMDRF:A070302 Problem associated with electrical current flowing through a gap between electrodes (conductive surfaces), typically resulting in a visible flash of light. Problem associated with electrical current flowing through a gap between electrodes (conductive surfaces), typically resulting in a visible flash of light. C63301 Arcing 2583 FDA C54451 FDA Device Problem Code Hierarchy C133545 Audible Prompt / Feedback 4020 IMDRF:A0901 Problem with any deviation from the documented specifications of the device that relate to audible feedback. e.g. voice prompts or beeps, but not safety related alarms which are covered under "Protective Measures Problem". Problem with any deviation from the documented specifications of a device that relates to audible feedback. C62941 Output Problem 3005 FDA C54451 FDA Device Problem Code Hierarchy C63290 Backflow 1064 IMDRF:A140501 Continuous flow of fluid (e.g. liquid, gas) against the intended flow direction. Continuous flow of fluid (e.g. liquid, gas) against the intended flow direction. C63110 Improper Flow or Infusion 2954 FDA C54451 FDA Device Problem Code Hierarchy C63030 Battery Problem 2885 IMDRF:A0705 Problem associated with the internal power of the device (e.g. battery, transformer, fuel cell or other power sources). Problem associated with the internal power of a device (e.g. battery, transformer, fuel cell or other power sources). C63007 Electrical /Electronic Property Problem 1198 FDA C54451 FDA Device Problem Code Hierarchy C64336 Battery Problem: High Impedance 2947 IMDRF:A070501 Problem related to increased battery internal impedance. Problem related to increased battery internal impedance. C63030 Battery Problem 2885 FDA C54451 FDA Device Problem Code Hierarchy C64335 Battery Problem: Low Impedance 2973 IMDRF:A070502 Problem related to decreased battery internal impedance. Problem related to decreased battery internal impedance. C63030 Battery Problem 2885 FDA C54451 FDA Device Problem Code Hierarchy C63294 Biocompatibility 2886 IMDRF:A010101 Problem associated with undesirable local or systemic effects due to exposure to medical device materials or leachates from those materials by a patient who has an implant or is receiving treatment with a device made from them. Problem associated with undesirable local or systemic effects due to exposure to device materials or leachates from those materials by a patient who has an implant or is receiving treatment with a device made from them. C62919 Patient-Device Incompatibility 2682 FDA C54451 FDA Device Problem Code Hierarchy C63293 Biofilm coating in Device 1062 IMDRF:A180101 Biofilm Coating Problem associated with the undesired introduction of a biofilm coating into or onto the device. Problem associated with the undesired introduction of a biofilm coating into or onto the device. C63018 Contamination During Use 1120 FDA C54451 FDA Device Problem Code Hierarchy C63288 Blocked Connection 2888 IMDRF:A1201 Problem associated with linking of the device whereby their functional units set up to provide means for a transfer of fluid, gas, or data is prevented or impeded. Problem associated with linking of a device whereby their functional units set up to provide means for a transfer of fluid, gas, or data is prevented or impeded. C62952 Connection Problem 2900 FDA C54451 FDA Device Problem Code Hierarchy C62973 Break 1069 IMDRF:A0401 Device Breakage|Material Break Problem associated with undesired damage or breakage of those materials used in the device construction. Problem associated with undesired damage or breakage of those materials used in the device construction. C62968 Material Integrity Problem 2978 FDA C54451 FDA Device Problem Code Hierarchy C62972 Burst Container or Vessel 1074 IMDRF:A0402 Material Burst Problem associated with the pressure inside a vessel or container rising to such a degree that the container ruptures. Problem associated with the pressure inside a vessel or container rising to such a degree that the container ruptures. C62968 Material Integrity Problem 2978 FDA C54451 FDA Device Problem Code Hierarchy C63285 Calcified 1077 IMDRF:A040501 Calcification|Calcified Material Problem associated with buildup of calcium salts on the device. Problem associated with buildup of calcium salts on a device. C62970 Degraded 1153 FDA C54451 FDA Device Problem Code Hierarchy C63028 Calibration Problem 2890 IMDRF:A08 Problem associated with the operation of the device, related to its accuracy, and associated with the calibration of the device. Problem associated with the operation of a device, related to its accuracy, and associated with the calibration of the device. C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C63283 Capacitative Coupling 1079 IMDRF:A072101 Problem associated with the transfer of energy within an electrical network by means of the capacitance between circuit nodes. It occurs when energy is coupled from one circuit to another through an electric field. Problem associated with the transfer of energy within an electrical network by means of the capacitance between circuit nodes. It occurs when energy is coupled from one circuit to another through an electric field. C63277 Circuit Failure 1089 FDA C54451 FDA Device Problem Code Hierarchy C63027 Capturing Problem 2891 IMDRF:A0701 Problem associated with the inability of the device to achieve successful depolarization and contraction of a cardiac chamber caused by a pacemaker output pulse. Problem associated with the inability of the device to achieve successful depolarization and contraction of a cardiac chamber caused by a pacemaker output pulse. C63007 Electrical /Electronic Property Problem 1198 FDA C54451 FDA Device Problem Code Hierarchy C63026 Charging Problem 2892 IMDRF:A0706 Problem associated with the inability of the device to successfully charge an electrical source. Problem associated with the inability of a device to successfully charge an electrical source. C63007 Electrical /Electronic Property Problem 1198 FDA C54451 FDA Device Problem Code Hierarchy C62945 Chemical Problem 2893 IMDRF:A03 Problem associated with any from the documented specifications of the device that relate to any chemical characterization, i.e., element, compound, or mixture. Problem associated with any from the documented specifications of a device that relate to any chemical characterization, i.e., element, compound, or mixture. C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C63277 Circuit Failure 1089 IMDRF:A0721 Problem associated with a failure of the internal network paths or electrical circuitry (i.e. electrical components, circuit boards, wiring). Problem associated with a failure of the internal network paths or electrical circuitry (i.e. electrical components, circuit boards, wiring). C63007 Electrical /Electronic Property Problem 1198 FDA C54451 FDA Device Problem Code Hierarchy C63275 Clumping in Device or Device Ingredient 1095 IMDRF:A030201 Clumping Problem associated with the aggregation of particles into irregular masses. Problem associated with the aggregation of particles into irregular masses. C62982 Device Ingredient or Reagent Problem 2910 FDA C54451 FDA Device Problem Code Hierarchy C63274 Coagulation in Device or device Ingredient 1096 IMDRF:A030202 Coagulation Problem associated with the undesired characterization of congealing, solidifying, thickening, curdling. Problem associated with the undesired characterization of congealing, solidifying, thickening, curdling. C62982 Device Ingredient or Reagent Problem 2910 FDA C54451 FDA Device Problem Code Hierarchy C63272 Collapse 1099 IMDRF:A051101 Problem associated with the buckling or crushing of material from external forces. Problem associated with the buckling or crushing of material from external forces. C62923 Structural Problem 2506 FDA C54451 FDA Device Problem Code Hierarchy C63271 Communication or Transmission Problem 2896 IMDRF:A13 Problem associated with the device sending or receiving signals or data. This includes transmission among internal components of the device to which the device is intended to communicate. Problem associated with a device sending or receiving signals or data. This includes transmission among internal components of the device to which the device is intended to communicate. C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C62983 Compatibility Problem 2960 IMDRF:A17 Compatibility Problem associated with compatibility between device, patients or substances (medication, body fluid, etc.) Problem associated with compatibility between device, patients or substances (medication, body fluid, etc.). C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C63024 Complete Blockage 1094 IMDRF:A140901 Clogged Problem related to an obstruction or blockage within the device component (e.g. tube, opening, pipe) that results in no flow. Problem related to an obstruction or blockage within the device component (e.g. tube, opening, pipe) that results in no flow. C62897 Obstruction of Flow 2423 FDA C54451 FDA Device Problem Code Hierarchy C133517 Complete Loss of power 4015 IMDRF:A070801 Problem associated with the lack of power to run the device. Problem associated with the lack of power to run a device. C63025 Power Problem 3010 FDA C54451 FDA Device Problem Code Hierarchy C63022 Component Incompatible 1108 IMDRF:A170102 Component(s), Incompatible A component required for the proper functioning of the device is not compatible with other components or subassemblies of the device, thus compromising the intended function of the device. A component required for the proper functioning of a device is not compatible with other components or subassemblies of a device, thus compromising the intended function of a device. C63020 Component or Accessory Incompatibility 2897 FDA C54451 FDA Device Problem Code Hierarchy C133498 Component Misassembled 4004 IMDRF:A020601 A device found to have one or more components incorrectly assembled when delivered to the user facility. A device is found to have one or more components incorrectly assembled when delivered to the user facility. C62957 Device Misassembled During Manufacturing / Shipping 2912 FDA C54451 FDA Device Problem Code Hierarchy C63021 Component Missing 2306 IMDRF:A020602 Components, Missing A device component(s) found to be missing when delivered to the user facility. A device component(s) found to be missing when delivered to the user facility. C62957 Device Misassembled During Manufacturing / Shipping 2912 FDA C54451 FDA Device Problem Code Hierarchy C63020 Component or Accessory Incompatibility 2897 IMDRF:A1701 Problem associated with the incompatibility of any device while being operated in the same use environment thereby leading to a dysfunction between the devices. Problem associated with the incompatibility of any device while being operated in the same use environment thereby leading to a dysfunction between the devices. C62983 Compatibility Problem 2960 FDA C54451 FDA Device Problem Code Hierarchy C63270 Computer Operating System Problem 2898 IMDRF:A1104 Problem associated with software, firmware, and/or 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. Problem associated with software, firmware, and/or 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 Computer Software Problem 1112 FDA C54451 FDA Device Problem Code Hierarchy C63269 Computer Software Problem 1112 IMDRF:A11 Computer Software Error Problem associated with written programs, codes, and/or software system that affects device performance or communication with another device. Issue associated with written programs, codes, and/or software system that affects device performance or communication with another device. C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C64348 Computer System Security Problem 2899 IMDRF:A1105 Problem associated with unauthorized access to or modification of a software system resulting in a loss of confidentiality, integrity, or availability of written program code, application software, or data or entire device. Problem associated with unauthorized access to or modification of a software system resulting in a loss of confidentiality, integrity, or availability of written program code, application software, or data or entire device. C63269 Computer Software Problem 1112 FDA C54451 FDA Device Problem Code Hierarchy C62952 Connection Problem 2900 IMDRF:A12 Problem associated with linking of the device and/or the functional units set up to provide means for a transfer of liquid, gas, electricity or data. Problem associated with linking of a device and/or the functional units set up to provide means for a transfer of liquid, gas, electricity or data. C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C63276 Contamination / decontamination Problem 2895 IMDRF:A18 Problem associated with the presence of any unexpected foreign substance found in the device, on its surface or in the package materials, which may affect performance or intended use of the device, or problem that compromise effective decontamination of the device. Problem associated with the presence of any unexpected foreign substance found in a device, on its surface or in the package materials, which may affect performance or intended use of the device, or problem that compromise effective decontamination of the device. C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C63018 Contamination During Use 1120 IMDRF:A1801 Contamination Problem 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. Problem associated with the undesired introduction of impurities either chemical or microbiological in nature, or of foreign matter into or onto a device at the user facility. C63276 Contamination / decontamination Problem 2895 FDA C54451 FDA Device Problem Code Hierarchy C63266 Contamination of Device Ingredient or Reagent 2901 IMDRF:A180102 Problem associated with the undesired introduction of impurities either chemical or microbiological in nature, or of foreign matter into or onto the device ingredient or reagent. Problem associated with the undesired introduction of impurities either chemical or microbiological in nature, or of foreign matter into or onto the device ingredient or reagent. C63018 Contamination During Use 1120 FDA C54451 FDA Device Problem Code Hierarchy C63265 Continuous Firing 1123 IMDRF:A0702 Problem associated with the excessive production of electrical impulses over a period. Problem associated with the excessive production of electrical impulses over a period. C63007 Electrical /Electronic Property Problem 1198 FDA C54451 FDA Device Problem Code Hierarchy C63263 Corroded 1131 IMDRF:A040502 Corrode Problem 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. Problem 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 Degraded 1153 FDA C54451 FDA Device Problem Code Hierarchy C62971 Crack 1135 IMDRF:A0404 Crack(s)|Material Crack Problem associated with an undesired partial separation and/or a visible opening along the length or width in the materials that are used in the device construction. Problem associated with an undesired partial separation and/or a visible opening along the length or width in the materials that are used in the device construction. C62968 Material Integrity Problem 2978 FDA C54451 FDA Device Problem Code Hierarchy C63261 Cross Reactivity 1137 IMDRF:A030204 Problem associated with the degree to which an antibody or antigen participates in cross reactions. Problem associated with the degree to which an antibody or antigen participates in cross reactions. C62982 Device Ingredient or Reagent Problem 2910 FDA C54451 FDA Device Problem Code Hierarchy C63258 Data Back-Up Problem 2902 IMDRF:A1106 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. 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 Computer Software Problem 1112 FDA C54451 FDA Device Problem Code Hierarchy C91397 Data Problem 3196 IMDRF:A1107 Event in which data (charting, orders, results) is not correctly stored, transferred, updated, or displayed. Event in which data (charting, orders, results) is not correctly stored, transferred, updated, or displayed. C63269 Computer Software Problem 1112 FDA C54451 FDA Device Problem Code Hierarchy C67508 Date/Time-Related Software Problem 2582 IMDRF:A1108 Problem associated with programming of calendar dates and/or time as a factor in the operation of the device. Problem associated with programming of calendar dates and/or time as a factor in the operation of the device. C63269 Computer Software Problem 1112 FDA C54451 FDA Device Problem Code Hierarchy C63256 Decoupling 1145 IMDRF:A1202 Problem associated with the device being unassociated in such a way that fluid, gas, power or signal information may not be transferred from one to another. Problem associated with the device being unassociated in such a way that fluid, gas, power or signal information may not be transferred from one device to another. C62952 Connection Problem 2900 FDA C54451 FDA Device Problem Code Hierarchy C63255 Decrease in Pressure 1490 IMDRF:A141101 Pressure, Decrease In Unintended decrease in pressure, compromising the device's intended function. Unintended decrease in pressure, compromising a medical device's intended function. C62934 Pressure Problem 3012 FDA C54451 FDA Device Problem Code Hierarchy C63254 Decrease in Suction 1146 IMDRF:A141301 Aspiration, Incomplete|Incomplete Aspiration|Suction, Decrease In Problem associated with the removal of fluid or gas from a body cavity due to decreased suction. Problem associated with the removal of fluid or gas from a body cavity due to decreased suction. C62833 Suction Problem 2170 FDA C54451 FDA Device Problem Code Hierarchy C63252 Decreased Pump Speed 1500 IMDRF:A141201 Pump Speed, Decreased Unintended decrease in pump speed and hence, probably, flow rate, compromising the intended function of the device. Unintended decrease in pump speed and subsequent flow rate, compromising the intended function of a medical device. C62860 Pumping Problem 3016 FDA C54451 FDA Device Problem Code Hierarchy C63253 Decreased Sensitivity 2534 IMDRF:A070901 Sensitivity, Decreased|Undersensing Problem with the device being less sensitive to an input than intended or expected. Problem with a medical device being less sensitive to an input than intended or expected. C63238 Device Sensing Problem 2917 FDA C54451 FDA Device Problem Code Hierarchy C63251 Defective Alarm 1014 IMDRF:A160106 Alarm, Defective The device alarm does not operate as expected and/or in agreement with device's specifications. The device alarm does not operate as expected and/or in agreement with device's specifications. C63033 Device Alarm System 1012 FDA C54451 FDA Device Problem Code Hierarchy C63023 Defective Component 2292 IMDRF:A0202 Components, Defective Problem associated with a device component having flaws of dimensional deviations greater than acceptable for the intended use. Problem associated with a device component having flaws of dimensional deviations greater than acceptable for the intended use. C63041 Manufacturing, Packaging or Shipping Problem 2975 FDA C54451 FDA Device Problem Code Hierarchy C63250 Defective Device 2588 IMDRF:A0203 Device, Defective Problem associated with having flaws or dimensional deviations greater than acceptable for the intended use of the device. Problem associated with having flaws or dimensional deviations greater than acceptable for the intended use of the device. C63041 Manufacturing, Packaging or Shipping Problem 2975 FDA C54451 FDA Device Problem Code Hierarchy C63158 Defibrillation Problem 1573 IMDRF:A0713 Shock, Failure To Deliver Problem associated with the inability of the device to provide an appropriate or successful electrical shock. Problem associated with the inability of the device to provide an appropriate or successful electrical shock. C63007 Electrical /Electronic Property Problem 1198 FDA C54451 FDA Device Problem Code Hierarchy C63249 Deflation Problem 1149 IMDRF:A1401 Deflation Difficulties Problem associated with the inability of the device to release its contents. Problem associated with the inability of the device to release its contents. C63075 Infusion or Flow Problem 2964 FDA C54451 FDA Device Problem Code Hierarchy C63287 Deformation Due to Compressive Stress 2889 IMDRF:A040601 Problem associated with an undesired bulge, bend, bow, kink, or wavy condition observed in the device material resulting from compressive stresses. Problem associated with an undesired bulge, bend, bow, kink, or wavy condition observed in the device material resulting from compressive stresses. C63248 Material Deformation 2976 FDA C54451 FDA Device Problem Code Hierarchy C62970 Degraded 1153 IMDRF:A0405 Material Degradation Problem associated with a undesired change in the chemical structure, physical properties, or appearance in the materials that are used in the device construction. Problem associated with a undesired change in the chemical structure, physical properties, or appearance in the materials that are used in the device construction. C62968 Material Integrity Problem 2978 FDA C54451 FDA Device Problem Code Hierarchy C63247 Delayed Alarm 1011 IMDRF:A160104 Alarm, Delayed The device alarm system operates with delay. A device alarm system operates with delay. C63033 Device Alarm System 1012 FDA C54451 FDA Device Problem Code Hierarchy C63280 Delayed Charge Time 2586 IMDRF:A070602 Charge Times, Delayed Problem associated with an unexpected amount of time required to charge the device (e.g. a delay in starting charging or a longer than expected charge time). Problem associated with an unexpected amount of time required to charge the device (e.g. a delay in starting charging or a longer than expected charge time). C63026 Charging Problem 2892 FDA C54451 FDA Device Problem Code Hierarchy C133599 Delayed Program or Algorithm Execution 4034 IMDRF:A110301 Problem associated with delayed execution relating to program or algorithm. Problem associated with a delayed execution relating to program or algorithm. C133593 Program or Algorithm Execution Problem 4033 FDA C54451 FDA Device Problem Code Hierarchy C63014 Delivered as Unsterile Product 1421 IMDRF:A020701 Nonsterility Problem associated with a device being received in such a manner to indicate that its sterility has been compromised (e.g. sterile packaging breached, visible contaminate present). Problem associated with a device being received in such a manner to indicate that its sterility has been compromised (e.g. sterile packaging breached, visible contaminate present). C62925 Shipping Damage or Problem 1570 FDA C54451 FDA Device Problem Code Hierarchy C63245 Dent in Material 2526 IMDRF:A040602 Dent Problem associated with a undesired change in shape, characterized by the presence of a slight hollow (dent) in the device surface. Problem associated with a undesired change in shape, characterized by the presence of a slight hollow (dent) in the device surface. C63248 Material Deformation 2976 FDA C54451 FDA Device Problem Code Hierarchy C63242 Detachment of Device or device Component 2907 IMDRF:A0501 Device Or Device Component Detached Problem associated with the separation of the device from its physical construct, integrity, or chassis. Problem associated with the separation of the device from its physical construct, integrity, or chassis. C62961 Mechanical Problem 1384 FDA C54451 FDA Device Problem Code Hierarchy C63033 Device Alarm System 1012 IMDRF:A1601 Alarm Failure|Alarm, Failure To Problem associated with the alarm system of the device. Problem associated with the alarm system of the device. C62932 Protective Measures Problem 3015 FDA C54451 FDA Device Problem Code Hierarchy C62853 Device Appears to Trigger Rejection 1524 IMDRF:A010102 The device appears to elicit undesired response in the patient to the presence of an implanted or invasive device, without inherent device failure, e.g. fibrous encapsulation, or inflammation of the tissue around the device, or extrusion of the device. The device appears to elicit undesired response in the patient to the presence of an implanted or invasive device, without inherent device failure, e.g. fibrous encapsulation, or inflammation of the tissue around the device, or extrusion of the device. C62919 Patient-Device Incompatibility 2682 FDA C54451 FDA Device Problem Code Hierarchy C63019 Device Contaminated during manufacture or shipping 2969 IMDRF:A1802 Problem 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. Problem 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. C63276 Contamination / decontamination Problem 2895 FDA C54451 FDA Device Problem Code Hierarchy C63016 Device Contamination with Body Fluid 2317 IMDRF:A180103 Blood Contaminated Device Problem associated with the undesired presence of body fluid in/on the device, which are not part of the documented device specifications and requirements. Problem associated with the undesired presence of body fluid in/on the device, which are not part of the documented device specifications and requirements. C63018 Contamination During Use 1120 FDA C54451 FDA Device Problem Code Hierarchy C63133 Device Contamination with Chemical or Other Material 2944 IMDRF:A180104 Foreign Material Problem associated with contamination of the device with chemical substance or other non biologic material. Problem associated with contamination of a device with a chemical substance or other non biologic material. C63018 Contamination During Use 1120 FDA C54451 FDA Device Problem Code Hierarchy C62951 Device Damaged by Another Device 2915 IMDRF:A0502 Problem associated with one device causing harm to another device. Problem associated with one device causing harm to another device. C62961 Mechanical Problem 1384 FDA C54451 FDA Device Problem Code Hierarchy C63015 Device Damaged Prior to Use 2284 IMDRF:A0204 Damage, Internal/External|Damaged Item|Item Damaged Prior To Use Problem associated with packaging or shipping damage prior to the use of the device. Problem associated with packaging or shipping damage prior to the use of a device. C63041 Manufacturing, Packaging or Shipping Problem 2975 FDA C54451 FDA Device Problem Code Hierarchy C79146 Device Difficult to Maintain 3134 IMDRF:A2203 Problem associated with the user's ability to service the device according to the manufacturer specifications relating to the device routine maintenance, i.e., periodic inspection, failure detection, repair, and care of the device to sustain or restore acceptable operating conditions. Problem associated with the user's ability to service a medical device according to the manufacturer specifications relating to a routine device maintenance, i.e., periodic inspection, failure detection, repair, and care of the device to sustain or restore acceptable operating conditions. C76121 Human-Device Interface Problem 2949 FDA C54451 FDA Device Problem Code Hierarchy C64339 Device Difficult to Program or Calibrate 1496 IMDRF:A2202 Program, Difficult To The device is difficult to program, calibrate or set to desired state, even by appropriately trained user/operator. The device that is difficult to program, calibrate or set to desired state, even by appropriately trained user/operator. C76121 Human-Device Interface Problem 2949 FDA C54451 FDA Device Problem Code Hierarchy C63010 Device Difficult to Setup or Prepare 1487 IMDRF:A2201 Prep, Difficult To Problem associated with the use of the device in terms of user experiencing difficulty in preparing device for use, even if the operation is being performed according to labeled instructions for use. Problem associated with the use of the device in terms of user experiencing difficulty in preparing device for use, even if the operation is being performed according to labeled instructions for use. C76121 Human-Device Interface Problem 2949 FDA C54451 FDA Device Problem Code Hierarchy C62950 Device Dislodged or Dislocated 2923 IMDRF:A051201 Problems associated with the device not remaining in an expected location. Problems associated with the device not remaining in an expected location. C62814 Unintended Movement 3026 FDA C54451 FDA Device Problem Code Hierarchy C63205 Device Displays Incorrect Message 2591 IMDRF:A090201 Problem associated with providing incorrect display information. Problem associated with providing incorrect display information. C63088 Display or Visual Feedback Problem 1184 FDA C54451 FDA Device Problem Code Hierarchy C63004 Device Emits Odor 1425 IMDRF:A0301 Problem associated with an unexpected or inappropriate smell released by the device. Problem associated with an unexpected or inappropriate smell released by the device. C62945 Chemical Problem 2893 FDA C54451 FDA Device Problem Code Hierarchy C133516 Device Fell 4014 IMDRF:A051203 Problem associated with the device or a component unexpectedly being dropped or moving down from an intended place. Problem associated with the device or a component unexpectedly being dropped or moving down from an intended place. C62814 Unintended Movement 3026 FDA C54451 FDA Device Problem Code Hierarchy C95879 Device Handling Problem 3265 IMDRF:A2301 Handling of the device not in accordance with specification, prior to use on the patient. Handling of the device not in accordance with specification, prior to use on the patient. C63318 Use of Device Problem 1670 FDA C54451 FDA Device Problem Code Hierarchy C62982 Device Ingredient or Reagent Problem 2910 IMDRF:A0302 Problem associated with any deviations from the documented specifications of the device that relate to any ingredient or reagent characterization. Problem associated with any deviations from the documented specifications of the device that relate to any ingredient or reagent characterization. C62945 Chemical Problem 2893 FDA C54451 FDA Device Problem Code Hierarchy C62976 Device Markings / Labelling Problem 2911 IMDRF:A2101 Problem associated with the written, printed or graphic material accompanying or affixed to the device or any of its packaging. This includes verbal instructions relating to identification, technical description, and usage provided by the device manufacturers. Problems can include but are not limited to this material being unclear, missing, worn out, incorrect or inaccurate. Problem associated with the written, printed or graphic material accompanying or affixed to the device or any of its packaging. This includes verbal instructions relating to identification, technical description, and usage provided by a medical device manufacturers. Problems can include but are not limited to this material being unclear, missing, worn out, incorrect or inaccurate. C63072 Labelling, Instructions for Use or Training Problem 1318 FDA C54451 FDA Device Problem Code Hierarchy C62957 Device Misassembled During Manufacturing / Shipping 2912 IMDRF:A0206 A device found incorrectly assembled when delivered to the user facility. A device found incorrectly assembled when delivered to the user facility. C63041 Manufacturing, Packaging or Shipping Problem 2975 FDA C54451 FDA Device Problem Code Hierarchy C62931 Device Remains Activated 1525 IMDRF:A071801 Problem associated with the device continuing to be in an active state after deactivation was requested. Problem associated with the device continuing to be in an active state after deactivation was requested. C62988 Failure to Shut Off 2939 FDA C54451 FDA Device Problem Code Hierarchy C63099 Device Reprocessing Problem 1091 IMDRF:A1803 Clean, Failure To|Cleaning, Inadequate Problem associated with a failure during any step of reprocessing process (cleaning, disinfection, packaging, labeling, sterilization) of a used or opened from its original packaging, but unused, device. Problem associated with a failure during any step of reprocessing process (cleaning, disinfection, packaging, labeling, sterilization) of a used or opened from its original packaging, but unused, device. C63276 Contamination / decontamination Problem 2895 FDA C54451 FDA Device Problem Code Hierarchy C63238 Device Sensing Problem 2917 IMDRF:A0709 Problem associated with the device feature that are designed to respond to a physical stimulus (temperature, illumination, motion, cardiac rhythms) and that do not transmit a resulting signal for interpretation or measurement. Problem associated with the device feature that are designed to respond to a physical stimulus (temperature, illumination, motion, cardiac rhythms) and that do not transmit a resulting signal for interpretation or measurement. C63007 Electrical /Electronic Property Problem 1198 FDA C54451 FDA Device Problem Code Hierarchy C62840 Device Slipped 1584 IMDRF:A051204 Slippage Problem associated with the device moving or sliding from the intended position. Problem associated with the device moving or sliding from the intended position. C62814 Unintended Movement 3026 FDA C54451 FDA Device Problem Code Hierarchy C62921 Device Tipped Over 2589 IMDRF:A051202 Device Tipover Problem associated with the inability of the device to stay in an upright position. Problem associated with the inability of the device to stay in an upright position. C62814 Unintended Movement 3026 FDA C54451 FDA Device Problem Code Hierarchy C73118 Device Unsafe to Use in Environment 2918 IMDRF:A1907 Problem associated with environmental condition that results in the unsafe use of the device. (e.g. electromagnetic fields, noise, vibration, microbiological contamination etc.) Problem associated with environmental condition that results in the unsafe use of the device. (e.g. electromagnetic fields, noise, vibration, microbiological contamination etc.). C63209 Environmental Compatibility Problem 2929 FDA C54451 FDA Device Problem Code Hierarchy C63236 Device-Device Incompatibility 2919 IMDRF:A1702 Problem 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. The inability of two or more devices to work together. C62983 Compatibility Problem 2960 FDA C54451 FDA Device Problem Code Hierarchy C63035 Difficult or Delayed Activation 2577 IMDRF:A150102 Activation, Difficult /Delayed|Activation, Difficult Or Delayed Problem associated with delayed or difficult activation of the device. Problem associated with delayed or difficult activation of the device. C133631 Activation Problem 4042 FDA C54451 FDA Device Problem Code Hierarchy C63244 Difficult or Delayed Positioning 1157 IMDRF:A150203 Deploy, Difficult To Problem associated with users experiencing difficulty or delay to position the device to a specified location. Problem associated with users experiencing difficulty or delay to position the device to a specified location. C63034 Positioning Problem 3009 FDA C54451 FDA Device Problem Code Hierarchy C133633 Difficult or Delayed Separation 4044 IMDRF:A150302 Problem associated with users experiencing difficulty or delay with detachment or separation of the device. Problem associated with users experiencing difficulty or delay with detachment or separation of the device. C133632 Separation Problem 4043 FDA C54451 FDA Device Problem Code Hierarchy C63235 Difficult to Advance 2920 IMDRF:A150205 Problem associated with difficulty moving the device to an intended location (e.g. difficulty in advancing guide wire). Problem associated with difficulty moving the device to an intended location (e.g. difficulty in advancing guide wire). C63034 Positioning Problem 3009 FDA C54451 FDA Device Problem Code Hierarchy C63317 Difficult to Flush 1251 IMDRF:A1410 Flush, Difficult To The device is difficult to flush, possibly indicating an obstruction within device. The device that is difficult to flush, possibly indicating an obstruction within device. C63075 Infusion or Flow Problem 2964 FDA C54451 FDA Device Problem Code Hierarchy C63234 Difficult to Fold or Unfold 1254 IMDRF:A051103 Fold, Difficult To Problem associated with the use of the device in terms of user experiencing difficulty to close or to spread out/extend length of the device, even if the operation is being performed according to labeled instructions for use. Problem associated with the use of the device in terms of the user experiencing difficulty to close or to spread out/extend length of the device, even if the operation is being performed according to labeled instructions for use. C62923 Structural Problem 2506 FDA C54451 FDA Device Problem Code Hierarchy C63233 Difficult to Insert 1316 IMDRF:A150206 Insertion Difficulties Problem 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. Problem 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 Positioning Problem 3009 FDA C54451 FDA Device Problem Code Hierarchy C63232 Difficult to Interrogate 1331 IMDRF:A071101 Interrogate, Difficult To Problem associated with difficulty of a transponder system to trigger a response. Problem associated with difficulty of a transponder system to trigger a response. C133523 Interrogation Problem 4017 FDA C54451 FDA Device Problem Code Hierarchy C63012 Difficult to Open or Close 2921 IMDRF:A051104 Problem 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. Problem 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 Structural Problem 2506 FDA C54451 FDA Device Problem Code Hierarchy C63231 Difficult to Open or Remove Packaging Material 2922 IMDRF:A020501 Problem associated with difficulty for users to operate the device, specifically as it relates to the opening or removal of the outer wrapping. Problem associated with difficulty for users to operate the device, specifically as it relates to the opening or removal of the outer wrapping. C62939 Packaging Problem 3007 FDA C54451 FDA Device Problem Code Hierarchy C63228 Difficult to Remove 1528 IMDRF:A150207 Removal Difficulties Problem associated with the use of the device in terms of user experiencing difficulty to take out or get rid of the device, even if the user is operating device in accordance with the instructions for use or labeling. Problem associated with the use of the device in terms of user experiencing difficulty to take out or get rid of the device, even if the user is operating device in accordance with the instructions for use or labeling. C63034 Positioning Problem 3009 FDA C54451 FDA Device Problem Code Hierarchy C63223 Disconnection 1171 IMDRF:A1203 Broken Connection|Disconnect Problem associated with the linking of the device having a sufficient open space to prevent gas, liquid or electrical current flow between connectors. Problem associated with the linking of the device having a sufficient open space to prevent gas, liquid or electrical current flow between connectors. C62952 Connection Problem 2900 FDA C54451 FDA Device Problem Code Hierarchy C63221 Display Difficult to Read 1181 IMDRF:A090202 Problem associated with legibility of the display, compromising for instance the reading/interpretation of patient parameters or test results. Legibility problems can be due to color, size of font, display screen contrast or other factors. Problem associated with legibility of the device display, compromising for instance, the reading/interpretation of patient parameters or test results. Legibility problems can be due to color, size of font, display screen contrast or other factors. C63088 Display or Visual Feedback Problem 1184 FDA C54451 FDA Device Problem Code Hierarchy C63088 Display or Visual Feedback Problem 1184 IMDRF:A0902 Display, Incorrect Problem with any deviation from the documented specifications of the device that relate to visual feedback. e.g. the display of information, images on a screen, or output from the device. Problem with any deviation from the documented specifications of the device that relate to visual feedback. e.g. the display of information, images on a screen, or output from the device. C62941 Output Problem 3005 FDA C54451 FDA Device Problem Code Hierarchy C63219 Dull, Blunt 2407 IMDRF:A020101 Problem associated with a device not being as sharp as intended or expected. Problem associated with a device not being as sharp as intended or expected. C62948 Product Quality Problem 1506 FDA C54451 FDA Device Problem Code Hierarchy C133510 Ejection Problem 4009 IMDRF:A0503 Problems associated with the inability of or unexpected removal or separation of the device from its physical location. Problems associated with the inability of or unexpected removal or separation of the device from its physical location. C62961 Mechanical Problem 1384 FDA C54451 FDA Device Problem Code Hierarchy C63007 Electrical /Electronic Property Problem 1198 IMDRF:A07 Device Electrical Issue|Electrical Failure Problem associated with a failure of the electrical circuitry of the device. Problem associated with a failure of the electrical circuitry of the device. C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C63218 Electrical Overstress 2924 IMDRF:A0716 Problem associated with an electrical activity that exceeded the specified threshold limit of the internal integrated circuitry. Problem associated with electrical activity of the device that exceeded the specified threshold limit of the internal integrated circuitry. C63007 Electrical /Electronic Property Problem 1198 FDA C54451 FDA Device Problem Code Hierarchy C63217 Electrical Power Problem 2925 IMDRF:A1910 Problem associated with the quality of the facility-supplied power. Problem associated with the quality of the facility-supplied power to the device. C63209 Environmental Compatibility Problem 2929 FDA C54451 FDA Device Problem Code Hierarchy C63216 Electrical Shorting 2926 IMDRF:A072102 Problem associated with an electric current travelling along an accidental path (unintended path) in a circuit. Problem associated with an electric current travelling along an accidental path (unintended path) in a circuit. C63277 Circuit Failure 1089 FDA C54451 FDA Device Problem Code Hierarchy C63215 Electromagnetic Compatibility Problem 2927 IMDRF:A0720 Problem associated with the ability of a system to function in its electromagnetic environment without introducing intolerable disturbances to anything in its environment. Problem associated with the ability of a system to function in its electromagnetic environment without introducing intolerable disturbances to anything in its environment. C63007 Electrical /Electronic Property Problem 1198 FDA C54451 FDA Device Problem Code Hierarchy C63214 Electromagnetic Interference 1194 IMDRF:A072001 Problem associated with a measure of electromagnetic radiation from equipment. Problem associated with a measure of electromagnetic radiation from equipment. C63215 Electromagnetic Compatibility Problem 2927 FDA C54451 FDA Device Problem Code Hierarchy C63213 Electro-Static Discharge 2149 IMDRF:A0717 Problem associated with the discharge of electricity between two bodies previously electrically charged. Problem associated with the discharge of electricity between two bodies previously electrically charged. C63007 Electrical /Electronic Property Problem 1198 FDA C54451 FDA Device Problem Code Hierarchy C63212 Emergency Power Failure 1205 IMDRF:A191001 Problem associated with the failure of the facility's emergency power backup system(s) including generators and/or interruptible power systems (UPS). Problem associated with the failure of the facility's emergency power backup system(s) including generators and/or interruptible power systems (UPS). C63217 Electrical Power Problem 2925 FDA C54451 FDA Device Problem Code Hierarchy C63002 Energy Output Problem 1431 IMDRF:A0904 Problem with the device's intended output of energy. Problem with the device's intended output of energy. C62941 Output Problem 3005 FDA C54451 FDA Device Problem Code Hierarchy C63000 Energy Spectrum Incorrect 1210 IMDRF:A090401 Problem associated with the energy output from the device not being in the expected part of the spectrum. Problem associated with the energy output from the device not being in the expected part of the spectrum. C63002 Energy Output Problem 1431 FDA C54451 FDA Device Problem Code Hierarchy C63210 Entrapment of Device 1212 IMDRF:A150208 Entrapment Problem associated with the device caught within patient vasculature, tissue, or other device. Issue associated with the device and/or device accessories caught within patient vasculature, tissue, or other device. C63034 Positioning Problem 3009 FDA C54451 FDA Device Problem Code Hierarchy C63209 Environmental Compatibility Problem 2929 IMDRF:A19 Problem 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. Problem 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. C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C72674 Environmental Particulates 2930 IMDRF:A1908 Problem 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. Problem associated with fine solids or liquid particles such as dust, smoke, fume, and/or mist suspended in the immediate atmosphere in which the device is being used. C63209 Environmental Compatibility Problem 2929 FDA C54451 FDA Device Problem Code Hierarchy C63207 Erratic or Intermittent Display 1182 IMDRF:A090203 Display, Erratic A device does not consistently display the same message, result, reading, or image. e.g. the display might flicker, switch between readings or messages, or go completely blank for brief periods of time. A device that does not consistently display the same message, result, reading, or image. e.g. the display might flicker, switch between readings or messages, or go completely blank for brief periods of time. C63088 Display or Visual Feedback Problem 1184 FDA C54451 FDA Device Problem Code Hierarchy C62882 Excess Flow or Over-Infusion 1311 IMDRF:A1402 Overdelivery|Overinfusion Problem associated with a delivery overdose of therapeutic agents, such as drugs or fluids being delivered into a device or a patient. Problem associated with a delivery overdose of therapeutic agents, such as drugs or fluids being delivered into a device or a patient. C63075 Infusion or Flow Problem 2964 FDA C54451 FDA Device Problem Code Hierarchy C63202 Excessive Cooling 2932 IMDRF:A1001 Problem associated with the device producing temperatures that are lower than specified. Problem associated with the device producing temperatures that are lower than specified. C62922 Temperature Problem 3022 FDA C54451 FDA Device Problem Code Hierarchy C133576 Excessive Heating 4030 IMDRF:A1002 Problem associated with the device which has a warming or heating function, and is producing excessive heat. Problem associated with the device which has a warming or heating function, and is producing excessive heat. C62922 Temperature Problem 3022 FDA C54451 FDA Device Problem Code Hierarchy C62999 Expiration Date Error 2528 IMDRF:A210101 Problem associated with errors in identification of expiration date. Problem associated with errors in identification of expiration date. C62976 Device Markings / Labelling Problem 2911 FDA C54451 FDA Device Problem Code Hierarchy C133505 Explosion 4006 IMDRF:A0403 Problem associated with the violent bursting due to the sudden expansion of air, gas or fluid. Problem with the device associated with the violent bursting due to the sudden expansion of air, gas or fluid. C62968 Material Integrity Problem 2978 FDA C54451 FDA Device Problem Code Hierarchy C50554 Expulsion 2933 IMDRF:A010401 Problem with all or part of an implanted or invasive device being completely expelled from its intended location within the body. Problem with all or part of an implanted or invasive medical device being completely expelled from its intended location within the body. C62917 Migration or Expulsion of Device 1395 FDA C54451 FDA Device Problem Code Hierarchy C133635 Fail-Safe Did Not Operate 4046 IMDRF:A160201 Problem associated with the device fail-safe mechanism, which did not function or function in a non effective way, compromising safe use of the device. Problem associated with the device fail-safe mechanism, which did not function or function in a non effective way, compromising safe use of the device. C62997 Fail-Safe Problem 2936 FDA C54451 FDA Device Problem Code Hierarchy C62997 Fail-Safe Problem 2936 IMDRF:A1602 Problem associated with the feature that prevents the unsafe use of the device. Problem associated with the feature that prevents the unsafe use of the device. C62932 Protective Measures Problem 3015 FDA C54451 FDA Device Problem Code Hierarchy C62989 Failure of Device to Self-Test 2937 IMDRF:A1603 Problem associated with the device failing to perform an internal self-diagnostic process to ensure normal operation during or prior to use. Problem associated with the device failing to perform an internal self-diagnostic process to ensure normal operation during or prior to use. C62932 Protective Measures Problem 3015 FDA C54451 FDA Device Problem Code Hierarchy C63198 Failure to Advance 2524 IMDRF:A150204 Advance, Failure To Problem associated with failure to move the device to an intended location. Problem associated with failure to move the device to an intended location. C63034 Positioning Problem 3009 FDA C54451 FDA Device Problem Code Hierarchy C63197 Failure to Align 2522 IMDRF:A050701 Align, Failure To Problem associated with a circuit, equipment, or system whereby its functions fail to be properly synchronized or its relative positions properly oriented. Problem associated with a circuit, equipment, or system whereby its functions fail to be properly synchronized or its relative positions properly oriented. C62960 Mechanics Altered 2984 FDA C54451 FDA Device Problem Code Hierarchy C63196 Failure to Analyze Signal 1539 IMDRF:A070903 Failure To Diagnose Rhythm|Rhythm, Failure To Analyze|Rhythm, Failure To Diagnose Problem with the device not analyzing a signal. Problem with the device not analyzing a signal. C63238 Device Sensing Problem 2917 FDA C54451 FDA Device Problem Code Hierarchy C62995 Failure to Auto Stop 2938 IMDRF:A1604 Problem associated with the inability of device to turn itself off when the device is not in an operable condition. Problem associated with the inability of device to turn itself off when the device is not in an operable condition. C62932 Protective Measures Problem 3015 FDA C54451 FDA Device Problem Code Hierarchy C63195 Failure to Back-Up 1047 IMDRF:A110601 Back-Up, Failure To Problem associated with the inability to backup or to retrieve a backed up version (corrupted file) of device data or system files. Problem associated with the inability to backup or to retrieve a backed up version (corrupted file) of device data or system files. C63258 Data Back-Up Problem 2902 FDA C54451 FDA Device Problem Code Hierarchy C62994 Failure to Calibrate 2440 IMDRF:A0801 Calibrate, Failure To Problem 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. Problem 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 Calibration Problem 2890 FDA C54451 FDA Device Problem Code Hierarchy C62993 Failure to Capture 1081 IMDRF:A070101 Capture, Failure To Problem associated with the failure to achieve effective and consistent depolarization of the heart resulting from the electrical stimulus of the pacemaker. Problem associated with the failure to achieve effective and consistent depolarization of the heart resulting from the electrical stimulus of the pacemaker. C63027 Capturing Problem 2891 FDA C54451 FDA Device Problem Code Hierarchy C63193 Failure to Charge 1085 IMDRF:A070603 Charge, Failure To Problem associated with inability to initiate the appropriate charging process (e.g. of a battery or other charge storage device). Problem associated with inability to initiate the appropriate charging process (e.g. of a battery or other charge storage device). C63026 Charging Problem 2892 FDA C54451 FDA Device Problem Code Hierarchy C133637 Failure to Clean Adequately 4048 IMDRF:A180301 Problem associated with the failure of the device or operator to remove any visible soil, foreign material or organism deposits on the external surfaces, crevices, and joints of the device. Problem associated with the failure of the device or operator to remove any visible soil, foreign material or organism deposits on the external surfaces, crevices, and joints of the device. C63099 Device Reprocessing Problem 1091 FDA C54451 FDA Device Problem Code Hierarchy C63191 Failure to Conduct 1114 IMDRF:A0710 Conduct, Failure To Problem associated with the inability of the device to allow a current of electricity to pass or to conduct electricity continuously along an electrical path. Problem associated with the inability of the device to allow a current of electricity to pass or to conduct electricity continuously along an electrical path. C63007 Electrical /Electronic Property Problem 1198 FDA C54451 FDA Device Problem Code Hierarchy C63190 Failure to Convert Rhythm 1540 IMDRF:A071201 Rhythm, Failure To Convert Failure of the device therapy or set of therapies to terminate the harmful cardiac rhythm that the therapy is meant to terminate. Failure of the device therapy or set of therapies to terminate the harmful cardiac rhythm that the therapy is meant to terminate. C63169 Pacing Problem 1439 FDA C54451 FDA Device Problem Code Hierarchy C63189 Failure to Convert to Back-Up 1048 IMDRF:A110602 Back-Up, Failure To Convert To Problem associated with a failure to transition from a primary system, component, file, procedure to a backup in response to a failure in the primary item. Problem associated with a failure to transition from a primary system, component, file, procedure to a backup in response to a failure in the primary item. C63258 Data Back-Up Problem 2902 FDA C54451 FDA Device Problem Code Hierarchy C63188 Failure to Cut 2587 IMDRF:A050702 Cut, Failure To Inability of the device to make an incision, pierce or open as intended. Inability of the device to make an incision, pierce or open as intended. C62960 Mechanics Altered 2984 FDA C54451 FDA Device Problem Code Hierarchy C63187 Failure to Cycle 1142 IMDRF:A050703 Cycle, Failure To Problem associated with the device failing to complete a series of processes or events. Problem associated with the device failing to complete a series of processes or events. C62960 Mechanics Altered 2984 FDA C54451 FDA Device Problem Code Hierarchy C63186 Failure to Deliver 2338 IMDRF:A140801 Deliver, Failure To Failure (=complete nonperformance) with regard to the intended function of delivery. Failure (=complete nonperformance) with regard to the intended function of delivery. C62902 No Flow 2991 FDA C54451 FDA Device Problem Code Hierarchy C63184 Failure to Deliver Energy 1211 IMDRF:A090402 Energy, Failure To Deliver Problem associated with the failure of the device to deliver any energy. Problem associated with the failure of the device to deliver any energy. C63002 Energy Output Problem 1431 FDA C54451 FDA Device Problem Code Hierarchy C63185 Failure to Deliver Shock 1133 IMDRF:A071301 Countershock, Failure To Deliver|Failure To Countershock Problem associated with the failure of the device to deliver electrical energy intended to change an electrical rhythm. Problem associated with the failure of the device to deliver electrical energy intended to change an electrical rhythm. C63158 Defibrillation Problem 1573 FDA C54451 FDA Device Problem Code Hierarchy C63181 Failure to Discharge 1169 IMDRF:A0707 Discharge, Failure To Problem associated with the failure of a battery or other charge storage device to appropriately discharge as intended. Does not apply to defibrillation. Problem associated with the failure of a battery or other charge storage device to appropriately discharge as intended. Does not apply to defibrillation. C63007 Electrical /Electronic Property Problem 1198 FDA C54451 FDA Device Problem Code Hierarchy C63180 Failure to Disconnect 2541 IMDRF:A1204 Disconnect, Failure To Problem associated with the linking of the device 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. Problem associated with the linking of the device 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 Connection Problem 2900 FDA C54451 FDA Device Problem Code Hierarchy C63179 Failure to Disinfect 1175 IMDRF:A180302 Disinfect, Failure To|Disinfection, Inadequate/Improper Failure to properly disinfect the device when reprocessing it. Failure to properly disinfect the device during reprocessing. C63099 Device Reprocessing Problem 1091 FDA C54451 FDA Device Problem Code Hierarchy C133511 Failure to Eject 4010 IMDRF:A050301 Problem associated with the inability to remove or discharge the device from the location of use. Problem associated with the inability to remove or discharge device from the location of use. C133510 Ejection Problem 4009 FDA C54451 FDA Device Problem Code Hierarchy C63177 Failure to Fire 2610 IMDRF:A050501 Fire, Failure To Problem associated with failure of the device to discharge its load (e.g. surgical stapler failed to partially or completely deploy its staples). Problem associated with failure of the device to discharge its load (e.g. surgical stapler failed to partially or completely deploy its staples). C133512 Firing Problem 4011 FDA C54451 FDA Device Problem Code Hierarchy C63175 Failure to Fold 1255 IMDRF:A040603 Fold, Failure To Problem associated with an undesired material change in physical property, characterized by failure to fold. Problem associated with an undesired material change in the physical property of the device which is characterized by failure to fold. C63248 Material Deformation 2976 FDA C54451 FDA Device Problem Code Hierarchy C64328 Failure to Form Staple 2579 IMDRF:A050704 Problem associated with the device failing to connect tissue with a stapling device due to the staples not forming correctly. Problem associated with the device failing to connect tissue with a stapling device due to the staples not forming correctly. C62960 Mechanics Altered 2984 FDA C54451 FDA Device Problem Code Hierarchy C63174 Failure to Infuse 2340 IMDRF:A140802 Infuse, Failure To Failure (=complete nonperformance) with regard to the intended function of infusion. Failure (=complete nonperformance) with regard to the intended function of infusion. C62902 No Flow 2991 FDA C54451 FDA Device Problem Code Hierarchy C63173 Failure to Interrogate 1332 IMDRF:A071102 Interrogate, Failure To Problem associated with the device failure to appropriately respond to signals from a system designed to interrogate its status. Problem associated with the device failure to appropriately respond to signals from a system designed to interrogate its status. C133523 Interrogation Problem 4017 FDA C54451 FDA Device Problem Code Hierarchy C63172 Failure to Obtain Sample 2533 IMDRF:A090802 Samples, Failure To Obtain The device does not collect or transfer the sample. The device does not collect or transfer the sample as intended. C62848 Incorrect, Inadequate or Imprecise Result or Readings 1535 FDA C54451 FDA Device Problem Code Hierarchy C63171 Failure to Osseointegrate 1863 IMDRF:A010201 Osseointegrate, Failure To Problem 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. Problem associated with the failure to see direct anchorage of an implant by the formation of bony tissue around the implant without the growth of fibrous tissue at the bone-implant interface. C62886 Osseointegration Problem 3003 FDA C54451 FDA Device Problem Code Hierarchy C62992 Failure to Power Up 1476 IMDRF:A070803 Power-Up, Failure To Problem associated with the inability of the device to turn on related to energy delivered to the device. Problem associated with the inability of the device to turn on related to energy delivered to a medical device. C63025 Power Problem 3010 FDA C54451 FDA Device Problem Code Hierarchy C63167 Failure to Prime 1492 IMDRF:A141401 Prime, Failure To Problem associated with the device failing to begin the priming process (i.e. the process of preparation of device for the delivery of fluids). Problem associated with the device failing to begin the priming process (i.e. the process of preparation of device for the delivery of fluids). C133629 Priming Problem 4040 FDA C54451 FDA Device Problem Code Hierarchy C63165 Failure to Pump 1502 IMDRF:A141203 Pump, Failure To Problem associated with the device which fails to start pumping. Problem associated with the device which fails to start pumping. C62860 Pumping Problem 3016 FDA C54451 FDA Device Problem Code Hierarchy C63164 Failure to Read Input Signal 1581 IMDRF:A1301 Input Signal, Failure To Read Problem associated with a failure of the device to read a signal for interpretation or measurement. Problem associated with a failure of the device to read a signal for interpretation or measurement. C63271 Communication or Transmission Problem 2896 FDA C54451 FDA Device Problem Code Hierarchy C63241 Failure to Recalibrate 1517 IMDRF:A0802 Recalibrate, Failure To Problem associated with the failure of the device which is unable to regain a standard level of accuracy when performing a calibration procedure or process designed to assure the accuracy and proper performance of the device. Problem associated with the failure of the device which is unable to regain a standard level of accuracy when performing a calibration procedure or process designed to assure the accuracy and proper performance of the device. C63028 Calibration Problem 2890 FDA C54451 FDA Device Problem Code Hierarchy C62991 Failure to Reset 1532 IMDRF:A160501 Reset, Failure To Problem associated with the device failing to set a variable, register, or other storage location back to a prescribed state. Problem associated with the device failing to set a variable, register, or other storage location back to a prescribed state. C62852 Reset Problem 3019 FDA C54451 FDA Device Problem Code Hierarchy C62990 Failure to Run on Battery 1466 IMDRF:A070503 Portable Mode, Failure To Run On Problem associated with the device failing to operate when not connected to a fixed power source. Problem associated with the device failing to operate when not connected to a fixed power source. C63030 Battery Problem 2885 FDA C54451 FDA Device Problem Code Hierarchy C63161 Failure to Select Signal 1582 IMDRF:A070904 Signal, Failure To Select Problem associated with the failure of the device to select the appropriate input signal. Problem associated with the failure of the device to select the appropriate input signal. C63238 Device Sensing Problem 2917 FDA C54451 FDA Device Problem Code Hierarchy C63160 Failure to Sense 1559 IMDRF:A070908 Sensing, None Problem associated with the failure of the device designed to respond to a physical stimulus (as temperature, illumination, motion) to transmit a resulting signal for interpretation or measurement. Problem associated with the failure of the device designed to respond to a physical stimulus (as temperature, illumination, motion) to transmit a resulting signal for interpretation or measurement. C63238 Device Sensing Problem 2917 FDA C54451 FDA Device Problem Code Hierarchy C62988 Failure to Shut Off 2939 IMDRF:A0718 Problem associated with the device not powering off when a shut down was requested. Problem associated with the device not powering off when a shut down was requested. C63007 Electrical /Electronic Property Problem 1198 FDA C54451 FDA Device Problem Code Hierarchy C63155 Failure to Transmit Record 1521 IMDRF:A1302 Record, Failure To Transmit Problem associated with a failure of the device to transmit a record for interpretation or measurement. Problem associated with a failure of the device to transmit a record for interpretation or measurement. C63271 Communication or Transmission Problem 2896 FDA C54451 FDA Device Problem Code Hierarchy C62949 Failure to Unfold or Unwrap 1669 IMDRF:A040604 Difficult To Unfold Or Unwrap Problem associated with the comprising materials' deformation in that device fails to open its wrapping or open/extend in a certain manner i.e. balloon or lens. Problem associated with the comprising materials' deformation in that device fails to open its wrapping or open/extend in a certain manner i.e. balloon or lens. C63248 Material Deformation 2976 FDA C54451 FDA Device Problem Code Hierarchy C62987 Failure to Zero 1683 IMDRF:A160502 Zero, Failure To Problem associated with the device failing to set a variable, register, or other storage location back to zero. Problem associated with the device failing to set a variable, register, or other storage location back to zero. C62852 Reset Problem 3019 FDA C54451 FDA Device Problem Code Hierarchy C63152 False Alarm 1013 IMDRF:A160105 Alarm, False Problem associated with the device providing incorrect alarm warning or alert to user. Problem associated with the device providing incorrect alarm warning or alert to user. C63033 Device Alarm System 1012 FDA C54451 FDA Device Problem Code Hierarchy C63149 False Negative Result 1225 IMDRF:A090803 False-Negative Test Result Problem associated with the device incorrectly reporting that something has not been detected and may mislead the operator into not taking certain actions when action should be taken. Problem associated with the device incorrectly reporting that something has not been detected and may mislead the operator into not taking certain actions when action should be taken. C62848 Incorrect, Inadequate or Imprecise Result or Readings 1535 FDA C54451 FDA Device Problem Code Hierarchy C63147 False Positive Result 1227 IMDRF:A090804 False-Positive Test Result Problem associated with the device incorrectly reporting that something has been detected and may mislead the operator to take certain actions. Problem associated with the device incorrectly reporting that something has been detected and may mislead the operator to take certain actions. C62848 Incorrect, Inadequate or Imprecise Result or Readings 1535 FDA C54451 FDA Device Problem Code Hierarchy C63144 Filling Problem 1233 IMDRF:A1403 Problem 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. Problem 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 Infusion or Flow Problem 2964 FDA C54451 FDA Device Problem Code Hierarchy C62986 Filtration Problem 2941 IMDRF:A1404 Problem associated with the process of passing a substance through a porous medium, e.g., a blood clot filter for the removal of suspended matter. Problem associated with the process of passing a substance through a porous medium, e.g., a blood clot filter for the removal of suspended matter. C63075 Infusion or Flow Problem 2964 FDA C54451 FDA Device Problem Code Hierarchy C63143 Fire 1245 IMDRF:A1007 Problem associated with the combustion of the device with a steady flame. Problem associated with the combustion of the device with a steady flame. C62922 Temperature Problem 3022 FDA C54451 FDA Device Problem Code Hierarchy C133512 Firing Problem 4011 IMDRF:A0505 Problem associated with the device not discharging as intended. Problem associated with the device not discharging as intended. C62961 Mechanical Problem 1384 FDA C54451 FDA Device Problem Code Hierarchy C63142 Fitting Problem 2183 IMDRF:A1208 Fitting Problems Problem associated with the connection of the device 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. Problem associated with the connection of the device whereby channels, switching systems, and other functional units set up to provide means for a transfer of liquid, gas, electricity, or information do not match or fit. C62952 Connection Problem 2900 FDA C54451 FDA Device Problem Code Hierarchy C63141 Flaked 1246 IMDRF:A040505 Flaked Material|Flaking Problem associated with the detachment of small pieces of the coating film of a material. Problem associated with the detachment of small pieces of the coating film of a material. C62970 Degraded 1153 FDA C54451 FDA Device Problem Code Hierarchy C63140 Flare or Flash 2942 IMDRF:A1008 Problem associated with device-related burn with an unsteady flame. Problem associated with the device-related burn with an unsteady flame. C62922 Temperature Problem 3022 FDA C54451 FDA Device Problem Code Hierarchy C63137 Fluid Leak 1250 IMDRF:A050401 Fluid Leak(s) Escape (Release, Discharge) of fluid through an unintended location - often accompanied by a loss of pressure and/or output. Escape (release, discharge) of fluid through an unintended location that is often accompanied by a loss of pressure and/or output. C63058 Leak / Splash 1354 FDA C54451 FDA Device Problem Code Hierarchy C63176 Flushing problem 1252 IMDRF:A180303 Flush, Failure To Flushing process was not executed properly. Flushing process was not executed properly. C63099 Device Reprocessing Problem 1091 FDA C54451 FDA Device Problem Code Hierarchy C63135 Fogging 1253 IMDRF:A190601 Problem associated with the visibility of water vapor in the immediate atmosphere in which the device is being used. Problem associated with the visibility of water vapor in the immediate atmosphere in which the device is being used. C62807 Ventilation Problem in Device Environment 3027 FDA C54451 FDA Device Problem Code Hierarchy C63132 Fracture 1260 IMDRF:A040101 Fracture(s) Of Device/Material Problem associated with a partial or full-thickness crack in the device materials. Problem associated with a partial or full-thickness crack in the device materials. C62973 Break 1069 FDA C54451 FDA Device Problem Code Hierarchy C63130 Free or Unrestricted Flow 2945 IMDRF:A140502 Problem associated with uncontrolled flow of infusion of air, gas or fluids. Problem associated with uncontrolled flow of infusion of air, gas or fluids. C63110 Improper Flow or Infusion 2954 FDA C54451 FDA Device Problem Code Hierarchy C63129 Fumes or Vapors 2529 IMDRF:A1903 Fumes/Vapors Problem associated with the visibility, odor, or toxicity of an ambient vapor or gas. Problem associated with the visibility, odor, or toxicity of an ambient vapor or gas. C63209 Environmental Compatibility Problem 2929 FDA C54451 FDA Device Problem Code Hierarchy C63128 Fungus in Device Environment 2316 IMDRF:A1904 Fungus Problem associated with the visibility of molds, mildews, yeasts, and/or mushrooms in the immediate environment in which the device is being used. Problem associated with the visibility of molds, mildews, yeasts, and/or mushrooms in the immediate environment in which the device is being used. C63209 Environmental Compatibility Problem 2929 FDA C54451 FDA Device Problem Code Hierarchy C63127 Gas Leak 2946 IMDRF:A050402 Problem associated with the unintended escape of a gas from the container in which it is housed. Problem associated with the unintended escape of a gas from the container in which it is housed. C63058 Leak / Splash 1354 FDA C54451 FDA Device Problem Code Hierarchy C63109 Gas output problem 1266 IMDRF:A0906 Gas Output, Improper Problem associated with gas output. Problem associated with gas output. C62941 Output Problem 3005 FDA C54451 FDA Device Problem Code Hierarchy C63316 Gel Leak 1267 IMDRF:A050403 Gel Leakage Escape (Release, Discharge) of gel through an unintended location - as in leakage of ultrasound gel. Escape or release of gel from containment structures - as in gel filled implant leak. Escape (release, discharge) of gel through an unintended location - as in leakage of ultrasound gel. Escape or release of gel from containment structures - as in gel filled implant leak. C63058 Leak / Splash 1354 FDA C54451 FDA Device Problem Code Hierarchy C63126 Gradient Increase 1270 IMDRF:A140503 Problem associated with the increased rate of change in temperature, pressure, or other variables as a function of distance, time, etc. Problem associated with the increased rate of change in temperature, pressure, or other variables as a function of distance, time, etc. C63110 Improper Flow or Infusion 2954 FDA C54451 FDA Device Problem Code Hierarchy C63125 Grounding Malfunction 1271 IMDRF:A0715 Problem associated with the inability to connect conductors of an electronic system for the purpose of controlling or impeding ground currents and voltages. Problem associated with the inability to connect conductors of an electronic system for the purpose of controlling or impeding ground currents and voltages. C63007 Electrical /Electronic Property Problem 1198 FDA C54451 FDA Device Problem Code Hierarchy C95875 High Capture Threshold 3266 IMDRF:A070102 Capture Threshold, High Problem with the amount of output energy needed to cause cardiac depolarization being higher than expected/desired. Problem with the amount of output energy needed to cause cardiac depolarization being higher than expected/desired. C63027 Capturing Problem 2891 FDA C54451 FDA Device Problem Code Hierarchy C63124 High impedance 1291 IMDRF:A072201 Impedance, High Problem associated with higher than intended electrical impedance levels between device and patient connections. Problem associated with higher than intended electrical impedance levels between device and patient connections. C63114 Impedance Problem 2950 FDA C54451 FDA Device Problem Code Hierarchy C62981 High pH 2426 IMDRF:A030206 pH, High pH higher than expected and / or anticipated. pH higher than expected and/or anticipated. C62982 Device Ingredient or Reagent Problem 2910 FDA C54451 FDA Device Problem Code Hierarchy C63123 High Readings 2459 IMDRF:A090807 Readings, High Reading provided by the device is too high or higher than expected. Reading provided by the device is too high or higher than expected. C62848 Incorrect, Inadequate or Imprecise Result or Readings 1535 FDA C54451 FDA Device Problem Code Hierarchy C63121 High Sensing Threshold 2574 IMDRF:A070905 Sensing Threshold, High Problem associated with the amount of input required by the device to detect a signal being higher than expected/desired. Problem associated with the amount of input required by the device to detect a signal being higher than expected/desired. C63238 Device Sensing Problem 2917 FDA C54451 FDA Device Problem Code Hierarchy C63122 High Test Results 2457 IMDRF:A090809 Test Results, High Test results provided by the device are too high or higher than expected. Test results provided by the device are too high or higher than expected. C62848 Incorrect, Inadequate or Imprecise Result or Readings 1535 FDA C54451 FDA Device Problem Code Hierarchy C76121 Human-Device Interface Problem 2949 IMDRF:A22 Problem associated with an act or omission of an act that has a different result than that intended by the manufacturer or expected by the operator. Problem associated with an act or omission of an act that has a different result than that intended by the manufacturer or expected by the operator. C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C133642 Illegible Information 4050 IMDRF:A210102 Problem associated with information unable to be read or deciphered. Problem associated with information unable to be read or deciphered. C62976 Device Markings / Labelling Problem 2911 FDA C54451 FDA Device Problem Code Hierarchy C63117 Image Display Error / Artifact 1304 IMDRF:A090204 Problem with image display leading to corrupted images or readouts/measurement indications. Problem with image display leading to corrupted images or readouts/measurement indications. C63088 Display or Visual Feedback Problem 1184 FDA C54451 FDA Device Problem Code Hierarchy C62887 Image Orientation Incorrect 1305 IMDRF:A090205 Problem associated with an incorrect image orientation on the device display. Problem associated with an incorrect image orientation on the device display. C63088 Display or Visual Feedback Problem 1184 FDA C54451 FDA Device Problem Code Hierarchy C63114 Impedance Problem 2950 IMDRF:A0722 Problem associated with electrical impedance levels between device and patient connections. Problem associated with electrical impedance levels between device and patient connections. C63007 Electrical /Electronic Property Problem 1198 FDA C54451 FDA Device Problem Code Hierarchy C63113 Imprecision 1307 IMDRF:A0803 Problem associated with the device providing imprecise measurements when compared to a reference standard. Problem associated with the device providing imprecise measurements when compared to a reference standard. C63028 Calibration Problem 2890 FDA C54451 FDA Device Problem Code Hierarchy C63111 Improper Chemical Reaction 2952 IMDRF:A0303 Problem associated with an unexpected or incomplete chemical reaction or effect. Problem associated with an unexpected or incomplete chemical reaction or effect. C62945 Chemical Problem 2893 FDA C54451 FDA Device Problem Code Hierarchy C63110 Improper Flow or Infusion 2954 IMDRF:A1405 Problem associated with the regulation and delivery of therapeutic agents (e.g. air, gas, drugs or fluids into a device or a patient under positive pressure). Problem associated with the regulation and delivery of therapeutic agents (e.g. air, gas, drugs or fluids into a device or a patient under positive pressure). C63075 Infusion or Flow Problem 2964 FDA C54451 FDA Device Problem Code Hierarchy C62862 Improper or Incorrect Procedure or Method 2017 IMDRF:A2303 Improper Or Incorrect Method|Method Improper/Incorrect|Procedure, Improper/Incorrect Problem associated with the use of the device in terms of nonconforming to that device's intended use, specifications, procedure and process or service instructions and information provided by the device manufacturers. Problem associated with the use of the device in terms of nonconforming to that device's intended use, specifications, procedure and process or service instructions and information provided by the device manufacturers. C63318 Use of Device Problem 1670 FDA C54451 FDA Device Problem Code Hierarchy C63106 Inability to Auto-Fill 1044 IMDRF:A140301 Autofill, Unable To Complete failure to fill as part of an automated process. For insufficient filling use "Short Fill". For excessive filling use "Overfill". For inconsistent filling use "Volume Accuracy Problem". Complete failure to fill as part of an automated process. For insufficient filling use Short Fill. For excessive filling use Overfill. For inconsistent filling use Volume Accuracy Problem. C63144 Filling Problem 1233 FDA C54451 FDA Device Problem Code Hierarchy C63105 Inability to Irrigate 1337 IMDRF:A140803 Irrigate, Inability To Failure (=complete nonperformance) with regard to the intended function of irrigation. Failure (=complete nonperformance) with regard to the intended function of irrigation. C62902 No Flow 2991 FDA C54451 FDA Device Problem Code Hierarchy C63104 Inaccurate Delivery 2339 IMDRF:A140504 Delivery, Inaccurate Delivery at endpoint not as intended; either too low or too high. Delivery at endpoint not as intended; either too low or too high. C63110 Improper Flow or Infusion 2954 FDA C54451 FDA Device Problem Code Hierarchy C63102 Inaccurate Flow rate 1249 IMDRF:A140505 Flowrate, Inaccurate Problem associated with fluctuations in the flow volume delivered per time, even if end volume is correct, and delivered in the correct total time. Problem associated with fluctuations in the flow volume delivered per time, even if end volume is correct, and delivered in the correct total time. C63110 Improper Flow or Infusion 2954 FDA C54451 FDA Device Problem Code Hierarchy C133643 Inaccurate Information 4051 IMDRF:A210103 Problem associated with imprecise, inexact information. Problem associated with imprecise, inexact information. C62976 Device Markings / Labelling Problem 2911 FDA C54451 FDA Device Problem Code Hierarchy C63101 Inaccurate Synchronization 1609 IMDRF:A071202 Synchronization, Inaccurate Problem associated with an error due to imperfect timing of two operations, e.g. signal transmission time. Problem associated with an error due to imperfect timing of two operations, e.g. signal transmission time. C63169 Pacing Problem 1439 FDA C54451 FDA Device Problem Code Hierarchy C62947 Inadequacy of Device Shape and/or Size 1583 IMDRF:A010103 Size, Incorrect The physical size and/or shape of the device was inadequate with regard to the patient's anatomy. The physical size and/or shape of the device was inadequate with regard to the patient's anatomy. C62919 Patient-Device Incompatibility 2682 FDA C54451 FDA Device Problem Code Hierarchy C62985 Inadequate Filtration Process 2308 IMDRF:A140401 Filtration Process, Inadequate Problem associated with the filter failing to remove items or substances which should have been removed. Problem associated with the filter failing to remove items or substances which should have been removed. C62986 Filtration Problem 2941 FDA C54451 FDA Device Problem Code Hierarchy C63087 Inadequate Instructions for Healthcare Professional 1319 IMDRF:A2103 Instructions, Incorrect Problem associated with inaccuracies in any written, printed, or graphic matter that is affixed to the device or its packaging with any matter that accompanies the device including verbal instructions related to identification, technical description and use of device provided by the device manufacturers that is intended for healthcare professionals. Problem associated with inaccuracies in any written, printed, or graphic matter that is affixed to the device or its packaging with any matter that accompanies the device including verbal instructions related to identification, technical description and use of the device provided by the device manufacturers that is intended for healthcare professionals. C63072 Labelling, Instructions for Use or Training Problem 1318 FDA C54451 FDA Device Problem Code Hierarchy C63267 Inadequate Instructions for Non-Healthcare Professional 2956 IMDRF:A2104 Problem associated with users being unclear and not able to follow any written, printed, or graphic matter that is affixed to device or its packaging with any matter that accompanies the device including verbal instructions related to identification, technical description and use of the device provided by the device manufactures that vary from the standard of medical care in a given environment. Problem associated with users being unclear and not able to follow any written, printed, or graphic matter that is affixed to device or its packaging with any matter that accompanies a medical device including verbal instructions related to identification, technical description and use of the device provided by a medical device manufacturer that vary from the standard of medical care in a given environment. C63072 Labelling, Instructions for Use or Training Problem 1318 FDA C54451 FDA Device Problem Code Hierarchy C73117 Inadequate or Insufficient Training 1643 IMDRF:A2105 Problem associated with facility not providing satisfactory initial and/or periodic user training covering operation of the device. Problem associated with facility not providing satisfactory initial and/or periodic user training covering operation of a medical device. C63072 Labelling, Instructions for Use or Training Problem 1318 FDA C54451 FDA Device Problem Code Hierarchy C62827 Inadequate Ultra Filtration 1656 IMDRF:A140402 Problem associated with the transfer of fluid between the blood and dialysate through the dialysis membrane due to a pressure gradient (trans-membrane pressure) existing between the blood and dialysate compartments. Problem associated with the transfer of fluid between the blood and dialysate through the dialysis membrane due to a pressure gradient (trans-membrane pressure) existing between the blood and dialysate compartments. C62986 Filtration Problem 2941 FDA C54451 FDA Device Problem Code Hierarchy C63100 Inadequate User Interface 2958 IMDRF:A2204 Problem associated with the means by which the operator and the equipment communicate or interact. Problem associated with the means by which the operator and the equipment communicate or interact. C76121 Human-Device Interface Problem 2949 FDA C54451 FDA Device Problem Code Hierarchy C63094 Inappropriate Audible Prompt / Feedback 2280 IMDRF:A090101 Prompts, Inappropriate Problem with audible messages which do not guide a device user to the correct action. Problem with audible messages which do not guide a device user to the correct action. C133545 Audible Prompt / Feedback 4020 FDA C54451 FDA Device Problem Code Hierarchy C63031 Inappropriate or Unexpected Reset 2959 IMDRF:A160503 Problem associated with the device setting a variable, register, or other storage location to an inappropriate or unexpected state. Problem associated with the device setting a variable, register, or other storage location to an inappropriate or unexpected state. C62852 Reset Problem 3019 FDA C54451 FDA Device Problem Code Hierarchy C63093 Inappropriate Shock 1574 IMDRF:A071302 Shock, Inappropriate Problem associated with the inappropriate delivery of an electrical energy. Problem associated with the inappropriate delivery of an electrical energy. C63158 Defibrillation Problem 1573 FDA C54451 FDA Device Problem Code Hierarchy C133551 Inappropriate Tactile Prompt / Feedback 4023 IMDRF:A090301 Problem with tactile feedback which does not guide a device user to the correct action. Problem with tactile feedback which does not guide a device user to the correct action. C133547 Tactile Prompts / Feedback 4022 FDA C54451 FDA Device Problem Code Hierarchy C63157 Inappropriate waveform 2536 IMDRF:A071203 Spike, Failure To Failure of the device to generate a correctly-shaped pacing output, e.g., a waveform that is too wide. Failure of the device to generate a correctly-shaped pacing output, e.g., a waveform that is too wide. C63169 Pacing Problem 1439 FDA C54451 FDA Device Problem Code Hierarchy C63092 Inaudible or Unclear Audible Prompt / Feedback 2283 IMDRF:A090102 Prompts, Inaudible Voice Problem associated with audible prompts which cannot be heard clearly. Problem associated with audible prompts which cannot be heard clearly. C133545 Audible Prompt / Feedback 4020 FDA C54451 FDA Device Problem Code Hierarchy C63090 Incomplete Coaptation 2507 IMDRF:A051105 Problem associated with the heart valve leaflet not closing properly. Problem associated with the heart valve leaflet not closing properly. C62923 Structural Problem 2506 FDA C54451 FDA Device Problem Code Hierarchy C133626 Incomplete or Inadequate Connection 4037 IMDRF:A1207 Problem associated with a partial linking of the device whereby device may appear to be connected however only a partial, intermittent or no transfer of liquid, gas, electricity, or information can be accomplished. Problem associated with a partial linking of the device whereby the device may appear to be connected however only a partial, intermittent or no transfer of liquid, gas, electricity, or information can be accomplished. C62952 Connection Problem 2900 FDA C54451 FDA Device Problem Code Hierarchy C133630 Incomplete or Inadequate Priming 4041 IMDRF:A141402 Problem associated with not adequately preparing the device. Problem associated with not adequately preparing the device. C133629 Priming Problem 4040 FDA C54451 FDA Device Problem Code Hierarchy C62940 Incomplete or Missing Packaging 2312 IMDRF:A020502 Packaging, Incomplete/Missing Problem associated with the nonconformance to the device specifications due to incomplete or missing packaging that may compromise the device operation as intended. Problem associated with the nonconformance to the device specifications due to incomplete or missing packaging that may compromise the device operation as intended. C62939 Packaging Problem 3007 FDA C54451 FDA Device Problem Code Hierarchy C63086 Incorrect Interpretation of signal 1543 IMDRF:A070912 Rhythm, Incorrect Interpretation Of Problem with the device inappropriately analyzing a signal. Problem with the device inappropriately analyzing a signal. C63238 Device Sensing Problem 2917 FDA C54451 FDA Device Problem Code Hierarchy C63085 Incorrect Measurement 1383 IMDRF:A090805 Measurements, Inaccurate Measurement obtained from or provided by the device is obviously incorrect. Measurement obtained from or provided by the device is obviously incorrect. C62848 Incorrect, Inadequate or Imprecise Result or Readings 1535 FDA C54451 FDA Device Problem Code Hierarchy C62848 Incorrect, Inadequate or Imprecise Result or Readings 1535 IMDRF:A0908 Results Incorrect Problem associated with a nonconforming end result, data, or test results provided by the device to its performance specifications. Problem associated with a nonconforming end result, data, or test results provided by the device to its performance specifications. C62941 Output Problem 3005 FDA C54451 FDA Device Problem Code Hierarchy C63080 Increase in Pressure 1491 IMDRF:A141102 Pressure, Increase In Unintended increase in pressure, compromising the device's intended function. Unintended increase in pressure, compromising the device's intended function. C62934 Pressure Problem 3012 FDA C54451 FDA Device Problem Code Hierarchy C63079 Increase in Suction 1604 IMDRF:A141302 Aspiration, Excessive|Excessive Aspiration|Suction, Increase In Problem associated with the removal of excess fluid or gas from a body cavity due to increased suction. Problem associated with the removal of excess fluid or gas from a body cavity due to increased suction. C62833 Suction Problem 2170 FDA C54451 FDA Device Problem Code Hierarchy C63077 Increased Pump Speed 1501 IMDRF:A141202 Pump Speed, Increased Unintended increase in pump speed and hence, probably, flow rate, compromising the intended function of the device. Unintended increase in pump speed and hence, probably, flow rate, compromising the intended function of the device. C62860 Pumping Problem 3016 FDA C54451 FDA Device Problem Code Hierarchy C63078 Increased Sensitivity 2535 IMDRF:A070902 Oversensing|Sensitivity, Increased Problem with the device being more sensitive to an input than intended or expected. Problem with a medical device being more sensitive to an input than intended or expected. C63238 Device Sensing Problem 2917 FDA C54451 FDA Device Problem Code Hierarchy C63076 Inflation Problem 1310 IMDRF:A1406 Inflation Difficulties Problem associated with the inability of the device to expand or enlarge with the intended inflation agent (e.g. saline or air). Problem associated with the inability of the device to expand or enlarge with the intended inflation agent (e.g. saline or air). C63075 Infusion or Flow Problem 2964 FDA C54451 FDA Device Problem Code Hierarchy C63075 Infusion or Flow Problem 2964 IMDRF:A14 Problem associated with the device failing to deliver liquids or gases as intended (e.g. delivering drugs at incorrect rate, Problems with drawing fluid from a system.) Problem associated with the device failing to deliver liquids or gases as intended (e.g. delivering drugs at incorrect rate, problems with drawing fluid from a system.) C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C63074 Installation-Related Problem 2965 IMDRF:A20 Installation Error Problem associated with unsatisfactory installation, configuration, and/or setup of a specific device. Problem associated with unsatisfactory installation, configuration, and/or setup of a specific device. C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C63071 Insufficient Cooling 1130 IMDRF:A1003 Cooling, Inadequate Problem associated with the device insufficiently cooled in device active (working) or/and non-active (nonworking) state. Problem associated with the device insufficiently cooled in device active (working) or/and non-active (nonworking) state. C62922 Temperature Problem 3022 FDA C54451 FDA Device Problem Code Hierarchy C62823 Insufficient Flow or Under Infusion 2182 IMDRF:A1407 Underdelivery|Underinfusion Problem associated with an insufficient dose of therapeutic agents, e.g., drugs or fluids being delivered into a patient under positive pressure. Problem associated with an insufficient dose of therapeutic agents, e.g., drugs or fluids being delivered into a patient under positive pressure. C63075 Infusion or Flow Problem 2964 FDA C54451 FDA Device Problem Code Hierarchy C63070 Insufficient Heating 1287 IMDRF:A1004 Heating, Inadequate Problem associated with the device or its components producing temperatures that are not as high as what is specified. Problem associated with the device or its components producing temperatures that are not as high as what is specified. C62922 Temperature Problem 3022 FDA C54451 FDA Device Problem Code Hierarchy C53269 Insufficient Information 3190 IMDRF:A26 No Answer Provided An adverse event appears to have occurred but there is not yet enough information available to classify the device problem. Information regarding the subject is unknown or inaccessible at this time. C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C63069 Intermittent Capture 1080 IMDRF:A070103 Capture, Intermittent Problem associated with the ineffective and inconsistent depolarization of the heart. Problem associated with the ineffective and inconsistent depolarization of the heart. C63027 Capturing Problem 2891 FDA C54451 FDA Device Problem Code Hierarchy C133627 Intermittent Communication Failure 4038 IMDRF:A1303 Inconsistent or lack of intended communication of data among internal components or with other external devices. Inconsistent or lack of intended communication of data among internal components or with other external devices. C63271 Communication or Transmission Problem 2896 FDA C54451 FDA Device Problem Code Hierarchy C63068 Intermittent Continuity 1121 IMDRF:A072103 Continuity, Intermittent Problem associated with intermittent faults in electrical/electronic interconnections. Problem associated with intermittent faults in electrical/electronic interconnections. C63277 Circuit Failure 1089 FDA C54451 FDA Device Problem Code Hierarchy C133561 Intermittent Energy Output 4025 IMDRF:A090403 Problem associated with the energy output from the device being inconsistent over time. Problem associated with the energy output from the device being inconsistent over time. C63002 Energy Output Problem 1431 FDA C54451 FDA Device Problem Code Hierarchy C63067 Intermittent Infusion 2341 IMDRF:A140506 Infusion, Intermittent Problem associated with the infusion not being steady, characterized by intermittent stoppages to the flow. Problem associated with the infusion not being steady, characterized by intermittent stoppages to the flow. C63110 Improper Flow or Infusion 2954 FDA C54451 FDA Device Problem Code Hierarchy C133520 Intermittent loss of power 4016 IMDRF:A070802 Problem associated with an intermittent disruption to the power to run the device. Problem associated with an intermittent disruption to the power to run the device. C63025 Power Problem 3010 FDA C54451 FDA Device Problem Code Hierarchy C133603 Intermittent Program or Algorithm Execution 4035 IMDRF:A110302 Problem associated with intermittent execution relating to program or algorithm. Problem associated with intermittent execution relating to program or algorithm. C133593 Program or Algorithm Execution Problem 4033 FDA C54451 FDA Device Problem Code Hierarchy C63064 Intermittent Shock 2287 IMDRF:A071303 Shock, Intermittent Problem 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. Problem 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 Defibrillation Problem 1573 FDA C54451 FDA Device Problem Code Hierarchy C133523 Interrogation Problem 4017 IMDRF:A0711 Problems associated with the device's ability to respond to signals from a system designed to interrogate its status. Problems associated with the device's ability to respond to signals from a system designed to interrogate its status. C63007 Electrical /Electronic Property Problem 1198 FDA C54451 FDA Device Problem Code Hierarchy C63072 Labelling, Instructions for Use or Training Problem 1318 IMDRF:A21 Instructions, Inadequate Problem associated with device markings / labelling, instructions for use, training and maintenance documentation or guidelines. Problem associated with device markings/labeling, instructions for use, training and maintenance documentation or guidelines. C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C72671 Lack of Maintenance Documentation or Guidelines 2971 IMDRF:A2102 Problem associated with user facility not receiving adequate service documentation, guidelines, or recommendations to perform preventative and corrective maintenance and performance assurance checks. Problem associated with user facility not receiving adequate service documentation, guidelines, or recommendations to perform preventative and corrective maintenance and performance assurance checks. C63072 Labelling, Instructions for Use or Training Problem 1318 FDA C54451 FDA Device Problem Code Hierarchy C63058 Leak / Splash 1354 IMDRF:A0504 Leak(s) Problem associated with the escape of a liquid or gas from the vessel or container in which it is housed. Problem associated with the escape of a liquid or gas from the vessel or container in which it is housed. C62961 Mechanical Problem 1384 FDA C54451 FDA Device Problem Code Hierarchy C63055 Loose or Intermittent Connection 1371 IMDRF:A1205 Connection(s), Loose Problem associated with the connection of the device being loose or intermittent. Problem associated with the connection of the device being loose or intermittent. C62952 Connection Problem 2900 FDA C54451 FDA Device Problem Code Hierarchy C133497 Loosening of Implant Not Related to Bone-Ingrowth 4002 IMDRF:A0103 Problem associated with the loss of direct anchorage of an implanted device over time or due to an injury. Problem associated with the loss of direct anchorage of an implanted device over time or due to an injury. C133496 Patient Device Interaction Problem 4001 FDA C54451 FDA Device Problem Code Hierarchy C63257 Loss of Data 2903 IMDRF:A110701 Data Corruption|Data Loss Event in which data is unintentionally permanently or temporarily lost, deleted, corrupted, or overwritten. Event in which data is unintentionally permanently or temporarily lost, deleted, corrupted, or overwritten. C91397 Data Problem 3196 FDA C54451 FDA Device Problem Code Hierarchy C63194 Loss of or Failure to Bond 1068 IMDRF:A040102 Bond, Failure To Problem associated with lack or loss of adherence between materials intended to be joined together by an adhesive. Problem associated with lack or loss of adherence between materials intended to be joined together by an adhesive. C62973 Break 1069 FDA C54451 FDA Device Problem Code Hierarchy C63053 Loss of Osseointegration 2408 IMDRF:A010202 Osseointegration, Loss Of Problem associated with weakened integration of the device at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device. i.e. 'Loosening/Lysis.' Problem associated with weakened integration of the device at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device. i.e. 'Loosening/Lysis.' C62886 Osseointegration Problem 3003 FDA C54451 FDA Device Problem Code Hierarchy C63052 Loss of Power 1475 IMDRF:A191002 Power, Loss Of Problem associated with the failure of primary power supplied by the facility. Problem associated with the failure of primary power supplied by the facility. C63217 Electrical Power Problem 2925 FDA C54451 FDA Device Problem Code Hierarchy C63050 Loss of Threshold 1633 IMDRF:A070907 Threshold, Loss Of Problem associated with the loss of the minimum amount of energy, voltage, or current needed to consistently stimulate the heart muscle. Problem associated with the loss of the minimum amount of energy, voltage, or current needed to consistently stimulate the heart muscle. C63238 Device Sensing Problem 2917 FDA C54451 FDA Device Problem Code Hierarchy C63049 Low Audible Alarm 1016 IMDRF:A160103 Alarm, Low Audible The audible device alarm cannot be heard clearly. The audible device alarm cannot be heard clearly. C63033 Device Alarm System 1012 FDA C54451 FDA Device Problem Code Hierarchy C63047 Low impedance 2285 IMDRF:A072202 Impedance, Low Problem associated with lower than intended electrical impedance levels between device and patient connections. Problem associated with lower than intended electrical impedance levels between device and patient connections. C63114 Impedance Problem 2950 FDA C54451 FDA Device Problem Code Hierarchy C133500 Low pH 4005 IMDRF:A030207 pH lower than expected and / or anticipated. pH lower than expected and / or anticipated. C62982 Device Ingredient or Reagent Problem 2910 FDA C54451 FDA Device Problem Code Hierarchy C63046 Low Readings 2460 IMDRF:A090808 Readings, Low Reading provided by the device is too low or lower than expected. Reading provided by the device is too low or lower than expected. C62848 Incorrect, Inadequate or Imprecise Result or Readings 1535 FDA C54451 FDA Device Problem Code Hierarchy C63044 Low Sensing Threshold 2575 IMDRF:A070906 Sensing Threshold, Low Problem associated with the amount of an input required by the device to detect a signal being lower than expected/desired. Problem associated with the amount of an input required by the device to detect a signal being lower than expected/desired. C63238 Device Sensing Problem 2917 FDA C54451 FDA Device Problem Code Hierarchy C63045 Low Test Results 2458 IMDRF:A090810 Test Results, Low Test results provided by the device are too low or lower than expected. Test results provided by the device are too low or lower than expected. C62848 Incorrect, Inadequate or Imprecise Result or Readings 1535 FDA C54451 FDA Device Problem Code Hierarchy C63043 Malposition of device 2616 IMDRF:A150202 Malposition Problem associated with the device being positioned in a location other than intended or specified. Problem associated with the device being positioned in a location other than intended or specified. C63034 Positioning Problem 3009 FDA C54451 FDA Device Problem Code Hierarchy C63041 Manufacturing, Packaging or Shipping Problem 2975 IMDRF:A02 Problem associated with any deviations from the documented specifications of the device that relate to nonconformity during manufacture to the design of an item or to specified manufacturing, packaging or shipping processes (out of box problem). Problem associated with any deviations from the documented specifications of the device that relate to nonconformity during manufacture to the design of an item or to specified manufacturing, packaging or shipping processes (out of box problem). C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C63248 Material Deformation 2976 IMDRF:A0406 Problem associated with an undesired material change in shape or property caused by external forces. Problem associated with an undesired material change in shape or property caused by external forces. C62968 Material Integrity Problem 2978 FDA C54451 FDA Device Problem Code Hierarchy C63224 Material Discolored 1170 IMDRF:A0407 Discolored Problem associated with an undesired streak, pattern and/or a noticeable change in color from the rest of the materials used in the device construction. Problem associated with an undesired streak, pattern and/or a noticeable change in color from the rest of the materials used in the device construction. C62968 Material Integrity Problem 2978 FDA C54451 FDA Device Problem Code Hierarchy C63222 Material Disintegration 1177 IMDRF:A0408 Disintegrate Problem associated with material breaking into small particles. Problem associated with material breaking into small pieces. C62968 Material Integrity Problem 2978 FDA C54451 FDA Device Problem Code Hierarchy C63208 Material Erosion 1214 IMDRF:A040503 Erosion Problem associated with a progressive loss of a material from a solid surface. Problem associated with a progressive loss of a material from a solid surface. C62970 Degraded 1153 FDA C54451 FDA Device Problem Code Hierarchy C62969 Material Fragmentation 1261 IMDRF:A040103 Fragmentation Problem associated with small pieces of the device breaking off unexpectedly. Problem associated with small pieces of the device breaking off unexpectedly. C62973 Break 1069 FDA C54451 FDA Device Problem Code Hierarchy C63131 Material Frayed 1262 IMDRF:A040605 Frayed Problem associated with the comprising materials having damaged edges. Problem associated with the comprising materials having damaged edges. C63248 Material Deformation 2976 FDA C54451 FDA Device Problem Code Hierarchy C62968 Material Integrity Problem 2978 IMDRF:A04 Problem associated with any deviations from the documented specifications of the device that relate to the limited durability of all material used to construct device. Problem associated with any deviations from the documented specifications of the device that relate to the limited durability of all material used to construct the device. C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C63063 Material Invagination 1336 IMDRF:A040606 Invagination Problem associated with an undesired material change in shape, characterized by the infolding of one part within another part of a structure. Problem associated with an undesired material change in shape, characterized by the infolding of one part within another part of a structure. C63248 Material Deformation 2976 FDA C54451 FDA Device Problem Code Hierarchy C62895 Material Opacification 1426 IMDRF:A0409 Opacification|Opaque Problem associated with an undesirable opaqueness or cloudiness. Problem associated with an undesirable opaqueness or cloudiness. C62968 Material Integrity Problem 2978 FDA C54451 FDA Device Problem Code Hierarchy C62967 Material Perforation 2205 IMDRF:A0410 Perforation Material constituting device is perforated possibly compromising the device's intended purpose. Material constituting device is perforated possibly compromising the device's intended purpose. C62968 Material Integrity Problem 2978 FDA C54451 FDA Device Problem Code Hierarchy C72891 Material Protrusion / Extrusion 2979 IMDRF:A0411 Problem associated with undesired physical appearance of device material, specifically when material extends beyond or above device surface. Problem associated with undesired physical appearance of device material, specifically when material extends beyond or above device surface. C62968 Material Integrity Problem 2978 FDA C54451 FDA Device Problem Code Hierarchy C62966 Material Puncture / Hole 1504 IMDRF:A041001 Puncture Device material(s) punctured leading to undesired holes/openings. Device material(s) punctured leading to undesired holes/openings. C62967 Material Perforation 2205 FDA C54451 FDA Device Problem Code Hierarchy C62965 Material Rupture 1546 IMDRF:A0412 Rupture Problem associated with perforations that lead to bursting of the device. Problem associated with perforations that lead to bursting of the device. C62968 Material Integrity Problem 2978 FDA C54451 FDA Device Problem Code Hierarchy C62964 Material Separation 1562 IMDRF:A0413 Separates|Separation Problem associated with an undesired disassociation or breaking apart of the device. Problem associated with an undesired disassociation or breaking apart of the device. C62968 Material Integrity Problem 2978 FDA C54451 FDA Device Problem Code Hierarchy C133509 Material Split, Cut or Torn 4008 IMDRF:A0414 Problem associated with materials consisting the device are split, cut or torn due to external forces (e.g. wrenching or laceration) or internal forces (e.g. exceeding the tensile stress limits belonging to the materials used in the device construction). Problem associated with materials comprising the device are split, cut or torn due to external forces (e.g. wrenching or laceration) or internal forces (e.g. exceeding the tensile stress limits belonging to the materials used in the device construction). C62968 Material Integrity Problem 2978 FDA C54451 FDA Device Problem Code Hierarchy C62847 Material Too Rigid or Stiff 1544 IMDRF:A040607 Rigid|Rigid Or Stiff Problem associated with an undesired material change in physical property, characterized by rigidity (it resists deformation in response to an applied force). Problem associated with an undesired material change in physical property, characterized by rigidity (it resists deformation in response to an applied force). C63248 Material Deformation 2976 FDA C54451 FDA Device Problem Code Hierarchy C133507 Material Too Soft / Flexible 4007 IMDRF:A040608 Problem associated with any device material that results in the material's inability to maintain the desired shape or support function. Problem associated with the device material that results in the material's inability to maintain the desired shape or support function. C63248 Material Deformation 2976 FDA C54451 FDA Device Problem Code Hierarchy C62962 Material Twisted / Bent 2981 IMDRF:A040609 Problem associated with deformations that lead to twisting or bending of the device. Problem associated with deformations that lead to twisting or bending of the device. C63248 Material Deformation 2976 FDA C54451 FDA Device Problem Code Hierarchy C63040 Measurement System Incompatibility 2982 IMDRF:A1703 Problem 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. Problem 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 Compatibility Problem 2960 FDA C54451 FDA Device Problem Code Hierarchy C63039 Mechanical Jam 2983 IMDRF:A0506 The motion of the device is prevented or restricted. The motion of the device is prevented or restricted. C62961 Mechanical Problem 1384 FDA C54451 FDA Device Problem Code Hierarchy C62961 Mechanical Problem 1384 IMDRF:A05 Mechanical Failure Problems associated with mechanical actions or defects, including moving parts or subassemblies, etc. Problems associated with mechanical actions or defects of the device, which includes any moving parts or subassemblies, etc. C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C62960 Mechanics Altered 2984 IMDRF:A0507 Problem associated with a device mechanical functioning of machinery, moving parts or tools of device being changed or modified. Problem associated with a device mechanical functioning of machinery, moving parts or tools of device being changed or modified. C62961 Mechanical Problem 1384 FDA C54451 FDA Device Problem Code Hierarchy C72887 Medical Gas Supply Problem 2985 IMDRF:A1909 Problem associated with the facility-supplied medical gases such as medical air, oxygen, nitrous oxide, and nitrogen. Problem associated with the facility-supplied medical gases such as medical air, oxygen, nitrous oxide, and nitrogen. C63209 Environmental Compatibility Problem 2929 FDA C54451 FDA Device Problem Code Hierarchy C62908 Melted 1385 IMDRF:A040610 Material Molten|Melts Problem associated with a solid device being transformed into a molten or liquid state. Problem associated with a solid device being transformed into a molten or liquid state. C63248 Material Deformation 2976 FDA C54451 FDA Device Problem Code Hierarchy C63297 Microbial Contamination of Device 2303 IMDRF:A180105 Bacterial Contamination|Contamination, Bacterial Problem associated with undesired microbial contamination of the device. Problem associated with undesired microbial contamination of the device. C63018 Contamination During Use 1120 FDA C54451 FDA Device Problem Code Hierarchy C133722 Migration 4003 IMDRF:A010402 Problem with all or part of an implanted or invasive device moving from its intended location within the body. Problem with all or part of an implanted or invasive device moving from its intended location within the body. C62917 Migration or Expulsion of Device 1395 FDA C54451 FDA Device Problem Code Hierarchy C62917 Migration or Expulsion of Device 1395 IMDRF:A0104 Problem with an implanted or invasive device moving within the body, or being completely expelled from the body. Problem with an implanted or invasive device moving within the body, or being completely expelled from the body. C133496 Patient Device Interaction Problem 4001 FDA C54451 FDA Device Problem Code Hierarchy C62958 Misassembled 1398 IMDRF:A2305 Misassembly Problem associated with incorrect assembly of the device or constituents after being put into use. Problem associated with incorrect assembly of the device or constituents after being put into use. C63318 Use of Device Problem 1670 FDA C54451 FDA Device Problem Code Hierarchy C133721 Misassembled During Installation 4049 IMDRF:A2001 Problem associated with the use of the device characterized by incorrect assembly of device components, parts or constituents. Problem associated with the use of the device characterized by incorrect assembly of device components, parts or constituents. C63074 Installation-Related Problem 2965 FDA C54451 FDA Device Problem Code Hierarchy C79147 Misassembly by Users 3133 IMDRF:A230501 Problem associated with incorrect assembly of the device or constituents by the users. Problem associated with incorrect assembly of a medical device or constituents by the users. C62958 Misassembled 1398 FDA C54451 FDA Device Problem Code Hierarchy C133646 Misassembly during Maintenance / Repair 4054 IMDRF:A230502 Problem associated with incorrect assembly of the device or constituents during maintenance or repair. Problem associated with incorrect assembly of the device or constituents during maintenance or repair. C62958 Misassembled 1398 FDA C54451 FDA Device Problem Code Hierarchy C62915 Misconnection 1399 IMDRF:A1206 Improper Connection Problem associated with the connection of the device being improper or not in accordance with device specification, requirements or intended uses. Problem associated with the connection of the device being improper or not in accordance with device specification, requirements or intended uses. C62952 Connection Problem 2900 FDA C54451 FDA Device Problem Code Hierarchy C62914 Misfire 2532 IMDRF:A050502 Issue associated with failure of device to discharge its load (e.g., surgical stapler failed to partially or completely deploy its staples). Issue associated with failure of device to discharge its load (e.g., surgical stapler failed to partially or completely deploy its staples). C133512 Firing Problem 4011 FDA C54451 FDA Device Problem Code Hierarchy C62913 Misfocusing 1401 IMDRF:A0601 The problem relates to the poor focusing of the object or the focus is on the wrong object or in the wrong area. The problem relates to the poor focusing of the object or the focus is on the wrong object or in the wrong area. C62953 Optical Problem 3001 FDA C54451 FDA Device Problem Code Hierarchy C133645 Missing Information 4053 IMDRF:A210105 Absence of information e.g. labeling, instruction for use. Absence of information e.g. labeling, instruction for use. C62976 Device Markings / Labelling Problem 2911 FDA C54451 FDA Device Problem Code Hierarchy C95878 Missing Test Results 3267 IMDRF:A090812 Test Results, Missing Problem associated with the results of a test or measurement not appearing. Problem associated with the results of a test or measurement not appearing. C62848 Incorrect, Inadequate or Imprecise Result or Readings 1535 FDA C54451 FDA Device Problem Code Hierarchy C62910 Moisture Damage 1405 IMDRF:A190501 Problem associated with damage inflicted upon the device from water vapor or water in the immediate environment in which the device is being used. Problem associated with damage inflicted upon the device from water vapor or water in the immediate environment in which the device is being used. C62909 Moisture or Humidity Problem 2986 FDA C54451 FDA Device Problem Code Hierarchy C62909 Moisture or Humidity Problem 2986 IMDRF:A1905 Problem associated with an unsatisfactory humidity level in the storage or use environment which affects the device performance. Problem associated with an unsatisfactory humidity level in the storage or use environment which affects the device performance. C63209 Environmental Compatibility Problem 2929 FDA C54451 FDA Device Problem Code Hierarchy C62906 Naturally Worn 2988 IMDRF:A040507 Problem 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. Problem 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 Degraded 1153 FDA C54451 FDA Device Problem Code Hierarchy C48660 No Apparent Adverse Event 3189 IMDRF:A25 A report has been received but the description provided does not appear to relate to an adverse event. This code allows a report to be recorded for administration purposes, even if it doesn't meet the requirements for adverse event reporting.|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. C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C63310 No Audible Alarm 1019 IMDRF:A160102 Alarm, Not Audible The device fails to emit an audible alarm. The device fails to emit an audible alarm. C63033 Device Alarm System 1012 FDA C54451 FDA Device Problem Code Hierarchy C62899 No Audible Prompt / Feedback 2282 IMDRF:A090103 Prompts, No Voice Problem associated with the device ceasing to provide audible prompts. Problem associated with the device ceasing to provide audible prompts. C133545 Audible Prompt / Feedback 4020 FDA C54451 FDA Device Problem Code Hierarchy C62900 No Device Output 1435 IMDRF:A0907 Output, None Problem associated with no measurement outcome, value or data obtained from the device. Problem associated with no measurement outcome, value or data obtained from the device. C62941 Output Problem 3005 FDA C54451 FDA Device Problem Code Hierarchy C62904 No Display / Image 1183 IMDRF:A090206 Display, Failure To Problem associated with the absence of display or image. Problem associated with the absence of display or image. C63088 Display or Visual Feedback Problem 1184 FDA C54451 FDA Device Problem Code Hierarchy C62903 No Fail-Safe Mechanism 2990 IMDRF:A160202 The device does not have a fail-safe mechanism, although such mechanism would be required for its appropriate and/or safe functioning. The device that does not have a fail-safe mechanism, although such mechanism would be required for its appropriate and/or safe functioning. C62997 Fail-Safe Problem 2936 FDA C54451 FDA Device Problem Code Hierarchy C62902 No Flow 2991 IMDRF:A1408 Problem arising from the device failing to deliver the specified liquid or gas. Problem arising from the device failing to deliver the specified liquid or gas. C63075 Infusion or Flow Problem 2964 FDA C54451 FDA Device Problem Code Hierarchy C95877 No Pacing 3268 IMDRF:A071204 Problem associated with the device ceasing to deliver paces. Problem associated with the device ceasing to deliver paces. C63169 Pacing Problem 1439 FDA C54451 FDA Device Problem Code Hierarchy C64243 No Pressure 2994 IMDRF:A141103 Unintended complete loss of pressure, compromising the device's intended function. Unintended complete loss of pressure, compromising the device's intended function. C62934 Pressure Problem 3012 FDA C54451 FDA Device Problem Code Hierarchy C133559 No Tactile Prompts / Feedback 4024 IMDRF:A090302 Problem associated with the device ceasing to provide tactile feedback. Problem associated with the device ceasing to provide tactile feedback. C133547 Tactile Prompts / Feedback 4022 FDA C54451 FDA Device Problem Code Hierarchy C133546 No Visual Prompts / Feedback 4021 IMDRF:A090207 Problem associated with the device ceasing to provide visual feedback. Problem associated with the device ceasing to provide visual feedback. C63088 Display or Visual Feedback Problem 1184 FDA C54451 FDA Device Problem Code Hierarchy C99179 Noise, Audible 3273 IMDRF:A0508 Acoustic Noise|Audible Noise|Noise, Acoustic Problem associated with any unintended sound which emanates from the device (for example, squeaking from two parts rubbing together or buzzing sounds from electrical components). An unintended or unpleasant sound that emanates from a device. C62961 Mechanical Problem 1384 FDA C54451 FDA Device Problem Code Hierarchy C133574 Non Reproducible Results 4029 IMDRF:A090806 Device results cannot be reliably reproduced. Device results that cannot be reliably reproduced. C62848 Incorrect, Inadequate or Imprecise Result or Readings 1535 FDA C54451 FDA Device Problem Code Hierarchy C62898 Nonstandard device 1420 IMDRF:A020102 Problem associated with the device that does not meet the specifications or requirements for which it was manufactured (e.g. materials, parts, manufacturing process). Problem associated with the device that does not meet the specifications or requirements for which it was manufactured (e.g. materials, parts, manufacturing process). C62948 Product Quality Problem 1506 FDA C54451 FDA Device Problem Code Hierarchy C62897 Obstruction of Flow 2423 IMDRF:A1409 Obstruction Problem related to an obstruction or blockage within the device component (e.g. tube, opening, pipe) that results in restriction of flow. Problem related to an obstruction or blockage within the device component (e.g. tube, opening, pipe) that results in restriction of flow. C63075 Infusion or Flow Problem 2964 FDA C54451 FDA Device Problem Code Hierarchy C63082 Off-Label Use 1494 IMDRF:A2304 Product, Incorrect Problem associated with the device which has been used for an unapproved indication or for an unapproved intended use. Problem associated with the device which has been used for an unapproved indication or for an unapproved intended use. C63318 Use of Device Problem 1670 FDA C54451 FDA Device Problem Code Hierarchy C62894 Operating System Becomes Nonfunctional 2996 IMDRF:A110401 Problem associated with malfunction of the computer operating system as opposed to an application software problem. Problem associated with malfunction of the computer operating system as opposed to an application software problem. C63270 Computer Operating System Problem 2898 FDA C54451 FDA Device Problem Code Hierarchy C62893 Operating System Version or Upgrade Problem 2997 IMDRF:A110402 Problem associated with replacing an older operating system to an up-to-date operating system. Problem associated with replacing an older operating system to an up-to-date operating system. C63270 Computer Operating System Problem 2898 FDA C54451 FDA Device Problem Code Hierarchy C62891 Optical Decentration 1360 IMDRF:A0602 Lens, Decentration Of Problem associated with being off-center of optical lenses. Problem associated with being off-center of optical lenses. C62953 Optical Problem 3001 FDA C54451 FDA Device Problem Code Hierarchy C62890 Optical Discoloration 2999 IMDRF:A0603 Problem associated with an undesired change of color. Problem associated with an undesired change of color. C62953 Optical Problem 3001 FDA C54451 FDA Device Problem Code Hierarchy C62889 Optical Distortion 3000 IMDRF:A0604 Problem associated with an optical defect in an image-forming system whereby the image is not the shape of an ideal image of the object. Problem associated with an optical defect in an image-forming system whereby the image is not the shape of an ideal image of the object. C62953 Optical Problem 3001 FDA C54451 FDA Device Problem Code Hierarchy C62888 Optical Obstruction 3002 IMDRF:A0605 Problem associated with the blocking of optical devices, e.g. visual pathways. Problem associated with the blocking of optical devices, e.g. visual pathways. C62953 Optical Problem 3001 FDA C54451 FDA Device Problem Code Hierarchy C62953 Optical Problem 3001 IMDRF:A06 Problem associated with transmission of visible light affecting the quality of the image transmitted or otherwise affecting the intended application of the visible light path. Problem associated with transmission of visible light affecting the quality of the image transmitted or otherwise affecting the intended application of the visible light path. C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C62886 Osseointegration Problem 3003 IMDRF:A0102 Problem associated with interconnection between the bone tissue and the implanted device. Problem associated with interconnection between the bone tissue and the implanted device. C133496 Patient Device Interaction Problem 4001 FDA C54451 FDA Device Problem Code Hierarchy C62943 Output above Specifications 1432 IMDRF:A090404 Device output is exceeding the documented specifications of the device. Device output is exceeding the documented specifications of the device. C63002 Energy Output Problem 1431 FDA C54451 FDA Device Problem Code Hierarchy C62942 Output below Specifications 3004 IMDRF:A090405 Device output is below the documented specifications of the device. Device output is below the documented specifications of the device. C63002 Energy Output Problem 1431 FDA C54451 FDA Device Problem Code Hierarchy C62941 Output Problem 3005 IMDRF:A09 Problem associated with any deviation from the documented specifications of the device that relate to the end result, data, or test results provided by the device. Problem associated with any deviation from the documented specifications of the device that relate to the end result, data, or test results provided by the device. C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C72890 Overcorrection 3006 IMDRF:A0804 Problem associated with an adjustment that surpasses a set of criteria. Problem associated with an adjustment that surpasses a set of criteria. C63028 Calibration Problem 2890 FDA C54451 FDA Device Problem Code Hierarchy C62884 Overfill 2404 IMDRF:A140302 Excessive filling of a device. For complete failure to fill use "inability to auto-fill". For insufficient filling use "Short Fill". For inconsistent filling - use "Volume Accuracy Problem". Excessive filling of a device. For complete failure to fill use inability to auto-fill. For insufficient filling use Short Fill. For inconsistent filling - use Volume Accuracy Problem. C63144 Filling Problem 1233 FDA C54451 FDA Device Problem Code Hierarchy C62883 Overheating of Device 1437 IMDRF:A1005 Overheat Problem associated with the device producing high temperatures, such that its operation is compromised or harm is caused (e.g. overheating that produces melting of components or automatic shutdown). Problem associated with the device producing high temperatures, such that its operation is compromised or harm is caused (e.g. overheating that produces melting of components or automatic shutdown). C62922 Temperature Problem 3022 FDA C54451 FDA Device Problem Code Hierarchy C62881 Over-Sensing 1438 IMDRF:A070909 Problem related to failure of the device to properly filter cardiac signals resulting in inappropriate device response. Problem related to failure of the device to properly filter cardiac signals resulting in inappropriate device response. C63238 Device Sensing Problem 2917 FDA C54451 FDA Device Problem Code Hierarchy C62880 Pacemaker Found in Back-Up Mode 1440 IMDRF:A071205 A device with a pacing function found in back-up Mode. This may be an appropriate fail-safe action (e.g. end of battery life), or be caused by device-malfunction or due to operator error. A device with a pacing function found in back-up mode. This may be an appropriate fail-safe action (e.g. end of battery life), or be caused by device-malfunction or due to operator error. C63169 Pacing Problem 1439 FDA C54451 FDA Device Problem Code Hierarchy C63298 Pacing Asynchronously 1441 IMDRF:A071206 Problem 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. Problem 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 Pacing Problem 1439 FDA C54451 FDA Device Problem Code Hierarchy C63097 Pacing Inadequately 1442 IMDRF:A071207 Pacing voltage or pulse width is less than desired. Pacing voltage or pulse width is less than desired. C63169 Pacing Problem 1439 FDA C54451 FDA Device Problem Code Hierarchy C63066 Pacing Intermittently 1443 IMDRF:A071208 Problem 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. Problem 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 Pacing Problem 1439 FDA C54451 FDA Device Problem Code Hierarchy C63169 Pacing Problem 1439 IMDRF:A0712 Pace, Failure To Problem associated with the inability of the device to generate a therapeutic simulated heart beat via electrical impulses. Problem associated with the inability of the device to generate a therapeutic simulated heart beat via electrical impulses. C63007 Electrical /Electronic Property Problem 1198 FDA C54451 FDA Device Problem Code Hierarchy C62939 Packaging Problem 3007 IMDRF:A0205 Problem associated with the materials used to construct the cover or outer wrapping of the device. Problem associated with the materials used to construct the cover or outer wrapping of the device. C63041 Manufacturing, Packaging or Shipping Problem 2975 FDA C54451 FDA Device Problem Code Hierarchy C63289 Partial Blockage 1065 IMDRF:A140902 Blockage Problem related to an obstruction or blockage within the device component (e.g. tube, opening, pipe) that results in a reduction of the flow rate. Problem related to an obstruction or blockage within the device component (e.g. tube, opening, pipe) that results in a reduction of the flow rate. C62897 Obstruction of Flow 2423 FDA C54451 FDA Device Problem Code Hierarchy C62879 Particulates 1451 IMDRF:A030205 Substances that consist of separate particles that are introduced by the device during use. Substances that consist of separate particles that are introduced by the device during use. C62982 Device Ingredient or Reagent Problem 2910 FDA C54451 FDA Device Problem Code Hierarchy C91398 Patient Data Problem 3197 IMDRF:A110702 Event in which data is accessed by the healthcare provider and either the wrong patient or the wrong data is retrieved despite correct inquiry procedures. Event in which data is accessed by the healthcare provider and either the wrong patient or the wrong data is retrieved despite correct inquiry procedures. C91397 Data Problem 3196 FDA C54451 FDA Device Problem Code Hierarchy C133496 Patient Device Interaction Problem 4001 IMDRF:A01 Problem related to the interaction between the patient and the device. Problem related to the interaction between the patient and a medical device. C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C62919 Patient-Device Incompatibility 2682 IMDRF:A0101 Problem associated with the interaction between the patient's physiology or anatomy and the device that affects the patient and/or the device. Problem associated with the interaction between the patient's physiology or anatomy and the device that affects the patient and/or the device. C133496 Patient Device Interaction Problem 4001 FDA C54451 FDA Device Problem Code Hierarchy C62878 Peeled / Delaminated 1454 IMDRF:A040506 Peeling or delamination of composite materials, including coatings, that occurs when layers are separated as a result of stress or impact and resulting in loss of mechanical toughness. Peeling or delamination of composite materials, including coatings, that occurs when layers are separated as a result of stress or impact and resulting in loss of mechanical toughness. C62970 Degraded 1153 FDA C54451 FDA Device Problem Code Hierarchy C62876 Perivalvular Leak 1457 IMDRF:A050405 Leak(s), Perivalvular|Paravalvular Leak(s) Problem associated with the escape of blood around a heart valve, particularly around its leaflets. Problem associated with the escape of blood around a heart valve, particularly around its leaflets. C63058 Leak / Splash 1354 FDA C54451 FDA Device Problem Code Hierarchy C133513 Physical Resistance / Sticking 4012 IMDRF:A0509 Problem associated with the lack of movement in the device due parts sticking or seizing. Problem associated with the lack of movement in the device due parts sticking or seizing. C62961 Mechanical Problem 1384 FDA C54451 FDA Device Problem Code Hierarchy C62874 Pitted 1460 IMDRF:A040504 Pitting Problem associated with the corrosion of a material's surface, confined to a point or small area that takes the form of cavities. Problem associated with the corrosion of a material's surface, confined to a point or small area that takes the form of cavities. C62970 Degraded 1153 FDA C54451 FDA Device Problem Code Hierarchy C62872 Pocket Stimulation 1463 IMDRF:A071209 Problem associated with a pocket of skin in which the pulse generator is housed. Problem associated with a pocket of skin in which the pulse generator is housed. C63169 Pacing Problem 1439 FDA C54451 FDA Device Problem Code Hierarchy C62869 Poor Quality Image 1408 IMDRF:A090208 Monitor, Image Quality Poor Inadequate quality of an image or any visual representation displayed by the device, or output from the device. Inadequate quality of an image or any visual representation displayed by the device, or output from the device. C63088 Display or Visual Feedback Problem 1184 FDA C54451 FDA Device Problem Code Hierarchy C63183 Positioning Failure 1158 IMDRF:A150201 Deploy, Failure To Problem associated with the inability of the device to be positioned in a specified location. Problem associated with the inability of the medical device to be positioned in a specified location. C63034 Positioning Problem 3009 FDA C54451 FDA Device Problem Code Hierarchy C63034 Positioning Problem 3009 IMDRF:A1502 Problem associated with the movement of the device to an intended location. Problem associated with the movement of the device to an intended location. C63013 Activation, Positioning or Separation Problem 2906 FDA C54451 FDA Device Problem Code Hierarchy C62868 Power Conditioning Problem 1474 IMDRF:A191003 Problem associated with a momentary overpower/over voltage from the utility and electrical systems of user facilities; - Problem associated with inadequate power conditioning such as the presence of fluctuation, surges, spikes, dropouts, noise and other such undesirable transients. Problem associated with a momentary overpower/over voltage from the utility and electrical systems of user facilities; or inadequate power conditioning such as the presence of fluctuation, surges, spikes, dropouts, noise and other such undesirable transients. C63217 Electrical Power Problem 2925 FDA C54451 FDA Device Problem Code Hierarchy C63025 Power Problem 3010 IMDRF:A0708 Problem associated with the energy to operate the device. Problem associated with the energy to operate the device. C63007 Electrical /Electronic Property Problem 1198 FDA C54451 FDA Device Problem Code Hierarchy C62866 Precipitate in Device or device Ingredient 1478 IMDRF:A030203 Precipitate Problem associated with the separation of solid particles from a liquid as the result of a chemical or physical change. Problem associated with the separation of solid particles from a liquid as the result of a chemical or physical change. C62982 Device Ingredient or Reagent Problem 2910 FDA C54451 FDA Device Problem Code Hierarchy C62863 Premature Activation 1484 IMDRF:A150103 Premature System Activation Problem associated with early and unexpected activation of the device. Problem associated with early and unexpected activation of the device. C133631 Activation Problem 4042 FDA C54451 FDA Device Problem Code Hierarchy C62864 Premature Discharge of Battery 1057 IMDRF:A070504 Battery, Premature Discharge Of Battery discharging earlier than expected. Battery discharging earlier than expected. C63030 Battery Problem 2885 FDA C54451 FDA Device Problem Code Hierarchy C63315 Premature Elective Replacement Indicator 1483 IMDRF:A160601 Premature ERI Problems with the early or unexpected activation of the elective replacement indicator. Problems with the early or unexpected activation of the elective replacement indicator. C62865 Premature Indicator Activation 3011 FDA C54451 FDA Device Problem Code Hierarchy C63320 Premature End-of-Life Indicator 1480 IMDRF:A160602 Premature EOL Problem with the early or unexpected activation of the end-of-life indicator. Problem with the early or unexpected activation of the end-of-life indicator. C62865 Premature Indicator Activation 3011 FDA C54451 FDA Device Problem Code Hierarchy C62865 Premature Indicator Activation 3011 IMDRF:A1606 Problems with the activation of a protective measure indicator earlier than expected. Problems with the activation of a protective measure indicator earlier than expected. C62932 Protective Measures Problem 3015 FDA C54451 FDA Device Problem Code Hierarchy C133634 Premature Separation 4045 IMDRF:A150303 Problem associated with an early and unexpected detachment or separation of the device from the system. Problem associated with an early and unexpected detachment or separation of the device from the system. C133632 Separation Problem 4043 FDA C54451 FDA Device Problem Code Hierarchy C62934 Pressure Problem 3012 IMDRF:A1411 Problem associated with the application of a force either internal or external to device that compromises the flow of fluid or gas. Problem associated with the application of a force either internal or external to device that compromises the flow of fluid or gas. C63075 Infusion or Flow Problem 2964 FDA C54451 FDA Device Problem Code Hierarchy C133629 Priming Problem 4040 IMDRF:A1414 Problem associated with the preparation of the device to begin pumping. Problem associated with the preparation of the device to begin pumping. C63075 Infusion or Flow Problem 2964 FDA C54451 FDA Device Problem Code Hierarchy C63163 Problem with Removal of Enzymatic Cleaner 1213 IMDRF:A180304 Enzymatic Cleaner, Failure To Remove Enzymatic cleaner was not removed properly. Enzymatic cleaner was not removed properly from the device. C63099 Device Reprocessing Problem 1091 FDA C54451 FDA Device Problem Code Hierarchy C67507 Problem with Software Installation 3013 IMDRF:A110207 Problem associated with installing the device software in a manner that allows full functioning of the device. Source of installation could be manufacturer or user. Problem associated with installing a medical device software in a manner that allows full functioning of a medical device. Source of installation could be manufacturer or user. C63305 Application Program Problem 2880 FDA C54451 FDA Device Problem Code Hierarchy C63156 Problem with Sterilization 1596 IMDRF:A180305 Sterilization Failure|Sterilization, Inadequate Device was not sterilized properly during reprocessing. Device was not sterilized properly during reprocessing. C63099 Device Reprocessing Problem 1091 FDA C54451 FDA Device Problem Code Hierarchy C62948 Product Quality Problem 1506 IMDRF:A0201 Device Or Device Component Quality Issue|Quality, Unsatisfactory Or Poor Problem associated with an inherent device characteristic that is not satisfactory as specified or delivered. A difficulty with the quality of part of the device or the device itself. C63041 Manufacturing, Packaging or Shipping Problem 2975 FDA C54451 FDA Device Problem Code Hierarchy C133625 Program or Algorithm Execution Failure 4036 IMDRF:A110303 Problem associated with the failure of a program or algorithm to execute. Sudden/unexpected interruption to a program's execution. Problem associated with the failure of a program or algorithm to execute. Sudden /unexpected interruption to a program's execution. C133593 Program or Algorithm Execution Problem 4033 FDA C54451 FDA Device Problem Code Hierarchy C133593 Program or Algorithm Execution Problem 4033 IMDRF:A1103 Problem associated with execution problems relating to program or algorithm. Problem associated with execution problems relating to program or algorithm. C63269 Computer Software Problem 1112 FDA C54451 FDA Device Problem Code Hierarchy C62932 Protective Measures Problem 3015 IMDRF:A16 Problem associated with any deviations from the documented specifications of the device that relate to the implemented and inherited design features specific to devices used for reducing risks to patient or caregiver or maintaining risks within specified levels. Problem associated with any deviations from the documented specifications of the device that relate to the implemented and inherited design features specific to devices used for reducing risks to patient or caregiver or maintaining risks within specified levels. C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C62860 Pumping Problem 3016 IMDRF:A1412 Problem associated with pump performance deviating from specifications in a way to compromise flow or infusion. Problem associated with pump performance deviating from specifications in a way to compromise flow or infusion. C63075 Infusion or Flow Problem 2964 FDA C54451 FDA Device Problem Code Hierarchy C62859 Pumping Stopped 1503 IMDRF:A141204 Pumping, Stopped Unexpected /unintended cessation of pump. Unexpected /unintended cessation of pump. C62860 Pumping Problem 3016 FDA C54451 FDA Device Problem Code Hierarchy C62857 Radiation Leak 1357 IMDRF:A050404 Leak, Radiation Escape of radiation (energy in the form of waves or subatomic particles, especially those that cause ionization) through containment structures, leading to unintended exposure. Escape of radiation (energy in the form of waves or subatomic particles, especially those that cause ionization) through containment structures, leading to unintended exposure. C63058 Leak / Splash 1354 FDA C54451 FDA Device Problem Code Hierarchy C133569 Radiation Output Failure 4027 IMDRF:A090501 Problem associated with the absence of radiation output from radiological or diagnostic devices. Problem associated with the absence of radiation output from radiological or diagnostic devices. C133562 Radiation Output Problem 4026 FDA C54451 FDA Device Problem Code Hierarchy C133562 Radiation Output Problem 4026 IMDRF:A0905 Problem with the device's intended output of radiation. Problem with the device's intended output of radiation. C62941 Output Problem 3005 FDA C54451 FDA Device Problem Code Hierarchy C72892 Radiation Overexposure 3017 IMDRF:A090502 Problem associated with excessive radiation emitted from radiological or diagnostic devices. Problem associated with excessive radiation emitted from radiological or diagnostic devices. C133562 Radiation Output Problem 4026 FDA C54451 FDA Device Problem Code Hierarchy C72893 Radiation Underexposure 3018 IMDRF:A090503 Problem associated with too little radiation emitted from radiological or diagnostic devices. Problem associated with too little radiation emitted from radiological or diagnostic devices. C133562 Radiation Output Problem 4026 FDA C54451 FDA Device Problem Code Hierarchy C62855 Radiofrequency Interference (RFI) 2314 IMDRF:A072002 Problem associated with the degradation of the reception of a wanted signal caused by RF disturbance. Problem associated with the degradation of the reception of a wanted signal caused by RF disturbance. C63215 Electromagnetic Compatibility Problem 2927 FDA C54451 FDA Device Problem Code Hierarchy C62854 Reflux within Device 1522 IMDRF:A140507 Reflux Problem associated with partial backflow, compromising the device's flow output. Problem associated with partial backflow, compromising the device's flow output. C63110 Improper Flow or Infusion 2954 FDA C54451 FDA Device Problem Code Hierarchy C62852 Reset Problem 3019 IMDRF:A1605 Problem associated with setting a variable, register, or other storage location back to a prescribed state. Problem associated with setting a variable, register, or other storage location back to a prescribed state. C62932 Protective Measures Problem 3015 FDA C54451 FDA Device Problem Code Hierarchy C62850 Residue After Decontamination 2325 IMDRF:A180306 Residue Problem associated with the decontamination process not adequately removing unwanted visible soil, foreign material, or organism deposits. Problem associated with the decontamination process not adequately removing unwanted visible soil, foreign material, or organism deposits. C63099 Device Reprocessing Problem 1091 FDA C54451 FDA Device Problem Code Hierarchy C62849 Restricted Flow rate 1248 IMDRF:A140508 Flowrate, Restricted Problem associated with flow rate. Flow volume delivered over time is not reaching intended flow rate. Problem associated with flow rate. Flow volume delivered over time is not reaching intended flow rate. C63110 Improper Flow or Infusion 2954 FDA C54451 FDA Device Problem Code Hierarchy C62929 Retraction Problem 1536 IMDRF:A0510 Retract, Failure To Problem associated with drawing back the device to an intended location. Problem associated with drawing back the device to an intended location. C62961 Mechanical Problem 1384 FDA C54451 FDA Device Problem Code Hierarchy C62846 Scratched Material 3020 IMDRF:A0415 Scratched Problem associated with an undesirable shallow cut or narrow groove in the surface of the device materials. Problem associated with an undesirable shallow cut or narrow groove in the surface of the device materials. C62968 Material Integrity Problem 2978 FDA C54451 FDA Device Problem Code Hierarchy C62844 Self-Activation or Keying 1557 IMDRF:A150104 Self-Activation/Keying Problem associated with the unintended activation of the device, or the device having been unexpectedly turned on during use. Problem associated with the unintended activation of the device, or a device having been unexpectedly turned on during use. C133631 Activation Problem 4042 FDA C54451 FDA Device Problem Code Hierarchy C63065 Sensing Intermittently 1558 IMDRF:A070911 Problem with the device receiving an incoming signal on an intermittent basis when expected to be continuous. Problem with the device receiving an incoming signal on an intermittent basis when expected to be continuous. C63238 Device Sensing Problem 2917 FDA C54451 FDA Device Problem Code Hierarchy C63159 Separation Failure 2547 IMDRF:A150301 Separate, Failure To Problem associated with the device or one of its components failing to detach or separate as intended. Problem associated with the device or one of its components failing to detach or separate as intended. C133632 Separation Problem 4043 FDA C54451 FDA Device Problem Code Hierarchy C133632 Separation Problem 4043 IMDRF:A1503 Problem associated with the detachment or separation of the device. Problem associated with the detachment or separation of device. C63013 Activation, Positioning or Separation Problem 2906 FDA C54451 FDA Device Problem Code Hierarchy C133514 Sharp Edges 4013 IMDRF:A051102 The device has undesirable sharp edges which can cause harm or damage. The device has undesirable sharp edges which can cause harm or damage. C62923 Structural Problem 2506 FDA C54451 FDA Device Problem Code Hierarchy C62842 Shielding Failure 1568 IMDRF:A1607 Problem associated with the device inability to act as a barrier for absorption of radiation energy in X-rays, gamma rays, etc. Problem associated with the device inability to act as a barrier for absorption of radiation energy in X-rays, gamma rays, etc. C62932 Protective Measures Problem 3015 FDA C54451 FDA Device Problem Code Hierarchy C62925 Shipping Damage or Problem 1570 IMDRF:A0207 Problem associated with shipping damage or problem prior to the use of the device. Problem associated with shipping damage or problem prior to the use of the device. C63041 Manufacturing, Packaging or Shipping Problem 2975 FDA C54451 FDA Device Problem Code Hierarchy C62841 Short Fill 1575 IMDRF:A140303 Insufficient filling of a device. For complete failure to fill use "inability to auto-fill". For insufficient filling use "short fill". For inconsistent filling - use "Volume Accuracy Problem". Insufficient filling of a device. For complete failure to fill use inability to auto-fill. For insufficient filling use short fill. For inconsistent filling - use Volume Accuracy Problem. C63144 Filling Problem 1233 FDA C54451 FDA Device Problem Code Hierarchy C63300 Signal Artifact 1036 IMDRF:A090801 Problem associated with impurities or interference in a signal (e.g. ECG artifact). Problem associated with impurities or interference in a signal (e.g. ECG artifact). C62848 Incorrect, Inadequate or Imprecise Result or Readings 1535 FDA C54451 FDA Device Problem Code Hierarchy C63003 Smoking 1585 IMDRF:A1009 Smoke Problem associated with a cloud of vapor or gas generated from the device, generally associated after a fire or a burn. Problem associated with a cloud of vapor or gas generated from the device, generally associated after a fire or a burn. C62922 Temperature Problem 3022 FDA C54451 FDA Device Problem Code Hierarchy C62838 Solder Joint Fracture 2324 IMDRF:A040104 Problem associated with undesired damage or breakage in a solder joint of materials used in the device construction. Problem associated with undesired damage or breakage in a solder joint of materials used in the device construction. C62973 Break 1069 FDA C54451 FDA Device Problem Code Hierarchy C62837 Sparking 2595 IMDRF:A0704 Problem associated with a flash of light related to an electrical discharge into a normally non conductive medium, such as air. Not associated with a discharge between two conductive surfaces. Problem associated with a flash of light related to an electrical discharge into a normally non conductive medium, such as air. Not associated with a discharge between two conductive surfaces. C63007 Electrical /Electronic Property Problem 1198 FDA C54451 FDA Device Problem Code Hierarchy C62835 Stretched 1601 IMDRF:A040611 Material Stretched Problem associated with an increase or elongation in a materials' dimension. Problem associated with an increase or elongation in a materials' dimension. C63248 Material Deformation 2976 FDA C54451 FDA Device Problem Code Hierarchy C62923 Structural Problem 2506 IMDRF:A0511 Structural Failure Problem associated with the basic physical construction or physical make up of the device. Problem associated with the basic physical construction or physical make up of the device. C62961 Mechanical Problem 1384 FDA C54451 FDA Device Problem Code Hierarchy C133628 Suction Failure 4039 IMDRF:A141303 Problem associated with the complete inability to provide suction. Problem associated with the complete inability to provide suction. C62833 Suction Problem 2170 FDA C54451 FDA Device Problem Code Hierarchy C62833 Suction Problem 2170 IMDRF:A1413 Suction Failure Problem 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. Problem associated with suction equipment, which may be a manual, electrical, vacuum or pressure source operated to evacuate and remove undesired substances (air, gas, fluid, or particulates) via tubing and collection bag. C63075 Infusion or Flow Problem 2964 FDA C54451 FDA Device Problem Code Hierarchy C133547 Tactile Prompts / Feedback 4022 IMDRF:A0903 Problem with any deviation from the documented specifications of the device that relate to tactile feedback. e.g. device vibrational prompt. Problem with any deviation from the documented specifications of the device that relates to tactile feedback, e.g. device vibrational prompt. C62941 Output Problem 3005 FDA C54451 FDA Device Problem Code Hierarchy C62831 Tear, Rip or Hole in Device Packaging 2385 IMDRF:A020504 Packaging, Tears, Rips, Holes In Problem associated with packaging damage (tear, rip or hole) prior to the use of the device. Problem associated with packaging damage (tear, rip or hole) prior to the use of the device. C62939 Packaging Problem 3007 FDA C54451 FDA Device Problem Code Hierarchy C62830 Telemetry Discrepancy 1629 IMDRF:A1304 Problem associated with variability of the transmission of telemetry signals. Problem associated with variability of the transmission of telemetry signals. C63271 Communication or Transmission Problem 2896 FDA C54451 FDA Device Problem Code Hierarchy C62922 Temperature Problem 3022 IMDRF:A10 Problem associated with the device producing unintended temperatures. Problem associated with the device producing unintended temperatures. C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C62828 Therapeutic or Diagnostic Output Failure 3023 IMDRF:A090406 Problem associated with the failure of the device to deliver the output required for treatment or identification of a disease. Problem associated with the failure of the device to deliver the output required for treatment or identification of a disease. C63002 Energy Output Problem 1431 FDA C54451 FDA Device Problem Code Hierarchy C62858 Therapy Delivered to Incorrect Body Area 1508 IMDRF:A090407 Problem associated with the device causing unintended therapeutic action to an area of the body other than the intended area. Problem associated with the device causing unintended therapeutic action to an area of the body other than the intended area. C63002 Energy Output Problem 1431 FDA C54451 FDA Device Problem Code Hierarchy C63286 Thermal Decomposition of Device 1071 IMDRF:A1006 Burn|Burned|Burnt Problems associated with a discoloration or destruction as a result of thermal decomposition of the device. Problems associated with a discoloration or destruction as a result of thermal decomposition of the device. C62922 Temperature Problem 3022 FDA C54451 FDA Device Problem Code Hierarchy C63138 Tidal Volume Fluctuations 1634 IMDRF:A140509 Problem associated with the amount of gas that is inspired and expired during one respiratory cycle. Problem associated with the amount of gas that is inspired and expired during one respiratory cycle. C63110 Improper Flow or Infusion 2954 FDA C54451 FDA Device Problem Code Hierarchy C62826 Unable to Obtain Readings 1516 IMDRF:A090811 Readings, Unable To Obtain The device does not provide or display a valid reading. The device does not provide or display a valid reading. C62848 Incorrect, Inadequate or Imprecise Result or Readings 1535 FDA C54451 FDA Device Problem Code Hierarchy C63259 Unauthorized Access to Computer System 3025 IMDRF:A110502 Problem 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. Problem associated with an access that was not permitted to the computer system that may lead to modification of program, corruption of data, or and break in network security. This concept is closely associated with computer integrity which is the degree to which a system or component prevents unauthorized access to, or modification of, computer programs or data. C64348 Computer System Security Problem 2899 FDA C54451 FDA Device Problem Code Hierarchy C133644 Unclear Information 4052 IMDRF:A210104 Problem associated with ambiguous, confused information. Problem associated with ambiguous, confusing information. C62976 Device Markings / Labelling Problem 2911 FDA C54451 FDA Device Problem Code Hierarchy C62822 Under-Sensing 1661 IMDRF:A070910 Problem related to failure of the device to properly detect intrinsic cardiac activity and respond appropriately. Problem related to failure of the device to properly detect intrinsic cardiac activity and respond appropriately. C63238 Device Sensing Problem 2917 FDA C54451 FDA Device Problem Code Hierarchy C133544 Unexpected Shutdown 4019 IMDRF:A0719 Problem associated with the device unexpectedly powering down. Problem associated with the device unexpectedly powering down. C63007 Electrical /Electronic Property Problem 1198 FDA C54451 FDA Device Problem Code Hierarchy C62821 Unexpected Therapeutic Results 1631 IMDRF:A0909 Therapeutic Results, Unexpected Problem associated with the use of the device for therapeutic purposes. Problem associated with the use of a medical device for therapeutic purposes. C62941 Output Problem 3005 FDA C54451 FDA Device Problem Code Hierarchy C133571 Unexpected/Unintended Radiation Output 4028 IMDRF:A090504 Device-emitted radiation when it was not supposed to. This applies to devices which are intended to emit radiation, and the radiation being emitted from the correct part of the device, but at an incorrect time. Use "radiation leak" if the device emits radiation which should never have been emitted, or from a location from which it should never be emitted. Device-emitted radiation when it was not supposed to. This applies to devices which are intended to emit radiation, and the radiation being emitted from the correct part of the device, but at an incorrect time. C133562 Radiation Output Problem 4026 FDA C54451 FDA Device Problem Code Hierarchy C133594 Unintended Application Program Shut Down 4032 IMDRF:A110208 Problem associated with an unintended shut down by malfunction of the application program. Problem associated with an unintended shut down by malfunction of the application program. C63305 Application Program Problem 2880 FDA C54451 FDA Device Problem Code Hierarchy C62819 Unintended Collision 1429 IMDRF:A051205 Collision, Unintended Problem associated with the device impacting with another object. Problem associated with the device impacting with another object. C62814 Unintended Movement 3026 FDA C54451 FDA Device Problem Code Hierarchy C133636 Unintended compatibility 4047 IMDRF:A1704 Problem associated with the ability of two or more devices which are intended to be incompatible but are able to work or fit together. Problem associated with the ability of two or more devices which are intended to be incompatible but are able to work or fit together. C62983 Compatibility Problem 2960 FDA C54451 FDA Device Problem Code Hierarchy C62817 Unintended Ejection 1234 IMDRF:A050302 Film Cartridge Ejection, Unintended Problem associated with unexpected discharge of the device from expected location includes but not limited to the device such as clip appliers, film cartridge, staples. Problem associated with unexpected discharge of the device from expected location includes but not limited to the device such as clip appliers, film cartridge, staples. C133510 Ejection Problem 4009 FDA C54451 FDA Device Problem Code Hierarchy C133527 Unintended Electrical Shock 4018 IMDRF:A0714 The device delivers unintended electrical shock. Unintended defibrillation shock should be coded as "Inappropriate Shock" code number A071302. The device delivers unintended electrical shock. C63007 Electrical /Electronic Property Problem 1198 FDA C54451 FDA Device Problem Code Hierarchy C62814 Unintended Movement 3026 IMDRF:A05012 Problem associated with an undesired movement of the device, which may be related to the device- malfunction, misdiagnosis, or mistreatment. Movement of the device to an unintended location within the body. C62961 Mechanical Problem 1384 FDA C54451 FDA Device Problem Code Hierarchy C62818 Unintended power up 1162 IMDRF:A070804 Device Energization, Unintended|Unintended Device Energization Problem associated with the device turning on when not intended. Problem associated with the device turning on when not intended. C63025 Power Problem 3010 FDA C54451 FDA Device Problem Code Hierarchy C62813 Unintended System Motion 1430 IMDRF:A051206 System Motion, Unintended Problem associated with any motion of the system or components that was not initiated by the user. Problem associated with any motion of the system or components that was not initiated by the user. C62814 Unintended Movement 3026 FDA C54451 FDA Device Problem Code Hierarchy C62811 Unraveled Material 1664 IMDRF:A040508 Problem due to the undesired unravelling of material (e.g. disentangled, unwound etc.). Problem due to the device's undesired unravelling of material (e.g. disentangled, unwound etc.). C62970 Degraded 1153 FDA C54451 FDA Device Problem Code Hierarchy C62810 Unsealed Device Packaging 1444 IMDRF:A020503 Packaging, Unsealed Problem associated with the loss of packaging seal. Problem associated with the device's loss of packaging seal. C62939 Packaging Problem 3007 FDA C54451 FDA Device Problem Code Hierarchy C62809 Unstable 1667 IMDRF:A051207 Problem associated with the mechanical stability of the device. Problem associated with the mechanical stability of a device. C62814 Unintended Movement 3026 FDA C54451 FDA Device Problem Code Hierarchy C95876 Unstable Capture Threshold 3269 IMDRF:A070104 Capture Threshold, Unstable Problem with the amount of output energy needed to cause cardiac depolarization being unstable. Problem with the amount of output energy needed to cause cardiac depolarization being unstable. C63027 Capturing Problem 2891 FDA C54451 FDA Device Problem Code Hierarchy C63318 Use of Device Problem 1670 IMDRF:A23 Device, Incorrect Care/Use Of Problem associated with failure to process, service, or operate the device according to the manufacturer's recommendations or recognized best practices. Problem associated with failure to process, service, or operate the device according to the manufacturer's recommendations or recognized best practices. C54451 FDA Device Problem Code Hierarchy FDA C54451 FDA Device Problem Code Hierarchy C63264 Use of Incorrect Control Settings 1126 IMDRF:A2302 Control Settings Incorrect Problem 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. Problem 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 Use of Device Problem 1670 FDA C54451 FDA Device Problem Code Hierarchy C62807 Ventilation Problem in Device Environment 3027 IMDRF:A1906 Problem associated with the circulation of fresh air in the immediate atmosphere in which the device is being used. Problem associated with the circulation of fresh air in the immediate atmosphere in which the device is being used. C63209 Environmental Compatibility Problem 2929 FDA C54451 FDA Device Problem Code Hierarchy C62806 Vibration 1674 IMDRF:A051208 Problem associated with the undesirable mechanical oscillation. Problem associated with the undesirable mechanical oscillation in a device. C62814 Unintended Movement 3026 FDA C54451 FDA Device Problem Code Hierarchy C62861 Visual Prompts will not Clear 2281 IMDRF:A090209 Problem with visual messages which continue to be displayed on / by the device after the appropriate action has been taken. Problem with visual messages which continue to be displayed on/by the device after the appropriate action has been taken. C63088 Display or Visual Feedback Problem 1184 FDA C54451 FDA Device Problem Code Hierarchy C62805 Volume Accuracy Problem 1675 IMDRF:A140304 Volume Accuracy Inconsistent filling of a device. This describes a problem which is observed to vary between overfilling and under filling, and may be intermittent. Use "Overfill" or "Short Fill" if problem is consistent. Inconsistent filling of a device. This describes a problem which is observed to vary between overfilling and under filling, and may be intermittent. Use Overfill or Short Fill if problem is consistent. C63144 Filling Problem 1233 FDA C54451 FDA Device Problem Code Hierarchy C104820 Wireless Communication Problem 3283 IMDRF:A1305 Problems 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. Problems 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. C63271 Communication or Transmission Problem 2896 FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C139525 Adverse Event Related to Commutability 4312 The adverse event occurred because the material being used to calibrate or assess IVD performance did not have similar properties to those of human samples, leading to inappropriate bias and erroneous results. Examples of materials include: reference materials, calibrators, proficiency testing samples. The adverse event occurred because the material being used to calibrate or assess IVD performance did not have similar properties to those of human samples, leading to inappropriate bias and erroneous results. Examples of materials include: reference materials, calibrators, proficiency testing samples. C139470 Cause Cannot be Traced to Device 4310 FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C91872 Adverse Event Related to Patient Condition 50 An existing condition or disease is demonstrably responsible for the adverse event and use of the device has neither caused nor otherwise influenced this condition/disease-related adverse event. An existing condition or disease is demonstrably responsible for the adverse event and use of the device has neither caused nor otherwise influenced this condition/disease-related adverse event. C139470 Cause Cannot be Traced to Device 4310 FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C139526 Adverse Event Related to Procedure 4311 The adverse event occurred during the procedure and the device had no influence on event. The adverse event occurred during the procedure and the device had no influence on event. C139470 Cause Cannot be Traced to Device 4310 FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C139469 Appropriate Term/Code Not Available 4316 The concluded cause is not adequately described by any other term. Note: This code must not be used unless there is no other feasible code. The preferred term should be documented when submitting an adverse event report. This information will be used to determine if a new term should be added to the code table. The concluded cause is not adequately described by any other term. C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C139470 Cause Cannot be Traced to Device 4310 The adverse event that occurred is not attributable to a device. The adverse event that occurred is not attributable to a device. C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C139471 Cause Not Established 4315 The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event. The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event. C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C139472 Cause Traced to Component Failure 4307 Expected or random component failure without any design or manufacturing issue. Expected or random component failure without any design or manufacturing issue. C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C91869 Cause Traced to Device Design 12 Problems traced to the design specifications (e.g. in the requirements, testing processes, hazard analysis, implementation strategy). Problems traced to the design specifications (e.g. in the requirements, testing processes, hazard analysis, implementation strategy). C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C139473 Cause Traced to Environment 4309 Problems caused by exposure to environmental conditions outside the expected range. Problems caused by exposure to environmental conditions outside the expected range. C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C91877 Cause Traced to Infrastructure 21 Problems traced to underlying framework, systems, and processes at the healthcare facility or other point of use (e.g. as building power supply, network, oxygen systems). The undesirable presence of living organisms such as bacteria, fungi, or viruses or their products (enzymes or toxins). C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C91892 Cause Traced to Intentional Off-Label, Unapproved, or Contraindicated Use 24 Problems traced to the intentional use of the device in an unapproved procedure, for an unapproved patient, or for which it is contraindicated, or not listed on the label. Problems traced to the intentional use of the device in an unapproved procedure, for an unapproved patient, or for which it is contraindicated, or not listed on the label. C91874 Cause Traced to User 19 FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C91879 Cause Traced to Labeling 57 Problems that occur as the result of problems with the labeling (including package inserts, instruction manuals, instructions for use). Problems that occur as the result of problems with the labeling (including package inserts, instruction manuals, instructions for use). C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C91880 Cause Traced to Maintenance 51 Problems traced to improper routine or preventative maintenance. Problems traced to improper routine or preventative maintenance. C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C91885 Cause Traced to Manufacturing 25 A defect in the processes or systems used in the manufacture of the device. Examples include problems within the change control, production, or quality control processes. A defect in the processes or systems used in the manufacture of the device. Examples include problems within the change control, production, or quality control processes. C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C91889 Cause Traced to Training 27 Problems caused by inadequate training. Problems caused by inadequate training. C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C139474 Cause Traced to Transport/Storage 4308 Problems traced to the inappropriate transport or storage of the device. Problems traced to the inappropriate transport or storage of the device. C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C91874 Cause Traced to User 19 C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C91868 Conclusion Not Yet Available 11 A conclusion has yet to be established as the investigation is incomplete. Do not use this code if the investigation is complete. A conclusion has yet to be established as the investigation is incomplete. C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C139476 Design Change Validation Inadequate 4306 Problems traced to inadequate or lack of validation of design changes of the device leading to malfunction or unintended properties of the device including possible hazards for persons using the device. Problems traced to inadequate or lack of validation of design changes of the device leading to malfunction or unintended properties of the device including possible hazards for persons using the device. C91869 Cause Traced to Device Design 12 FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C139477 Design Inadequate for Purpose 4301 Problems traced to design/design features of the device that do not support or interfere with the intended purpose of the device. Problems traced to design/design features of the device that do not support or interfere with the intended purpose of the device. C91869 Cause Traced to Device Design 12 FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C92048 End of Life Problem Identified 133 Problems traced to the device reaching the end of its useful life. Problems traced to the device reaching the end of its useful life. C91874 Cause Traced to User 19 FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C91873 Failure To Follow Instructions 18 Problems traced to the user not following the manufacturer's instructions. Problems traced to the user not following the manufacturer's instructions. C91874 Cause Traced to User 19 FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C139475 Falsified Device 4314 Devices that deliberately and/or fraudulently misrepresent their identity, composition or source. Devices that deliberately and/or fraudulently misrepresent their identity, composition or source. C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C139478 Human Factors Engineering - Device Difficult to Assemble 4303 Problems traced to inadequate design of the component parts and/or assembly steps resulting in the device not being able to be assembled correctly. Problems traced to inadequate design of the component parts and/or assembly steps resulting in the device not being able to be assembled correctly. C91869 Cause Traced to Device Design 12 FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C139479 Human Factors Engineering - Device Difficult to Operate 4302 Problems traced to inappropriate and/or inadequate assessment and engineering design of the device to accommodate how or where the device will be used. Problems traced to inappropriate and/or inadequate assessment and engineering design of the device to accommodate how or where the device will be used. C91869 Cause Traced to Device Design 12 FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C139480 Human Factors Engineering - Device Difficult to Reprocess 4304 Problems traced to inadequate design of the reprocessing steps and/or the device resulting in the device remaining unclean. Problems traced to inadequate design of the reprocessing steps and/or the device resulting in the device remaining unclean. C91869 Cause Traced to Device Design 12 FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C91878 Known Inherent Risk of Device 22 Reported adverse event known and documented in the labeling (including both short or long term known complications or adverse reactions). Reported adverse event known and documented in the labeling (including both short or long term known complications or adverse reactions). C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C91881 Manufacturing Deficiency 23 Problems traced to manufacturing process. Problems traced to manufacturing process. C91885 Cause Traced to Manufacturing 25 FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C139481 Missing or Inadequate Safety Measures 4305 Problems traced to inadequate design or complete lack of safety measures leading to device malfunction or unintended properties of the device including possible hazards for persons using the device. Problems traced to inadequate design or complete lack of safety measures leading to device malfunction or unintended properties of the device including possible hazards for persons using the device. C91869 Cause Traced to Device Design 12 FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C91894 No Problem Detected 67 The device complaint or problem cannot be confirmed. The device complaint or problem cannot be confirmed. C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C92099 Quality Control Deficiency 143 Problems traced to the failure to maintain or establish techniques for controlling and verifying the product specifications (including materials used) identified by the manufacturer himself. Problems traced to the failure to maintain or establish techniques for controlling and verifying the product specifications (including materials used) identified by the manufacturer himself. C91885 Cause Traced to Manufacturing 25 FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C91893 Reuse of Single Use Device 26 Problems traced to the use of the device more than once when it is designed for only one use. Problems traced to the use of the device more than once when it is designed for only one use. C91874 Cause Traced to User 19 FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C139482 Sabotage or Intentional Misuse 4313 Problems occurred because of willful damage or reckless misuse. This term indicates that there was an apparent intent to cause damage or injury. Problems occurred because of willful damage or reckless misuse. This term indicates that there was an apparent intent to cause damage or injury. C91874 Cause Traced to User 19 FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C92106 Shelf Life/Expiration Date Exceeded 192 A device that has exceeded the period of time/date recommended by the manufacturer for storing the device without a degradation in quality. A device that has exceeded the period of time/date recommended by the manufacturer for storing the device without a degradation in quality. C91874 Cause Traced to User 19 FDA C91802 FDA Manufacturer Evaluation Conclusion Code Hierarchy C91895 Unintended Use Error Caused or Contributed to Event 61 The interaction between the user and device, or sample, caused or contributed to the error. This includes unintended inappropriate use of the device and incorrect sample preparation. The interaction between the user and device, or sample, caused or contributed to the error. This includes unintended inappropriate use of the device and incorrect sample preparation. C91874 Cause Traced to User 19 FDA C91800 FDA Manufacturer Evaluation Method Code Hierarchy C139458 Analysis of Data Provided by User/Third Party 4112 The investigation involved the analysis of relevant data provided by the user (e.g. healthcare professional, patient, clinical engineer) or a third party (e.g. testing facility) in view of supporting the identification of possible causes for the adverse event. The investigation involved the analysis of relevant data provided by the user (e.g. healthcare professional, patient, clinical engineer) or a third party (e.g. testing facility) in view of supporting the identification of possible causes for the adverse event. C91800 FDA Manufacturer Evaluation Method Code Hierarchy FDA C91800 FDA Manufacturer Evaluation Method Code Hierarchy C91978 Analysis of Production Records 3331 The investigation involved the analysis of relevant production records in view of supporting the identification of possible causes for the adverse event. The investigation involved the analysis of relevant production records in view of supporting the identification of possible causes for the adverse event. C91800 FDA Manufacturer Evaluation Method Code Hierarchy FDA C91800 FDA Manufacturer Evaluation Method Code Hierarchy C139457 Communication/Interviews 4111 The investigation involved communication/interviews (either interpersonal or through technical means, e.g. phone, e-mail) with persons close to the adverse event, e.g. healthcare professionals (doctors, nurses etc.), the affected patient(s) or other users including, where appropriate, relatives or others engaged in caring for the affected patient. The investigation involved communication/interviews (either interpersonal or through technical means, e.g. phone, e-mail) with persons close to the adverse event, e.g. healthcare professionals (doctors, nurses etc.), the affected patient(s) or other users including, where appropriate, relatives or others engaged in caring for the affected patient. C91800 FDA Manufacturer Evaluation Method Code Hierarchy FDA C91800 FDA Manufacturer Evaluation Method Code Hierarchy C139461 Device Discarded 4115 The actual device involved in the adverse event had been already discarded and thus irretrievably lost for testing. The actual device involved in the adverse event had been already discarded and thus irretrievably lost for testing. C91800 FDA Manufacturer Evaluation Method Code Hierarchy FDA C91800 FDA Manufacturer Evaluation Method Code Hierarchy C139463 Device Not Accessible for Testing 4117 The actual device involved in the adverse event is not readily accessible for testing (e.g. remains implanted in patient). The actual device involved in the adverse event is not readily accessible for testing (e.g. remains implanted in patient). C91800 FDA Manufacturer Evaluation Method Code Hierarchy FDA C91800 FDA Manufacturer Evaluation Method Code Hierarchy C139459 Device Not Manufactured by Reporting Manufacturer 4113 Further information was obtained which established that the manufacturer of the device involved was not the one to which it was initially attributed. Further information was obtained which established that the manufacturer of the device involved was not the one to which it was initially attributed. C91800 FDA Manufacturer Evaluation Method Code Hierarchy FDA C91800 FDA Manufacturer Evaluation Method Code Hierarchy C139460 Device Not Returned 4114 The actual device involved in the adverse event was not returned for testing despite requests by manufacturer. The actual device involved in the adverse event was not returned for testing despite requests by manufacturer. C91800 FDA Manufacturer Evaluation Method Code Hierarchy FDA C91800 FDA Manufacturer Evaluation Method Code Hierarchy C139455 Historical Data Analysis 4109 The investigation involved the analysis of historical adverse events data of the actual device involved in the adverse event and/or of products from the same and/or different batches/lots. The investigation involved the analysis of historical adverse events data of the actual device involved in the adverse event and/or of products from the same and/or different batches/lots. C91800 FDA Manufacturer Evaluation Method Code Hierarchy FDA C91800 FDA Manufacturer Evaluation Method Code Hierarchy C139462 Incomplete Device Returned 4116 The device was returned incompletely, lacking parts, components or accessories that would be required for appropriate testing and analysis of root causes. The device was returned incompletely, lacking parts, components or accessories that would be required for appropriate testing and analysis of root causes. C91800 FDA Manufacturer Evaluation Method Code Hierarchy FDA C91800 FDA Manufacturer Evaluation Method Code Hierarchy C139465 Insufficient Information Available 4119 The information available relating to the reported event is not sufficient to identify either the manufacturer, the device, or other essential information. This term indicates that no further investigation is possible. Do not use this code if further information is being sought, instead use ''Type of investigation not yet determined''. The information available relating to the reported event is not sufficient to identify either the manufacturer, the device, or other essential information. C91800 FDA Manufacturer Evaluation Method Code Hierarchy FDA C91800 FDA Manufacturer Evaluation Method Code Hierarchy C91896 Testing of Actual/Suspected Device 10 C91800 FDA Manufacturer Evaluation Method Code Hierarchy FDA C91800 FDA Manufacturer Evaluation Method Code Hierarchy C139448 Testing of Device from Other Lot/Batch Retained by Manufacturer 4102 The investigation employed relevant empirical testing of the device of another lot or batch than that of the suspected device in the reported adverse event in order to support the identification of possible causes for the adverse event. This includes devices without a lot/batch designation. Testing was performed using the device retained by the manufacturer (i.e. was not shipped). Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards. The investigation employed relevant empirical testing of the device of another lot or batch than that of the suspected device in the reported adverse event in order to support the identification of possible causes for the adverse event. This includes devices without a lot/batch designation. Testing was performed using the device retained by the manufacturer (i.e. was not shipped). Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards. C91800 FDA Manufacturer Evaluation Method Code Hierarchy FDA C91800 FDA Manufacturer Evaluation Method Code Hierarchy C139449 Testing of Device from Other Lot/Batch Returned from User 4103 The investigation employed relevant empirical testing of the device of another lot or batch than that of the suspected device in the reported adverse event in order to support the identification of possible causes for the adverse event. This includes devices without a lot/batch designation. The device was returned from the user. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the technical file. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards. The investigation employed relevant empirical testing of the device of another lot or batch than that of the suspected device in the reported adverse event in order to support the identification of possible causes for the adverse event. This includes devices without a lot/batch designation. The device was returned from the user. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the technical file. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards. C91800 FDA Manufacturer Evaluation Method Code Hierarchy FDA C91800 FDA Manufacturer Evaluation Method Code Hierarchy C91933 Testing of Device from Same Lot/Batch Retained by Manufacturer 11 C91800 FDA Manufacturer Evaluation Method Code Hierarchy FDA C91800 FDA Manufacturer Evaluation Method Code Hierarchy C139447 Testing of Device from Same Lot/Batch Returned from User 4101 The investigation employed relevant empirical testing of the device of the same lot or batch than that of the suspected device in the reported adverse event in order to support the identification of possible causes for the adverse event. The device was returned from the user. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards. The investigation employed relevant empirical testing of the device of the same lot or batch than that of the suspected device in the reported adverse event in order to support the identification of possible causes for the adverse event. The device was returned from the user. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards. C91800 FDA Manufacturer Evaluation Method Code Hierarchy FDA C91800 FDA Manufacturer Evaluation Method Code Hierarchy C139450 Testing of Model Variant 4104 The investigation employed relevant empirical testing of a model variant of the device involved in the reported adverse event in order to support the identification of possible causes for the adverse event through plausibility reasoning. A model variant is not identical to the actual device, but shares relevant characteristics with the device involved. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards. The investigation employed relevant empirical testing of a model variant of the device involved in the reported adverse event in order to support the identification of possible causes for the adverse event through plausibility reasoning. A model variant is not identical to the actual device, but shares relevant characteristics with the device involved. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards. C91800 FDA Manufacturer Evaluation Method Code Hierarchy FDA C91800 FDA Manufacturer Evaluation Method Code Hierarchy C139454 Testing of Patient Sample or Reference Material Using Competitor's Device 4108 The investigation employed relevant empirical testing of a patient sample or reference material using a competitor's device that is comparable to the device (usually an IVD) involved in the reported adverse event in order to support the identification of possible causes for the adverse event. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards. The investigation employed relevant empirical testing of a patient sample or reference material using a competitor's device that is comparable to the device (usually an IVD) involved in the reported adverse event in order to support the identification of possible causes for the adverse event. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards. C91800 FDA Manufacturer Evaluation Method Code Hierarchy FDA C91800 FDA Manufacturer Evaluation Method Code Hierarchy C139452 Testing of Patient Sample or Reference Material Using Manufacturer's Device 4106 The investigation employed relevant empirical testing of a patient sample or reference material using the device (usually an IVD) involved in the reported adverse event in order to support the identification of possible causes for the adverse event. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards. The investigation employed relevant empirical testing of a patient sample or reference material using the device (usually an IVD) involved in the reported adverse event in order to support the identification of possible causes for the adverse event. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards. C91800 FDA Manufacturer Evaluation Method Code Hierarchy FDA C91800 FDA Manufacturer Evaluation Method Code Hierarchy C139453 Testing of Patient Sample or Reference Material Using Reference Method 4107 The investigation employed relevant empirical testing of a patient sample or reference material using an appropriate reference method to the device (usually an IVD) involved in the reported adverse event in order to support the identification of possible causes for the adverse event. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards. The investigation employed relevant empirical testing of a patient sample or reference material using an appropriate reference method to the device (usually an IVD) involved in the reported adverse event in order to support the identification of possible causes for the adverse event. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards. C91800 FDA Manufacturer Evaluation Method Code Hierarchy FDA C91800 FDA Manufacturer Evaluation Method Code Hierarchy C139451 Testing of Raw/Starting Materials 4105 The investigation employed relevant empirical testing of the materials used in construction of the device involved in the reported adverse event in order to support the identification of possible causes for the adverse event. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards. The investigation employed relevant empirical testing of the materials used in construction of the device involved in the reported adverse event in order to support the identification of possible causes for the adverse event. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards. C91800 FDA Manufacturer Evaluation Method Code Hierarchy FDA C91800 FDA Manufacturer Evaluation Method Code Hierarchy C139456 Trend Analysis 4110 The investigation involved trend analysis of adverse event of the actual device involved in the adverse event and/or of products from the same and/or different batches/lots. It should be noted that trend analysis typically is not considered sufficient as a stand-alone method, but should be used in conjunction with other investigation methods for providing for instance complementary information. The investigation involved trend analysis of adverse event of the actual device involved in the adverse event and/or of products from the same and/or different batches/lots. It should be noted that trend analysis typically is not considered sufficient as a stand-alone method, but should be used in conjunction with other investigation methods for providing for instance complementary information. C91800 FDA Manufacturer Evaluation Method Code Hierarchy FDA C91800 FDA Manufacturer Evaluation Method Code Hierarchy C139464 Type of Investigation Not Yet Determined 4118 Details to determine the type of investigation are not yet available, but are being sought. Do not use this code if the investigation is complete. Details to determine the type of investigation are not yet available, but are being sought. Do not use this code if the investigation is complete. C91800 FDA Manufacturer Evaluation Method Code Hierarchy FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92026 Agglutination Problem 3202 The device affects the ability of the blood to clot which may be induced by chemical, mechanical, or thermal properties of the device. The device affects the ability of the blood to clot which may be induced by chemical, mechanical, or thermal properties of the device. C92060 Hematological Problem Identified 3255 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139506 Alarm System Problem Identified 4221 A system intended to warn of a potentially unsafe condition did not operate correctly. A system intended to warn of a potentially unsafe condition did not operate correctly. C92098 Protective System Problem Identified 3228 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139491 Ambient Light Problem Identified 4240 Device performance was affected by ambient light. This term applies to the direct effects of ambient light on the device, and to the user's ability to operate the device (e.g. to read device output). Device performance was affected by ambient light. This term applies to the direct effects of ambient light on the device, and to the user's ability to operate the device (e.g. to read device output). C92051 Environment Problem Identified 331 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139466 Appropriate Term/Code Not Available 4247 Problems is not adequately described by any other term. Note: This code must not be used unless there is no other feasible code. The preferred term should be documented when submitting an adverse event report. This information will be used to determine if a new term should be added to the code table. Problems is not adequately described by any other term. C91801 FDA Manufacturer Evaluation Result Code Hierarchy FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92028 Assembly Problem Identified 706 Problems that occurred because the device was assembled incorrectly. Problems that occurred because the device was assembled incorrectly. C92076 Manufacturing Process Problem Identified 170 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92029 Biocompatibility Problem Identified 3203 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) 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 Biological Problem Identified 3204 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92054 Biological Contamination 142 The undesirable presence of living organisms such as bacteria, fungi, or viruses or their products (enzymes or toxins). The undesirable presence of living organisms such as bacteria, fungi, or viruses or their products (enzymes or toxins). C92030 Biological Problem Identified 3204 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92030 Biological Problem Identified 3204 C91801 FDA Manufacturer Evaluation Result Code Hierarchy FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92031 Carcinogenic Problem 3205 The device's ability to trigger development of cancer. The device's ability to trigger development of cancer. C92057 Genotoxicity Problem Identified 3254 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139521 Change in Target Marker/Variant/ Mutant 4236 Problem due to change in target marker/variant/mutant which is not covered in the labelling. Problem due to change in target marker/variant/mutant which is not covered in the labeling. C139467 Patient Sample Problem 4233 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92102 Clinical Imaging Problem Identified 3230 Problems that occur with devices used for radiographic or imaging procedures e.g. CT scanners, magnetic resonance imaging. Problems that occur with devices used for radiographic or imaging procedures e.g. CT scanners, magnetic resonance imaging. C91801 FDA Manufacturer Evaluation Result Code Hierarchy FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92034 Communications Problem Identified 628 Devices that do not send or receive adequate signals (this speaks to the interoperability between devices). Devices that do not send or receive adequate signals (this speaks to the interoperability between devices). C92070 Interoperability Problem Identified 3213 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92035 Complement Activation Problem 3206 The device affects the body's ability to activate the complement system of the immune system, thereby interfering with the ability to clear pathogens. This may be caused by an interaction of the device with chemicals or materials. The device affects the body's ability to activate the complement system of the immune system, thereby interfering with the ability to clear pathogens. This may be caused by an interaction of the device with chemicals or materials. C92060 Hematological Problem Identified 3255 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92037 Conducted Interference 658 Problems related to 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). Problems related to 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 Electromagnetic Compatibility Problem Identified 197 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92038 Configuration Issue 3208 Problems due to change control or incorrect version, including regional requirements. Problems due to change control or incorrect version, including regional requirements. C92113 Software Problem Identified 104 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139492 Contamination of Environment by Device 4238 Operation of the device results in contamination of the nearby environment e.g. dust, dirt, smoke, heat or biological material. Operation of the device results in contamination of the nearby environment e.g. dust, dirt, smoke, heat or biological material. C92051 Environment Problem Identified 331 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92044 Current Leakage Problem 650 Problems related to leakage currents which may cause electric shock. These currents usually flow through the protective ground conductor. In its absence, these currents could flow from the device to the ground via the human body. Problems related to leakage currents which may cause electric shock. These currents usually flow through the protective ground conductor. In its absence, these currents could flow from the device to the ground via the human body. C92045 Electrical Problem Identified 120 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139483 Cytotoxicity Problem Identified 4201 The device was found to have an undesirable level of toxicity to living cells. The device was found to have an undesirable level of toxicity to living cells. C92030 Biological Problem Identified 3204 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92039 Data Compression Error 663 Data was lost or corrupted during the operation of reducing storage space or communication bandwidth. Data was lost or corrupted during the operation of reducing storage space or communication bandwidth. C92042 Design Error 110 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139514 Data Storage or Loss of Data 4215 Storage of data was unsuccessful in total or in part. Storage of data was unsuccessful in total or in part. C92113 Software Problem Identified 104 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92040 Deformation Problem 3211 Problems caused by changes in the shape or size of the device due to an applied force. This can be a result of tensile forces, compressive forces, shear, bending, tensile (pulling), or torsion. Problems caused by changes in the shape or size of the device due to an applied force. This can be a result of tensile forces, compressive forces, shear, bending, tensile (pulling), or torsion. C92120 Stress Problem Identified 3243 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92041 Degradation Problem Identified 135 Problems that occur when the device becomes worn, weakened, corroded, or broken down due to processes such as aging, permeation, and corrosion. Problems that occur when the device becomes worn, weakened, corroded, or broken down due to processes such as aging, permeation, and corrosion. C92078 Material and/or Chemical Problem Identified 174 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92042 Design Error 110 The device had faulty (incomplete or incorrect) software design. The device had faulty (incomplete or incorrect) software design. C92113 Software Problem Identified 104 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C91870 Device Difficult to Operate 13 Device problems including set-up, operation, and disassembly of equipment. Device problems including set-up, operation, and disassembly of equipment. C92088 Operational Problem Identified 114 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139485 Device Incorrectly Assembled During Reprocessing 4231 Incorrect assembly of the device following reprocessing. Incorrect assembly of the device following reprocessing. C139575 Device Incorrectly Reprocessed 4228 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139486 Device Incorrectly Cleaned During Reprocessing 4229 The cleaning procedure is not followed correctly or used inappropriate cleaning materials. The cleaning procedure is not followed correctly or used inappropriate cleaning materials. C139575 Device Incorrectly Reprocessed 4228 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139487 Device Incorrectly Disinfected/Sterilized During Reprocessing 4230 The disinfection/sterilization process was incorrect and/or the wrong products for disinfection/sterilization were used. The disinfection/sterilization process was incorrect and/or the wrong products for disinfection/sterilization were used. C139575 Device Incorrectly Reprocessed 4228 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139575 Device Incorrectly Reprocessed 4228 Problems associated with the failure to properly and adequately reprocess the device. Problems associated with the failure to properly and adequately reprocess the device. C92088 Operational Problem Identified 114 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92036 Device Migration 3207 A device that has moved from its original location due to external forces (e.g. stent or lead movement). A device that has moved from its original location due to external forces (e.g. stent or lead movement). C92079 Mechanical Problem Identified 180 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139494 Device Not Compatible With Another Device 4206 A device that malfunctions due to being used in combination with, or in the presence of, another device. A device that malfunctions due to being used in combination with, or in the presence of, another device. C92070 Interoperability Problem Identified 3213 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92043 Dust or Dirt Problem Identified 646 A device that experienced problems due to ingress, or coating, of dust or dirt. A device that experienced problems due to ingress, or coating, of dust or dirt. C92051 Environment Problem Identified 331 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92045 Electrical Problem Identified 120 Device-to-device or device-environment problem resulting from electromagnetic disturbances. C91801 FDA Manufacturer Evaluation Result Code Hierarchy FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139489 Electrical/Electronic Component Problem Identified 4203 The performance of an electrical or electronic component was found to be inadequate. The performance of an electrical or electronic component was found to be inadequate. C92045 Electrical Problem Identified 120 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92046 Electromagnetic Compatibility Problem Identified 197 Device-to-device or device-environment problem resulting from electromagnetic disturbances. Device-to-device or device-environment problem resulting from electromagnetic disturbances. C91801 FDA Manufacturer Evaluation Result Code Hierarchy FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92047 Electrostatic Discharge 648 Problems due to sudden and momentary bursts of electrical current flowing between two objects at different electrical potentials. Problems due to sudden and momentary bursts of electrical current flowing between two objects at different electrical potentials. C92046 Electromagnetic Compatibility Problem Identified 197 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92049 Endotoxin Contamination 3212 The undesirable presence of toxins associated with certain bacteria (e.g. gram negative bacteria). The undesirable presence of toxins associated with certain bacteria (e.g. gram negative bacteria). C92054 Biological Contamination 142 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92050 Energy Storage System Problem 131 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. 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. C92097 Power Source Problem Identified 3227 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92051 Environment Problem Identified 331 Problems that occurred due to factors within the environment e.g. dust, dirt, humidity, temperature. Problems that occurred due to factors within the environment e.g. dust, dirt, humidity, temperature. C91801 FDA Manufacturer Evaluation Result Code Hierarchy FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92061 Environmental Humidity Problem Identified 332 Device performance was affected by the humidity, or changes in humidity, of the environment in which it was used. Device performance was affected by the humidity, or changes in humidity, of the environment in which it was used. C92051 Environment Problem Identified 331 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139493 Environmental Pressure Problem Identified 4239 Device performance was affected by the pressure, or changes in pressure, of the environment in which it was used. Device performance was affected by the pressure, or changes in pressure, of the environment in which it was used. C92051 Environment Problem Identified 331 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92134 Environmental Temperature Problem Identified 651 Device performance was affected by the temperature, or changes in temperature, of the environment in which it was used. Device performance was affected by the temperature, or changes in temperature, of the environment in which it was used. C92051 Environment Problem Identified 331 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139515 Erroneous Data Transfer 4214 The device software fails to transfer the expected data within a system or to another device. The device software fails to transfer the expected data within a system or to another device. C92113 Software Problem Identified 104 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139517 Excessive Cooling Identified 4218 The device cooled the patient or another device more than intended or expected during operation. The device cooled the patient or another device more than intended or expected during operation. C92122 Thermal Problem 642 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139518 Excessive Heating Identified 4217 The device delivered more heat than intended or expected during operation. This applies to devices which are intended to deliver heat. Use "Overheating problem identified" for devices which are not intended to deliver heat during operation. The device delivered more heat than intended or expected during operation. This applies to devices which are intended to deliver heat. C92122 Thermal Problem 642 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139507 Fail-safe Problem Identified 4220 A system intended to prevent unsafe operation of the device did not operate correctly. A system intended to prevent unsafe operation of the device did not operate correctly. C92098 Protective System Problem Identified 3228 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92052 Failure to Calibrate 3250 A device that cannot calibrate (establish the relationship between a measuring device and the units of measure) to ensure accurate readings. A device that cannot calibrate (establish the relationship between a measuring device and the units of measure) to ensure accurate readings. C92088 Operational Problem Identified 114 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92053 Fatigue Problem 3251 Problems due to the weakening or breakdown of its material when subjected to stress or a series of repeated stresses. Problems due to the weakening or breakdown of its material when subjected to stress or a series of repeated stresses. C92120 Stress Problem Identified 3243 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92055 Fracture Problem 3252 Problems caused by the separation of a component, object, or material into two or more pieces including shear. Problems caused by the separation of a component, object, or material into two or more pieces including shear. C92120 Stress Problem Identified 3243 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92056 Friction Problem Identified 3253 Problems caused by its surface coming in contact with another surface or fluid. Problems caused by its surface coming in contact with another surface or fluid. C92079 Mechanical Problem Identified 180 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92057 Genotoxicity Problem Identified 3254 The device's ability to cause damage to genetic material (e.g. leading to malignant tumors). (See ISO 10993) The device's ability to cause damage to genetic material (e.g. leading to malignant tumors). C92030 Biological Problem Identified 3204 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92058 Gradient Induced Field Problem 323 Problems that result from the gradient-induced fields generated during radiologic procedures e.g. magnetic resonance imaging. Problems that result from the gradient-induced fields generated during radiologic procedures e.g. magnetic resonance imaging. C92102 Clinical Imaging Problem Identified 3230 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92059 Hardware Timing Problem Identified 211 Problems that results from improper sequential activation of components. Problems that results from improper sequential activation of components. C92045 Electrical Problem Identified 120 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92060 Hematological Problem Identified 3255 The device affects or impacts the blood or its components. (See ISO 10993 all parts) The device affects or impacts the blood or its components. (See ISO 10993 all parts) C92030 Biological Problem Identified 3204 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92062 Image Artifact 3256 The unacceptable distortion of an image due to signal loss that may occur during a radiologic procedure such as magnetic resonance imaging. The unacceptable distortion of an image due to signal loss that may occur during a radiologic procedure such as magnetic resonance imaging. C92102 Clinical Imaging Problem Identified 3230 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92063 Impedance Problem Identified 3257 Problems due to insufficient or excessive resistance to current flow either by the device or circuit. Problems due to insufficient or excessive resistance to current flow either by the device or circuit. C92045 Electrical Problem Identified 120 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92064 Improper Composition/ Concentration 3258 Problems associated with the improper combination of materials or elements present in the device (e.g. improper composition of the materials of a capacitor). 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 Inappropriate Material 202 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92133 Improper Physical Structure 3259 Problems related to the incorrect or inadequate arrangement of the parts, components, elements, or materials. Problems related to the incorrect or inadequate arrangement of the parts, components, elements, or materials. C92065 Inappropriate Material 202 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139519 Inadequate Cooling Identified 4219 The device did not sufficiently cool the patient or another device during operation. The device did not sufficiently cool the patient or another device during operation. C92122 Thermal Problem 642 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92135 Inadequate Immunity 3260 Problems related to immunity or capabilities to resist electromagnetic interference (EMI). Problems related to immunity or capabilities to resist electromagnetic interference (EMI). C92046 Electromagnetic Compatibility Problem Identified 197 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92137 Inadequate Labelling and/or Instructions for Use 154 Inadequate information on the labels or in the instructions for use e.g. steps that are difficult to follow or that are missing. Inadequate information on the labels or in the instructions for use e.g. steps that are difficult to follow or that are missing. C92071 Labeling and Instructions for Use/Maintenance 150 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139496 Inadequate or Incorrect Instructions for Maintenance 4208 Inadequate or incorrect information in the instructions for maintenance. Inadequate or incorrect information in the instructions for maintenance. C92071 Labeling and Instructions for Use/Maintenance 150 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139498 Inadequate Physicochemical Properties 4209 Problems that occur due to the physicochemical properties. Problems that occur due to the physicochemical properties. C92078 Material and/or Chemical Problem Identified 174 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92065 Inappropriate Material 202 Problems that occur due to the presence of a material that should not be present or part of the device. Problems that occur due to the presence of a material that should not be present or part of the device. C92078 Material and/or Chemical Problem Identified 174 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92066 Incompatible Component/ Accessory 102 A device that malfunctions due to a component(s)/accessory that does not operate correctly and according to the device's specifications. A device that malfunctions due to a component(s)/accessory that does not operate correctly and according to the device's specifications. C92070 Interoperability Problem Identified 3213 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92139 Incompatible Material 203 Problems that occur due to the incompatibility of materials that co-exist simultaneously as part of the device. Problems that occur due to the incompatibility of materials that co-exist simultaneously as part of the device. C92078 Material and/or Chemical Problem Identified 174 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92142 Incorrect Algorithm 618 The device software was found to implement an incorrect sequence of steps for a specific computation. The device software was found to implement an incorrect sequence of steps for a specific computation. C92042 Design Error 110 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92141 Incorrect Data Definition 3200 The device software was found to contain errors in specifying or manipulating data items. The device software was found to contain errors in specifying or manipulating data items. C92042 Design Error 110 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139499 Incorrect Dimension 4211 Problems caused by incorrect physical dimensions of the device or one of its parts Problems caused by incorrect physical dimensions of the device or one of its parts. C92079 Mechanical Problem Identified 180 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139501 Incorrect Interpretation of Results/Data 4232 Problems resulting from the incorrect interpretation by the user of the results or data provided by the device. Problems resulting from the incorrect interpretation by the user of the results or data provided by the device. C92088 Operational Problem Identified 114 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92136 Incorrect Labeling and/or Instructions for Use 156 Missing, incorrect, or inappropriate information on the labels e.g. mislabeled contents or device labeling characteristics or package contents. Missing, incorrect, or inappropriate information on the labels e.g. mislabeled contents or device labeling characteristics or package contents C92071 Labeling and Instructions for Use/Maintenance 150 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92067 Installation Problem Identified 3201 A device that malfunctions because it was incorrectly installed, set-up, or configured (e.g. misconfiguration of an "automatic" defibrillator to "semi-automatic", thereby leading to failure). A device that malfunctions because it was incorrectly installed, set-up, or configured (e.g. misconfiguration of an "automatic" defibrillator to "semi-automatic", thereby leading to failure). C92076 Manufacturing Process Problem Identified 170 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92068 Insulation Problem Identified 144 Problems due to inadequate or incorrect electrical insulation material. Problems due to inadequate or incorrect electrical insulation material. C92045 Electrical Problem Identified 120 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92069 Interface Design Error 113 The device software was found to contain errors in the user interface (including usability problems) or the interfaces with other systems. The device software was found to contain errors in the user interface (including usability problems) or the interfaces with other systems. C92042 Design Error 110 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92070 Interoperability Problem Identified 3213 Problems with the mechanical, electrical, or communication interface between two or more separate devices. Problems with the mechanical, electrical, or communication interface between two or more separate devices. C91801 FDA Manufacturer Evaluation Result Code Hierarchy FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139522 Known Interferent 4235 Known interferent in the sample identified. Known interferent in the sample identified. C139467 Patient Sample Problem 4233 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92071 Labeling and Instructions for Use/Maintenance 150 Insufficient, inadequate, or incorrect information provided on a device's label or documentation regarding e.g. its intended use, directions for use, and characteristics of the device, including its maintenance. Insufficient, inadequate, or incorrect information provided on a device's label or documentation regarding e.g. its intended use, directions for use, and characteristics of the device, including its maintenance. C91801 FDA Manufacturer Evaluation Result Code Hierarchy FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139500 Leakage/Seal 4210 Problems caused by inadequate/broken seal within the device. Problems caused by inadequate/broken seal within the device. C92079 Mechanical Problem Identified 180 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139502 Light Source Problem Identified 4212 Problems with the optical properties of a device such as diopter, glare, and irradiance or glistening. Problems with the optical properties of a device such as diopter, glare, and irradiance or glistening. C92089 Optical Problem Identified 3224 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92072 Loss of Power 610 A device that experienced problems due to a loss in the power supply. A device that experienced problems due to a loss in the power supply. C92097 Power Source Problem Identified 3227 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92073 Lubrication Problem Identified 145 Problems 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). Problems 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 Mechanical Problem Identified 180 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92074 Magnetically-Induced Movement 3215 Problems due to unintended or excessive movement created by the application of magnetic fields. Problems due to unintended or excessive movement created by the application of magnetic fields. C92102 Clinical Imaging Problem Identified 3230 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139497 Maintenance of Manufacturing Machinery 4242 Problems caused by failure to maintain manufacturing equipment used to produce the device. Problems caused by failure to maintain manufacturing equipment used to produce the device. C92076 Manufacturing Process Problem Identified 170 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92075 Maintenance Problem Identified 115 A device malfunction or problem that occurs after production because the device was not properly maintained according to the instructions (e.g. maintenance may be performed by user facility, distributor, or service provider). A device malfunction or problem that occurs after production because the device was not properly maintained according to the instructions (e.g. maintenance may be performed by user facility, distributor, or service provider). C91801 FDA Manufacturer Evaluation Result Code Hierarchy FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92076 Manufacturing Process Problem Identified 170 Problems with a device that can be traced to a problem in the manufacturing and/or production process. Problems with a device that can be traced to a problem in the manufacturing and/or production process. C91801 FDA Manufacturer Evaluation Result Code Hierarchy FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92078 Material and/or Chemical Problem Identified 174 Problems with the device materials or how its materials react to other elements either within the device or within the environment. Problems with the device materials or how its materials react to other elements either within the device or within the environment. C91801 FDA Manufacturer Evaluation Result Code Hierarchy FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92077 Material or Material Leachate Pyrogenic Problem 3216 The undesirable presence of pyrogens or fever-producing organisms caused by materials that permeate through the device. The undesirable presence of pyrogens or fever-producing organisms caused by materials that permeate through the device. C92030 Biological Problem Identified 3204 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92079 Mechanical Problem Identified 180 Problems that result from internal or external forces including fluids, other objects, or environmental or physiologic influences. Problems that result from internal or external forces including fluids, other objects, or environmental or physiologic influences. C91801 FDA Manufacturer Evaluation Result Code Hierarchy FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92080 Mechanical Shock Problem 3217 Problems caused by the sudden violent blow or collision to the whole device (e.g. by dropping). Problems caused by the sudden violent blow or collision to the whole device (e.g. by dropping). C92120 Stress Problem Identified 3243 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92081 Microbial Contamination 3218 The undesirable presence of microorganisms or microbes such as bacteria and fungi (yeasts and molds). The undesirable presence of microorganisms or microbes such as bacteria and fungi (yeasts and molds). C92054 Biological Contamination 142 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139508 Missing or Inadequate Safety Measures 4227 Safety measures are inadequately applied or missing. Safety measures are inadequately applied or missing. C92098 Protective System Problem Identified 3228 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92121 Molecular Structure Problem 3219 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). 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 Inappropriate Material 202 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92082 Mutagenic Problem 3220 The device's ability to change genetic information (usually DNA) of an organism and thus increasing the frequency of mutations. The device's ability to change genetic information (usually DNA) of an organism and thus increasing the frequency of mutations. C92057 Genotoxicity Problem Identified 3254 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139488 Network Communication Problem 4205 Communications problems between devices within a network system. Communications problems between devices within a network system. C92034 Communications Problem Identified 628 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139523 New or Unknown Interferent 4234 New or unknown endogenous or exogenous interferent (sample) identified. New or unknown endogenous or exogenous interferent (sample) identified. C139467 Patient Sample Problem 4233 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92083 No Device Problem Found 213 The device either functioned as intended or a problem was not found. The device either functioned as intended or a problem was not found. C91801 FDA Manufacturer Evaluation Result Code Hierarchy FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92084 No Findings Available 3221 Use when no investigation can be performed and therefore no results will be obtained. Use when no investigation can be performed and therefore no results will be obtained. C91801 FDA Manufacturer Evaluation Result Code Hierarchy FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92085 Non-Functional Defect 3222 The device software contained software errors that did not impact its operation. The device software contained software errors that did not impact its operation. C92042 Design Error 110 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92087 Open Circuit 122 Problem due to an electrical circuit that does not conduct current because a switch is open, a wire is broken, etc. Problem due to an electrical circuit that does not conduct current because a switch is open, a wire is broken, etc. C92045 Electrical Problem Identified 120 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92088 Operational Problem Identified 114 Problems that occur during the performance, use, or functioning of the device. Problems that occur during the performance, use, or functioning of the device. C91801 FDA Manufacturer Evaluation Result Code Hierarchy FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92089 Optical Problem Identified 3224 C91801 FDA Manufacturer Evaluation Result Code Hierarchy FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92090 Optical Transmission Problem Identified 196 Problems with the device's ability to pass light energy. Problems with the device's ability to pass light energy. C92089 Optical Problem Identified 3224 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139520 Overheating Problem Identified 4216 The device was found to become hotter than expected during operation. This applies to devices which are not intended to deliver heat. Use "Excessive heating identified" for devices which are intended to deliver heat during operation. Use "Inadequate cooling identified" if the overheating was related to a problem with a cooling system. The device was found to become hotter than expected during operation. This applies to devices which are not intended to deliver heat. C92122 Thermal Problem 642 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92093 Packaging Compromised 171 Problems that occurred because of a compromised packaging of the device (e.g. broken or incomplete seal). Problems that occurred because of a compromised packaging of the device (e.g. broken or incomplete seal). C92094 Packaging Problem Identified 111 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139503 Packaging Contains Incorrect Device 4245 Problems that occurred because the packaging contained an incorrect device. Problems that occurred because the packaging contained an incorrect device. C92094 Packaging Problem Identified 111 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139504 Packaging Contains Unintended Material 4244 Problems that occurred because unintended material was packaged with the device. Problems that occurred because unintended material was packaged with the device. C92094 Packaging Problem Identified 111 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139505 Packaging Materials Problem 4243 Problems that occurred because of the composition or type of packaging materials was inappropriate for the device. Problems that occurred because of the composition or type of packaging materials was inappropriate for the device. C92094 Packaging Problem Identified 111 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92094 Packaging Problem Identified 111 Problems that occurred because of the device packaging. Problems that occurred because of the device packaging. C92076 Manufacturing Process Problem Identified 170 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139467 Patient Sample Problem 4233 Problems that occurred due to endogenous or exogenous interferent in the sample, or unexpected variation in the target analyte/marker. Problems that occurred due to endogenous or exogenous interferent in the sample, or unexpected variation in the target analyte/marker. C91801 FDA Manufacturer Evaluation Result Code Hierarchy FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92095 Platelet Activation Problem 3226 The device affects the body's ability to activate platelet formation. The device affects the body's ability to activate platelet formation. C92060 Hematological Problem Identified 3255 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92096 Power Fluctuation 659 The device failed due to fluctuations within the power supply (e.g. transient power, power spike, power dip, or power sequencing). The device failed due to fluctuations within the power supply (e.g. transient power, power spike, power dip, or power sequencing). C92097 Power Source Problem Identified 3227 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92097 Power Source Problem Identified 3227 Problems related to the source that provides electrical power to the device. Problems related to the source that provides electrical power to the device. C92045 Electrical Problem Identified 120 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139524 Pre-analytical Handling Problem 4237 Incorrect pre-analytical handling of patient's sample by the user. Incorrect pre-analytical handling of patient's sample by the user. C139467 Patient Sample Problem 4233 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139509 Premature Indicator Activation 4224 A system intended to indicate the device status was triggered prematurely. A system intended to indicate the device status was triggered prematurely. C92098 Protective System Problem Identified 3228 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92123 Problem due to Thrombosis Activation 3244 The device causes the formation of blood clots in or along blood vessels resulting in disturbed or disrupted blood flow. The device causes the formation of blood clots in or along blood vessels resulting in disturbed or disrupted blood flow. C92060 Hematological Problem Identified 3255 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139510 Problem of Device to Self-Test 4222 Malfunction of the device's self-test system. Malfunction of the device's self-test system. C92098 Protective System Problem Identified 3228 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139511 Problem to Auto Stop 4223 An auto stop function of a device did not operate correctly. An auto stop function of a device did not operate correctly. C92098 Protective System Problem Identified 3228 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92098 Protective System Problem Identified 3228 Problems related to the system(s) designed to prevent or warn about unsafe operation of the device. Problems related to the system(s) designed to prevent or warn about unsafe operation of the device. C91801 FDA Manufacturer Evaluation Result Code Hierarchy FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92100 Radiofrequency Induced Overheating 3229 Problems due to unintended radiofrequency-induced temperature increase that can occur in the vicinity of the device. Problems due to unintended radiofrequency-induced temperature increase that can occur in the vicinity of the device. C92102 Clinical Imaging Problem Identified 3230 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92101 Radiofrequency Interference (RFI) 611 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. 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 Electromagnetic Compatibility Problem Identified 197 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92103 Reactivity Problem Identified 3231 Problems that occur due to the reactivity of materials (e.g. over-react or under-react). Problems that occur due to the reactivity of materials (e.g. over-react or under-react). C92078 Material and/or Chemical Problem Identified 174 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92104 Reproductive Toxicity Problem Identified 3232 The device affects reproductive function, embryo development (teratogenicity), and prenatal and early postnatal development. (ISO 10993 part 3) The device affects reproductive function, embryo development (teratogenicity), and prenatal and early postnatal development. (ISO 10993 part 3) C92030 Biological Problem Identified 3204 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139512 Reset Problem 4225 The device does not reset properly. The device does not reset properly. C92098 Protective System Problem Identified 3228 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92143 Results Pending Completion of Investigation 3233 Investigation is ongoing and results are not yet available. Do not use this code if the investigation is complete. Investigation is ongoing and results are not yet available. Do not use this code if the investigation is complete. C91801 FDA Manufacturer Evaluation Result Code Hierarchy FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139513 Shielding Problem 4226 Inadequate shielding of/by the device. Inadequate shielding of/by the device. C92098 Protective System Problem Identified 3228 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92108 Short Circuit 121 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. 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 Electrical Problem Identified 120 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92109 Signal Loss 3237 Problems due to the loss or weakening of an electrical signal or signals. Problems due to the loss or weakening of an electrical signal or signals. C92045 Electrical Problem Identified 120 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92111 Software Installation Problem Identified 3238 The device software was not installed as per the specifications or failed to properly install. The device software was not installed as per the specifications or failed to properly install. C92113 Software Problem Identified 104 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139516 Software Maintenance Problem Identified 4213 The device software was not maintained/updated properly. The device software was not maintained/updated properly. C92113 Software Problem Identified 104 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92113 Software Problem Identified 104 C91801 FDA Manufacturer Evaluation Result Code Hierarchy FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92114 Software Requirement Error 3239 The software requirements for the device are either incomplete, inadequate, or in conflict. The software requirements for the device are either incomplete, inadequate, or in conflict. C92113 Software Problem Identified 104 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92115 Software Runtime Error 3240 The device software failed during operation as a result of a coding error. The device software failed during operation as a result of a coding error. C92113 Software Problem Identified 104 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92116 Software Security Vulnerability 3241 The device software failed to provide adequate authorization, access control, protection and accountability features. The device software failed to provide adequate authorization, access control, protection and accountability features. C92113 Software Problem Identified 104 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92117 Software Timing Problem 634 Problems that results from the incorrect sequencing or activation of software modules. Problems that results from the incorrect sequencing or activation of software modules. C92042 Design Error 110 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139576 Sterilization Problem Identified 4241 Problems that occurred during terminal sterilization by the manufacturer. Problems that occurred during terminal sterilization by the manufacturer. C92076 Manufacturing Process Problem Identified 170 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92118 Stiffness Problem Identified 3242 Problems that occurred when its material is either too flexible/pliable or inflexible/rigid when in contact by an applied force. Problems that occurred when its material is either too flexible/pliable or inflexible/rigid when in contact by an applied force. C92079 Mechanical Problem Identified 180 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92119 Storage Problem Identified 193 Problems that result from storing the device in an uncontrolled or improper environment (e.g. moisture sensitive devices stored in a humid environment). Problems that result from storing the device in an uncontrolled or improper environment (e.g. moisture sensitive devices stored in a humid environment). C139468 Transport/Storage Problem Identified 4246 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92120 Stress Problem Identified 3243 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. 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 Mechanical Problem Identified 180 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92122 Thermal Problem 642 Problems related to the temperature of the device. Note: For problems related to environmental temperature use ''Environment Problem Identified''. Problems related to the temperature of the device. C91801 FDA Manufacturer Evaluation Result Code Hierarchy FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92124 Tolerance Stack-Up 176 Problems that result from a combination of specification variances of the components. Problems that result from a combination of specification variances of the components. C92078 Material and/or Chemical Problem Identified 174 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92107 Transport Problem Identified 3236 Problems traced to how the device was transported e.g. temperature of shipping compartment or method of transportation. Problems traced to how the device was transported e.g. temperature of shipping compartment or method of transportation. C139468 Transport/Storage Problem Identified 4246 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139468 Transport/Storage Problem Identified 4246 Problems was caused by transport or storage conditions. Problems was caused by transport or storage conditions. C91801 FDA Manufacturer Evaluation Result Code Hierarchy FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139495 Unintended Compatibility 4207 The device was confirmed to be compatible with another device with which the device is intended to be incompatible. The device was confirmed to be compatible with another device with which the device is intended to be incompatible. C92070 Interoperability Problem Identified 3213 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139490 Unintended Emission 4204 Problems due to unintended emission of electromagnetic energy by the device. Problems due to unintended emission of electromagnetic energy by the device. C92046 Electromagnetic Compatibility Problem Identified 197 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C139484 Unintended Presence of Allergens 4202 Unintended or unexpected presence of allergens in the device. If the presence of the allergen is expected but not adequately labelled, then use "Labelling Problem". Unintended or unexpected presence of allergens in the device. C92030 Biological Problem Identified 3204 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92129 Vibration Problem 649 Problems caused by the constant rhythmic motion of the device, or something in the environment to which the device is exposed. Problems that result from a combination of specification variances of the components. C92120 Stress Problem Identified 3243 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92130 Wear Problem 140 Problems due to the premature or expected erosion of its material by use, deterioration, or change. Problems due to the premature or expected erosion of its material by use, deterioration, or change. C92120 Stress Problem Identified 3243 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92131 Wired Communication Problem 608 Communications problems between devices within a wired system. Communications problems between devices within a wired system. C92034 Communications Problem Identified 628 FDA C91801 FDA Manufacturer Evaluation Result Code Hierarchy C92132 Wireless Communication Problem 3248 Communications problems between devices within a wireless system. Communications problems between devices within a wireless system. C92034 Communications Problem Identified 628 FDA C54450 FDA Patient Problem Code Hierarchy C34331 Abdominal Cramps 2543 Cramps, Abdominal An involuntary muscular contraction involving a muscle of the abdomen or of a hollow organ within the abdomen. C34827 Cramp(s) 2193 FDA C54450 FDA Patient Problem Code Hierarchy C35221 Abortion 1688 The unintentional or intentional loss of a pregnancy before 22 weeks gestation. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50500 Abortion, Complete 2212 All products of conception are expelled and identified. Expulsion of all the products of conception following spontaneous, medical or operative pregnancy termination. C35221 Abortion 1688 FDA C54450 FDA Patient Problem Code Hierarchy C50608 Abortion, Incomplete 2213 The uterus is not entirely emptied of its contents. The uterus is not entirely emptied of products of conception following spontaneous, medical or operative pregnancy termination. C35221 Abortion 1688 FDA C54450 FDA Patient Problem Code Hierarchy C50613 Abortion, Induced 2214 Abortion, Artificial|Artificial Abortion|Induced Abortion Abortion brought on intentionally. Abortion brought on intentionally. C35221 Abortion 1688 FDA C54450 FDA Patient Problem Code Hierarchy C50652 Abortion, Missed 2215 Retention in uterus of an abortus that has been dead at least 4 weeks. Retention in uterus of an abortus. C35221 Abortion 1688 FDA C54450 FDA Patient Problem Code Hierarchy C50449 Abrasion 1689 Abraded wound; excoriation or circumscribed removal of the superficial layers of the skin or mucous membrane. Superficial damage to the skin caused by rubbing or scraping. C3671 Injury 2348 FDA C54450 FDA Patient Problem Code Hierarchy C26686 Abscess 1690 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 Infection, Bacterial 1735 FDA C54450 FDA Patient Problem Code Hierarchy C50451 Achalasia 1692 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50453 Acoustic Trauma 1694 Injury to the hearing mechanisms within the inner ear, caused by excessively loud noise. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C54685 Adhesion(s) 1695 A fibrous band of tissue that connects normally separate body regions. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3353 Adult Respiratory Distress Syndrome 1696 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C2851 AIDS, Acquired Immunodeficiency Syndrome 1684 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 lymphoma and Kaposi sarcoma). The human immunodeficiency virus is transmitted through sexual contact, sharing of contaminated needles, or transfusion of contaminated blood. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50455 Air Embolism 1697 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 air in the vascular system; occurrence is related to the entry of air into the venous circulation following trauma or surgery. C26759 Embolism 1829 FDA C54450 FDA Patient Problem Code Hierarchy C50456 Airway Obstruction 1699 Blockage of air flow in the respiratory tract. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C7941 Alteration In Body Temperature 2682 C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50458 Ambulation Difficulties 2544 Difficulties, Ambulation Any persistent problem with walking. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50459 Amnionitis 2217 Inflammation of the amnion. Inflammation of the amnion. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50410 Anaphylactoid 2218 Resembling anaphylaxis. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3720 Anaplastic Large Cell Lymphoma 3264 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 Lymphoma 3263 FDA C54450 FDA Patient Problem Code Hierarchy C50417 Anastomose, Failure To 1028 Failure of a surgically-induced connection between tubular structures in the body. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C2869 Anemia 1706 A reduction in the number of red blood cells, the amount of hemoglobin, and/or the volume of packed red blood cells. 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C51220 Anesthesia, Insufficient, Light Or Patchy 1707 Insufficient, Light Or Patchy Anesthesia|Light, Patchy Or Insufficient Anesthesia|Patchy, Light Or Insufficient Anesthesia A state of consciousness that permits the formation of explicit and implicit memories while under general anesthesia. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26693 Aneurysm 1708 Bulging or ballooning in an area of an artery secondary to arterial wall weakening. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C51221 Angina 1710 Paroxysms of chest pain due to reduced oxygen to the heart. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C2876 Anoxia 1711 Absence or reduction of oxygen in body tissue. C3890 Hypoxia 1918 FDA C54450 FDA Patient Problem Code Hierarchy C51222 Antibiotics, Reaction To 1713 C25637 Reaction 2414 FDA C54450 FDA Patient Problem Code Hierarchy C26696 Anxiety 2328 Apprehension of danger and dread accompanied by restlessness, tension, tachycardia, and dyspnea unattached to a clearly identifiable stimulus. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50461 Aortic Dissection 2491 Dissection, Aortic A progressive tear in the tissue lining the aorta, characterized by the passage of blood from the tunica intima into, and partially through, the tunica media. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C51223 Aortic Insufficiency 1715 Dysfunction of the aortic valve characterized by incomplete valve closure. C50796 Insufficiency, Valvular 1926 FDA C54450 FDA Patient Problem Code Hierarchy C50861 Aortic Regurgitation 1716 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 Aortic Insufficiency 1715 FDA C54450 FDA Patient Problem Code Hierarchy C50462 Aortic Stenosis 1717 Narrowing of the orifice of the aortic valve or of the supravalvular or subvalvular regions. Narrowing of the orifice of the aortic valve. C62433 Valvular Stenosis 2697 FDA C54450 FDA Patient Problem Code Hierarchy C50416 Apgar Score, Decreased Or Low 1718 Decreased Or Low Apgar Score|Low Or Decreased Apgar Score|Score, Decreased Or Low Apgar An Apgar score less than seven. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C15191 Apheresis 1719 A procedure that collects a component of the peripheral blood while returning the rest to the donor. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50824 Apicectomy 2372 Excision of the apex of the petrous portion of the temporal bone. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26698 Apnea 1720 Arrest, Respiratory|Respiratory Arrest Cessation of breathing. Transient cessation of respiration. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C64343 Appropriate Term/Code Not Available 3191 IMDRF:A27 The device problem is not adequately described by any other term. Note: this code must not be used unless there is no other feasible code. The preferred term should be documented when submitting an adverse event report. This information will be used to determine if a new term should be added to the code table. A device problem is not adequately described by any other term. Note: this code must not be used unless there is no other feasible code. C54451 FDA Device Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50749 Arachnoiditis, Spinal 2390 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C2881 Arrhythmia 1721 Any variation from the normal rate or rhythm (which may include the origin of the impulse and/or its subsequent propagation) in the heart. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C34398 Arteriosclerosis 1722 A vascular disorder characterized by thickening and hardening of the walls of the arteries. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50464 Arthralgia 2355 Joint Pain|Pain, Joint Pain in a joint. Pain in a joint. C3303 Pain 1994 FDA C54450 FDA Patient Problem Code Hierarchy C2883 Arthritis 1723 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 Joint Disorder 2373 FDA C54450 FDA Patient Problem Code Hierarchy C2884 Arthritis, Rheumatoid 1724 Rheumatoid Arthritis A chronic, systemic autoimmune disorder characterized by inflammation in the synovial membranes and articular surfaces. It manifests primarily as a symmetric, erosive polyarthritis that spares the axial skeleton and is typically associated with the presence in the serum of rheumatoid factor. C2883 Arthritis 1723 FDA C54450 FDA Patient Problem Code Hierarchy C2885 Ascites 2596 The accumulation of fluid in the peritoneal cavity, which may be serous, hemorrhagic, or the result of tumor metastasis to the peritoneum. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50465 Asphyxia 1851 A condition due to lack of oxygen in respired air, resulting in impending or actual cessation of life. A state of general hypoxia and hypercapnea, resulting in acidosis, which affects all tissues in the body. C3890 Hypoxia 1918 FDA C54450 FDA Patient Problem Code Hierarchy C28245 Aspiration 1725 A disorder characterized by inhalation of solids or liquids into the lungs. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C28397 Asthma 1726 A chronic respiratory disease manifested as difficulty breathing due to the narrowing of bronchial passageways. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C35768 Atherosclerosis 1728 Build-up of fatty material and calcium deposition in the arterial wall resulting in partial or complete occlusion of the arterial lumen. C34398 Arteriosclerosis 1722 FDA C54450 FDA Patient Problem Code Hierarchy C50466 Atrial Fibrillation 1729 An arrhythmia in which minute areas of the atrial myocardium are in various uncoordinated stages of depolarization and repolarization; instead of intermittently contracting, the atria quiver continuously in a chaotic pattern, causing a totally irregular, often rapid ventricular rate. A disorder characterized by 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 irregular ventricular response. (CDISC) C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C51224 Atrial Flutter 1730 A disorder characterized by 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) C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50467 Atrial Perforation 2511 A rupture in atrial tissue due to traumatic or pathologic processes. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C35481 Atrial Tachycardia 1731 A disorder characterized by 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) C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C2889 Autoimmune Disease 1732 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). C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C16313 Autoimmune Reaction 1733 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C51225 Biliary Cirrhosis 1736 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). C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50551 Blinking, Excessive 2229 Excessive Blinking C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50447 Blood Gas Measurements, Abnormal 1034 Abnormal Blood Gas Measurements|Measurements, Abnormal Blood Gas C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50470 Blood Loss 2597 Loss Of Blood Loss of blood from the circulation, either internally or externally. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C27123 Blurred Vision 2137 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) C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C39611 Bowel Perforation 2668 A rupture in the wall of the small or large intestine due to traumatic or pathologic processes. C4080 Perforation 2001 FDA C54450 FDA Patient Problem Code Hierarchy C37920 Bradycardia 1751 Decreased Heart Rate|Heart Rate, Decreased An abnormally slow heart rate. Thresholds for different age, gender, and patient populations exist. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50440 Brain Injury 2219 Brain Damage|Injury, Brain Trauma to the brain. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3197 Breast Lumps 2439 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C2910 Breast Neoplasm 2438 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C2911 Bronchitis 1752 An acute or chronic inflammatory process affecting the bronchi. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26710 Bronchopneumonia 2437 Acute inflammation of the walls of the terminal bronchioles that spreads into the peribronchial alveoli and alveolar ducts. It results in the creation of foci of consolidation, which are surrounded by normal parenchyma. It affects one or more lobes, and is frequently bilateral and basal. It is usually caused by bacteria (e.g., Staphylococcus, Streptococcus, Haemophilus influenzae). Signs and symptoms include fever, cough with production of brown-red sputum, dyspnea, and chest pain. C3333 Pneumonia 2011 FDA C54450 FDA Patient Problem Code Hierarchy C34439 Bronchospasm 2598 Sudden contraction of the smooth muscles of the bronchial wall. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C37921 Bruise 1754 Injury of the soft tissues or bone without breaking the skin that is characterized by blood leakage into the surrounding area. C3671 Injury 2348 FDA C54450 FDA Patient Problem Code Hierarchy C34441 Burn(s) 1757 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 Injury 2348 FDA C54450 FDA Patient Problem Code Hierarchy C50473 Burn, Bowel 1756 Bowel Burn C34441 Burn(s) 1757 FDA C54450 FDA Patient Problem Code Hierarchy C50506 Burn, Corneal 2523 Corneal Burn Chemical or radiant injury to the cornea. C34441 Burn(s) 1757 FDA C54450 FDA Patient Problem Code Hierarchy C50768 Burn, Thermal 2530 Burns, Thermal|Thermal Burn A burn injury caused by heat or fire. C34441 Burn(s) 1757 FDA C54450 FDA Patient Problem Code Hierarchy C50476 Burning Sensation 2146 Sensation, Burning A sensation of stinging or heat, not necessarily accompanied by redness or physical signs of irritation. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3672 Calcification 1758 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 Deposits 1809 FDA C54450 FDA Patient Problem Code Hierarchy C9305 Cancer 3262 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C4872 Cancer, Breast 1759 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 Cancer 3262 FDA C54450 FDA Patient Problem Code Hierarchy C50702 Capsular Bag Tear, Posterior 2639 C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50478 Capsular Contracture 1761 The tightening of scar tissue that forms around the implant. The tightening of scar tissue that forms around the implant. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50479 Cardiac Arrest 1762 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C73502 Cardiac Perforation 2513 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) C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50481 Cardiac Tamponade 2226 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C34830 Cardiomyopathy 1764 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50483 Cardiopulmonary Arrest 1765 Arrest, Cardiopulmonary Cessation of breathing and/or cardiac function. Cessation of breathing and/or cardiac function. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26713 Cataract 1766 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.) C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50614 Cataract, Induced 1767 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 Cataract 1766 FDA C54450 FDA Patient Problem Code Hierarchy C34442 Caustic/Chemical Burns 2549 Burn, Caustic/Chemical|Chemical/Caustic Burn A burn caused by exposure to chemical substances. C34441 Burn(s) 1757 FDA C54450 FDA Patient Problem Code Hierarchy C26715 Cellulitis 1768 Inflammation of the dermis and subcutaneous tissues caused by a bacterial infection. Symptoms include erythema, edema, and pain to the affected area. C2890 Infection, Bacterial 1735 FDA C54450 FDA Patient Problem Code Hierarchy C50484 Cephalohematoma 2599 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50803 Cerebral Ventriculomeglia 2133 Ventriculomeglia Abnormal enlargement of the cerebral ventricles. C50448 Ventricle, Abnormality Of 2078 FDA C54450 FDA Patient Problem Code Hierarchy C50487 Cerebrospinal Fluid Leakage 1772 Fluid, Leakage Of Cerebrospinal|Leakage Of Cerebrospinal Fluid The loss of cerebrospinal fluid into the surrounding tissues. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3390 Cerebrovascular Accident 1770 CVA, Cerebrovascular Accident|Cerebrovascular Accident, (CVA)|Stroke|Stroke Syndrome|Syndrome, Stroke A sudden loss of neurological function secondary to hemorrhage or ischemia in the brain parenchyma due to a vascular event. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50488 Cervical Changes 1773 Cervical Change|Changes, Cervical Changes such as abnormal, pathological, benign, malignant, etc. An alteration in the cervix. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C36290 Chemical Exposure 2570 Exposure, Chemical Contact with a chemical substance through touch, inhalation, or ingestion. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50490 Chemosis 1775 Excessive edema of the ocular conjunctiva. Edema of the mucous membrane of the eyeball and eyelid lining. C3002 Edema 1820 FDA C54450 FDA Patient Problem Code Hierarchy C38665 Chest Pain 1776 Pain In Chest Pain in the chest. C3303 Pain 1994 FDA C54450 FDA Patient Problem Code Hierarchy C50491 Chest Tightness/Pressure 2463 Pressure/Tightness In Chest|Tightness/Pressure In Chest C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C35143 Chills 2191 Shivering or moderate tremors of the body often accompanied by a cold sensation. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50494 Choking 2464 Interference with respiration by compression or obstruction of the larynx or trachea. C3671 Injury 2348 FDA C54450 FDA Patient Problem Code Hierarchy C26720 Chorioamnionitis 1777 A morphologic finding indicating inflammation of the fetal sac membranes. It is characterized by neutrophilic infiltration of the amnion and chorion. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3199 Chronic Obstructive Pulmonary Disease, (COPD) 2237 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50495 Claudication 2550 Limping or lameness. Pain, cramping, and fatigue of the lower extremities upon ambulation due to ischemia. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50834 Closed Capsulotomy 2626 A procedure used to treat capsular contraction that uses physical manipulation of the breast to manually rupture scar tissue and release pressure on an implant. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C34455 Clouding, Central Corneal 2228 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. Clouding of the middle area of the cornea, usually as a result of scarring due to Infection, injury, or inflammation. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C2902 Coagulopathy 1779 A condition in which there is a deviation from or interruption of the normal coagulation properties of the blood. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50457 Cognitive Changes 2551 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. 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50497 Collapse 2416 Failure of a physiologic function or system. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C34497 Coma 2417 Comatose A state of profound unconsciousness associated with markedly depressed cerebral activity. Causes include central nervous system damage, intoxication, and metabolic abnormalities. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50499 Complaint, Ill-Defined 2331 Ill-Defined Complaint C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50501 Complete Heart Block 2627 A disorder characterized by 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) C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50502 Concussion 2192 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 Injury 2348 FDA C54450 FDA Patient Problem Code Hierarchy C37928 Confusion/Disorientation 2553 Disorientation/Confusion A mental state characterized by a lack of clear and orderly thought and behavior. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C2849 Congenital Defect/Deformity 1782 Defect/Deformity, Congenital|Deformity/Defect, Congenital Any abnormality, anatomical or biochemical, evident at birth or during the neonatal period. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3080 Congestive Heart Failure 1783 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C34504 Conjunctivitis 1784 Inflammation of the conjunctiva of the eye. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26729 Connective Tissue Disease 1786 Disease, Connective Tissue|Tissue Disease, Connective A non-neoplastic or neoplastic disorder that affects the connective tissue. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C37930 Constipation 3274 Irregular and infrequent or difficult evacuation of the bowels. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50441 Contusion 1787 A bruise; an injury of a part without a break in the skin. A bruise due to trauma. C3671 Injury 2348 FDA C54450 FDA Patient Problem Code Hierarchy C50496 Convulsion, Clonic 2222 Clonic Convulsion A convulsion marked by alternating contracting and relaxing of the muscles. A convulsion marked by alternating contracting and relaxing of the muscles. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50776 Convulsion, Tonic 2223 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50692 Cornea, Perforation Of 1792 Perforation Of Cornea A rupture in the corneal tissue due to traumatic or pathologic processes C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26730 Corneal Abrasion 1789 Injury to the epithelium of the cornea. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50507 Corneal Decompensation 1790 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50508 Corneal Edema 1791 Edema, Corneal Hazy, swollen cornea. Hazy, swollen cornea. C3002 Edema 1820 FDA C54450 FDA Patient Problem Code Hierarchy C50509 Corneal Haze 1878 Opacity within the cornea. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50510 Corneal Infiltrates 2231 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50511 Corneal Scar 1793 Scar, Corneal Replacement of corneal tissue with scar tissue as a result of injury to the deeper layers of the cornea. C34483 Scarring 2061 FDA C54450 FDA Patient Problem Code Hierarchy C50513 Corneal Touch 1794 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50515 Corneal Ulcer 1796 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C34827 Cramp(s) 2193 A sustained, sudden and involuntary contraction of a muscle or group of muscles. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50505 Cross-Patient Exposure To Body Fluids 1745 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C35375 Crushing Injury 1797 Injury, Crushing Traumatic compression of the body or a part of the body. C3671 Injury 2348 FDA C54450 FDA Patient Problem Code Hierarchy C50517 Cusp Tear 2656 A split located on a leaflet of a heart valve that prevents its complete closing, which can result in valvular dysfunction. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26737 Cyanosis 1798 A bluish or purplish discoloration of the skin and mucous membranes resulting from a reduced concentration of oxygenated hemoglobin in the blood. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50519 Cyclitis 1799 Inflammation of the ciliary body. Inflammation of the ciliary body. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50520 Cyst(s), Formation Of 1800 Formation Of Cyst(s) A morphologic finding indicating the presence of cystic structures in a tissue sample. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50521 Cytomegaloviral Retinitis 1957 Retinitis, Cytomegaloviral Inflammation of the retina due to cytomegalovirus. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C14196 Cytomegalovirus (CMV) 2220 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C27644 Deafness 1801 An inherited or acquired condition characterized by the inability to hear in one or both ears. C35731 Hearing Loss 1882 FDA C54450 FDA Patient Problem Code Hierarchy C28554 Death 1802 Expired/Death The cessation of life. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50620 Death, Intrauterine Fetal 1855 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 of a fetus after 10 weeks gestation. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50472 Debris, Bone Shedding 1803 Bone Shedding Debris|Shedding Of Bone Debris Shedding of accumulated bone fragments. Shedding of accumulated bone fragments. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50923 Decreased Apgar 1805 C50416 Apgar Score, Decreased Or Low 1718 FDA C54450 FDA Patient Problem Code Hierarchy C73504 Decreased Sensitivity 2683 C25637 Reaction 2414 FDA C54450 FDA Patient Problem Code Hierarchy C50527 Dehiscence Of Organ 2502 A splitting open of an anatomical structure, zone, or organ with the exposure or discharge of its content. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26740 Dehydrated 1807 A condition resulting from the excessive loss of water from the body. It is usually caused by severe diarrhea, vomiting or diaphoresis. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C4786 Dementia 1808 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50531 Dementia, Dialysis 2224 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 Encephalopathy 1833 FDA C54450 FDA Patient Problem Code Hierarchy C9442 Deposits 1809 Accumulation of extraneous inorganic matter in tissues or cavities. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C2982 Depression 2361 A melancholy feeling of sadness and despair. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26744 Dermatomyositis 2253 Inflammation of the skin and muscle. C2889 Autoimmune Disease 1732 FDA C54450 FDA Patient Problem Code Hierarchy C26874 Detached Retina 2047 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C62946 Device Fragments In Patient 3165 Issue associated with the inability to retrieve device and/or device fragments during medical procedures. Issue associated with the inability to retrieve device and/or device fragments during medical procedures. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50530 Diabetic Ketoacidosis 2364 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50403 Diaphoretic 2452 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C2987 Diarrhea 1811 Watery bowel movements. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50492 Difficulty Chewing 2670 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C21007 Disability 2371 Any physical or mental impairment that interferes with an individual's ability to perform desired activities. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50707 Disc Impingement 2655 C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50437 Discharge 2225 The leakage of a substance from an orifice or wound. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50535 Discomfort 2330 A feeling of mental or physical uneasiness, pain, or distress. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50536 Disfigurement 2360 Permanent deformation of appearance. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C61409 Dissection 3160 C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C2992 Disseminated Intravascular Coagulation (DIC) 1813 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 Coagulopathy 1779 FDA C54450 FDA Patient Problem Code Hierarchy C50537 Distention 2601 The condition of being stretched beyond normal dimensions. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C37942 Distress 2329 A state of physiological or psychological stress that cannot be compensated for by normal adaptive measures. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C37943 Dizziness 2194 A sensation of lightheadedness, unsteadiness, turning, spinning or rocking. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C34553 Dry Eye(s) 1814 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50539 Dyskinesia 2363 Difficulty moving; distortion or impairment of voluntary movement, as in tic, spasm, or myoclonus. Abnormality or impairment of voluntary movement. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C2980 Dysphagia 1815 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C35546 Dysphasia 2195 Impairment of verbal communication skills, often resulting from brain damage. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C2998 Dyspnea 1816 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C2999 Dysuria 2684 Difficulty or pain in urination. Pain or discomfort during urination. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26758 Ecchymosis 1818 A flat discoloration of the skin or a mucous membrane, larger in area than a petechia, caused by the extravasation of blood. C26791 Hemorrhage 1888 FDA C54450 FDA Patient Problem Code Hierarchy C3002 Edema 1820 Accumulation of an excessive amount of fluid in cells or intercellular tissues. C3399 Swelling 2091 FDA C54450 FDA Patient Problem Code Hierarchy C35468 Edema, Macular 1822 Macular Edema Accumulation of intraretinal fluid and protein in the macula, which may result in swelling and decreased central vision. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50901 Edema, Microcystic 1823 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 Corneal Edema 1791 FDA C54450 FDA Patient Problem Code Hierarchy C50859 Edema, Stromal 1824 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 Corneal Edema 1791 FDA C54450 FDA Patient Problem Code Hierarchy C50543 EKG/ECG Changes 1817 Changes In EKG/ECG|ECG/EKG Changes Changes in cardiac electrical activity. An electrocardiographic finding of a change in cardiac electrical activity. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50541 Electric Shock 2554 Electrical Shock|Shock, Electric|Shock, Electrical A brief, unintentional exposure to an electric current, which may result in local tissue damage due to thermal injury or in a cardiac dysrhythmia. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50544 Electrocution 1827 The passage of electrical current through the body. The passage of electrical current through the body. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50545 Electrolyte Imbalance 2196 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50542 Electro-Mechanical Dissociation 1826 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26759 Embolism 1829 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50547 Embolus 1830 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50489 Emotional Changes 1831 Changes, Emotional C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3348 Emphysema, Pulmonary 1832 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 Chronic Obstructive Pulmonary Disease, (COPD) 2237 FDA C54450 FDA Patient Problem Code Hierarchy C26760 Encephalitis 2429 An inflammatory process affecting the brain parenchyma. Causes include viral infections and less frequently bacterial infections, toxins, and immune-mediated processes. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26920 Encephalopathy 1833 A functional and/or structural disorder of the brain caused by diseases (e.g. liver disease, kidney disease), medications, chemicals, and injuries. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C34582 Endocarditis 1834 Inflammation of the endocardium. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C34586 Endophthalmitis 1835 An infectious process affecting the internal structures of the eye. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50480 Enzyme Elevation, Cardiac 1838 Cardiac Enzyme Elevation|Elevation Of Cardiac Enzymes C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50443 Erosion 1750 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 Tissue Breakdown 2681 FDA C54450 FDA Patient Problem Code Hierarchy C50550 Eructate 1839 To belch, the casting of upwind from the stomach. To belch, the casting of upwind from the stomach. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26901 Erythema 1840 Red discoloration of the skin caused by infectious agents, inflammation, drug hypersensitivity, or underlying disease. C3327 Skin Discoloration 2074 FDA C54450 FDA Patient Problem Code Hierarchy C50841 Esophagus, Laceration(s) Of 2398 Laceration(s) Of Esophagus A torn, ragged, mangled wound, or an accidental cut of esophagus. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50693 Esophagus, Perforation Of 2399 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50553 Exit Block 2628 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) C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50856 Exsanguination 1841 Extensive loss of blood due to internal or external hemorrhage. Extensive loss of blood due to internal or external hemorrhage. C50470 Blood Loss 2597 FDA C54450 FDA Patient Problem Code Hierarchy C48198 Extravasation 1842 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50556 Extreme Exhaustion 1843 Exhaustion, Extreme Extreme fatigue; inability to respond to stimuli. Extreme fatigue; inability to respond to stimuli. C3036 Fatigue 1849 FDA C54450 FDA Patient Problem Code Hierarchy C50819 Extubate 2402 The removal of a previously inserted tube from a hollow organ or passageway, often from the airway. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C34602 Eye Injury 1845 Injury, Eye Damage to the eye. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26769 Facial Nerve Paralysis 1846 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50857 Fainting 1847 Extremely weak; threatened with syncope. Extremely weak; threatened with syncope. C50635 Loss Of Consciousness 2418 FDA C54450 FDA Patient Problem Code Hierarchy C50558 Fall 1848 A sudden movement downward, usually resulting in injury. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50559 Fasciitis 2375 Inflammation of fascia. Inflammation process in fascia. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3036 Fatigue 1849 Overall tiredness and lack of energy. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50560 Feeding Problems 1850 Problems, Feeding C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50563 Fetal Distress 1856 Distress, Fetal Signs or symptoms which may be indicative of distress to a fetus, which may include repetitive variable decelerations, fetal tachycardia or bradycardia, late decelerations, or low biophysical profile. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3038 Fever 1858 Elevation of body temperature above normal due to inflammatory or immune responses. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50566 Fibromyositis 1860 Inflammation and fibrous degeneration of a muscle. Inflammation and fibrous degeneration of a muscle. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3044 Fibrosis 3167 The formation of fibrous tissue; fibroid or fibrous degeneration. The formation of fibrous tissue. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50532 First Use Syndrome 2239 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C76130 First-Degree Burn 2685 A burn that only affects the outer layer of skin causing pain, redness, and swelling. A painful injury to the epidermis due to chemical, friction, radiation or thermal exposure. The affected area appears red and blanches when touched. C34441 Burn(s) 1757 FDA C54450 FDA Patient Problem Code Hierarchy C3045 Fistula 1862 Abnormal epithelial-lined communication between two anatomical structures. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50568 Flashers 1864 A sudden or brief burst of light. The perception of sudden or brief bursts (flashes) of light. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50569 Flatus 1865 Gas or air in the gastrointestinal tract. Gas or air in the gastrointestinal tract. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C34548 Fluid Discharge 2686 The pouring forth of a fluid. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50524 Forced Expiratory Volume, Decreased 2430 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50609 Forced Expiratory Volume, Increased 2431 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C34620 Foreign Body In Patient 2687 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. Extraneous material within the body. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50444 Foreign Body Reaction 1868 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50572 Foreign Body Sensation 1869 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3046 Fracture(s) 1870 A traumatic injury to the bone in which the continuity of the bone is broken. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C27783 Fracture, Arm 2351 A traumatic break in one or more of the bones in the arm or forearm. C3046 Fracture(s) 1870 FDA C54450 FDA Patient Problem Code Hierarchy C50529 Fracture, Delayed Union 2369 Delayed Union Fracture|Union Fracture, Delayed A bone fracture that is taking an abnormally long time to heal. C3046 Fracture(s) 1870 FDA C54450 FDA Patient Problem Code Hierarchy C26794 Fracture, Hip 2349 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 Fracture(s) 1870 FDA C54450 FDA Patient Problem Code Hierarchy C50745 Fracture, Skull 2077 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 Fracture(s) 1870 FDA C54450 FDA Patient Problem Code Hierarchy C50777 Fracture, Tooth 2428 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 Fracture(s) 1870 FDA C54450 FDA Patient Problem Code Hierarchy C14209 Fungus 1872 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). C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50573 Gangrene 1873 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26780 Gastritis 1874 Inflammation of the stomach. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26782 Glaucoma 1875 Increased pressure in the eyeball due to obstruction of the outflow of aqueous humor. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3064 Granuloma 1876 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C52352 Great Vessel Perforation 2152 Perforation, Great Vessel C50804 Vessels, Perforation Of 2135 FDA C54450 FDA Patient Problem Code Hierarchy C50575 Hair Loss 1877 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50806 Halo 2227 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 Blurred Vision 2137 FDA C54450 FDA Patient Problem Code Hierarchy C34660 Head Injury 1879 Injury, Head A traumatic injury to the head. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C34661 Headache 1880 Pain in various parts of the head, not confined to the area of distribution of any nerve. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50643 Headache, Lumbar Puncture 2186 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50601 Healing, Impaired 2378 Impaired Healing Improper body tissue repair due to factors affecting one or more of the phases of wound healing, including hemostasis, inflammation, proliferation, and remodeling. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50576 Hearing Impairment 1881 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C35731 Hearing Loss 1882 Loss Of Hearing A partial or complete loss of hearing in one or both ears. It is classified as conductive, sensory, or central. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50577 Heart Failure 2206 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C34670 Heartburn 1883 Abdominal discomfort with retrosternal pain usually associated with gastroesophageal reflux.. C3303 Pain 1994 FDA C54450 FDA Patient Problem Code Hierarchy C50578 Heavier Menses 2666 C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50579 Hematoma 1884 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3090 Hematuria 2558 Blood in the urine. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50580 Hemoconcentration 1288 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C37965 Hemolysis 1886 Disruption of the integrity of the erythrocyte membrane causing release of hemoglobin. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C34376 Hemolytic Anemia 2279 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3094 Hemoptysis 1887 Coughing up blood from the respiratory tract. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26791 Hemorrhage 1888 Bleeding The flow of blood from a ruptured blood vessel. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50485 Hemorrhage, Cerebral 1889 Bleeding, Cerebral|Cerebral Bleeding|Cerebral Hemorrhage Hemorrhage into the cerebrum. See also Stroke Syndrome. Bleeding within the cerebrum. C50438 Intracranial Hemorrhage 1891 FDA C54450 FDA Patient Problem Code Hierarchy C50555 Hemorrhage, Extradural 1890 Extradural Hemorrhage Intracranial hemorrhage into the epidural space. Intracranial hemorrhage into the epidural space. C26791 Hemorrhage 1888 FDA C54450 FDA Patient Problem Code Hierarchy C50896 Hemorrhage, Intraventricular 1892 Intraventricular Hemorrhage Bleeding into the brain's ventricles. C50485 Hemorrhage, Cerebral 1889 FDA C54450 FDA Patient Problem Code Hierarchy C50757 Hemorrhage, Subarachnoid 1893 Subarachnoid Hemorrhage Intracranial hemorrhage into the subarachnoid space. Intracranial hemorrhage into the subarachnoid space. C26791 Hemorrhage 1888 FDA C54450 FDA Patient Problem Code Hierarchy C50759 Hemorrhage, Subdural 1894 Subdural Hemorrhage Cerebral hemorrhage into the subdural space. See also Stroke Syndrome. Bleeding between the dura mater and the brain, usually secondary to a tear of the bridging vein. C26791 Hemorrhage 1888 FDA C54450 FDA Patient Problem Code Hierarchy C50761 Hemorrhage, Subgaleal 2603 Hemorrhage, Subgaleal Bleeding between the scalp and the periosteum. C26791 Hemorrhage 1888 FDA C54450 FDA Patient Problem Code Hierarchy C50581 Hemostasis 1895 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50582 Hemothorax 1896 A collection of blood in the pleural cavity. A collection of blood in the pleural cavity. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3095 Hepatitis 1897 Inflammation of the liver; usually from a viral infection, but sometimes from toxic agents. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C34685 Hernia 2240 The protrusion of part of an organ or fibroadipose tissue through an abnormal opening. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50583 Herpes 1898 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 Infection, Viral 2248 FDA C54450 FDA Patient Problem Code Hierarchy C37966 Hiccups 1899 An involuntary contraction of the diaphragm against closed vocal cords, producing the "hic" sound. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C14219 HIV, Human Immunodeficiency Virus 2197 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50586 Host-Tissue Reaction 1297 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 Foreign Body Reaction 1868 FDA C54450 FDA Patient Problem Code Hierarchy C3109 Hot Flashes 2153 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3111 Hydrocephalus 3272 A disorder characterized by an abnormal increase of cerebrospinal fluid in the ventricles of the brain. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C27088 Hyperbilirubinemia 1903 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50588 Hyperemia 1904 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26797 Hyperglycemia 1905 Blood Glucose, High|Glucose, High Blood|High Blood Glucose Abnormally high level of glucose in the blood. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C37970 Hypernatremia 2242 Higher than normal levels of sodium in the circulating blood. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3113 Hyperplasia 1906 An abnormal increase in the number of cells in an organ or a tissue with consequent enlargement. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3114 Hypersensitivity 1907 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. An immune response that occurs following exposure to an innocuous antigen, but that does not require the presence of preformed antibodies to the antigen. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3117 Hypertension 1908 Blood Pressure, High|Blood Pressure, Increased|High Blood Pressure|Increased Blood Pressure|Pressure, High Blood Blood pressure that is abnormally high. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50589 Hyperthermia 1909 A condition characterized by an abnormally high body temperature. In a 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50590 Hyperventilation 1910 Abnormally prolonged, rapid, and deep breathing. Abnormally prolonged, rapid, and deep breathing. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50591 Hypervolemia 2664 Too much fluid in the blood. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50592 Hyphema 1911 Hemorrhage within the anterior chamber of the eye; bloodshot. Hemorrhage within the anterior chamber of the eye; bloodshot. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50445 Hypoesthesia 2352 Consisting of abnormally decreased sensitivity, particularly to touch. Impairment of tactile sensitivity manifesting as partial loss of sensitivity to sensory stimuli. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50463 Hypoesthesia, Arm/Hand 2353 Consisting of abnormally decreased sensitivity, particularly to touch. Consisting of abnormally decreased sensitivity, particularly to touch in the arm or hand. C50445 Hypoesthesia 2352 FDA C54450 FDA Patient Problem Code Hierarchy C50571 Hypoesthesia, Foot/Leg 2354 Foot/Leg Hypoesthesia|Leg/Foot Hypoesthesia Consisting of abnormally decreased sensitivity, particularly to touch. Consisting of abnormally decreased sensitivity, particularly to touch in the foot or leg. C50445 Hypoesthesia 2352 FDA C54450 FDA Patient Problem Code Hierarchy C3126 Hypoglycemia 1912 Blood Glucose, Low|Glucose, Low Blood|Low Blood Glucose Abnormally low level of glucose in the blood. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50593 Hypopyon 1913 An accumulation of pus in the anterior chamber of the eye. An accumulation of pus in the anterior chamber of the eye. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3128 Hypotension 1914 Blood Pressure, Decreased|Blood Pressure, Low|Decreased Blood Pressure|Low Blood Pressure|Pressure, Low Blood Blood pressure that is abnormally low. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50523 Hypothermia 1915 Body Temperature, Decreased|Decreased Body Temperature|Temperature, Decreased Body Abnormally low body temperature. Abnormally low body temperature. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50594 Hypoventilation 1916 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50595 Hypovolemia 2243 Abnormally decreased volume of circulating fluid (plasma) in body. Abnormally decreased volume of circulating fluid (plasma) in body. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3890 Hypoxia 1918 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). C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50564 Hypoxia In Utero 2210 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 Hypoxia 1918 FDA C54450 FDA Patient Problem Code Hierarchy C50598 Iatrogenic Source 2498 Source, Iatrogenic C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50599 Idioventricular Rhythm 1923 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) C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3131 Immuno-Deficiency 2156 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50603 Implant, Failure Of 1924 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. Malfunction of a medical implant. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3133 Impotence 1925 Persistent or recurrent inability to achieve or to maintain an erection during sexual activity. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50914 Inadequate Osteointegration 2646 Insufficient structural and functional connection between living bone and the surface of a synthetic implant. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50607 Incompetent Cervix 1927 Cervix, Incompetent One that is abnormally prone to dilate in the second trimester of pregnancy, resulting in premature expulsion of the fetus. A clinical diagnosis presenting with painless cervical dilatation and spontaneous mid-trimester birth in recurrent pregnancies in the absence of spontaneous membrane rupture, bleeding or clinical chorioamnionitis. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3429 Incontinence 1928 Involuntary passage of stool or urine from the body. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C73503 Increased Sensitivity 2065 Sensitivity C25637 Reaction 2414 FDA C54450 FDA Patient Problem Code Hierarchy C50486 Infarction, Cerebral 1771 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26726 Infection 1930 A disorder resulting from the presence and activity of a microbial, viral, fungal, or parasitic agent. It can be transmitted by direct or indirect contact. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C2890 Infection, Bacterial 1735 Bacterial Infection An acute infectious disorder that is caused by gram positive or gram negative bacteria; representative examples include pneumococcal, streptococcal, salmonella, and meningeal infections. C26726 Infection 1930 FDA C54450 FDA Patient Problem Code Hierarchy C50534 Infection, Direct 2244 Direct Infection Infection produced by direct contact with another person. Infection produced by direct contact with another person. C26726 Infection 1930 FDA C54450 FDA Patient Problem Code Hierarchy C3245 Infection, Fungal 2419 Fungal Infection An infection caused by a fungus. C26726 Infection 1930 FDA C54450 FDA Patient Problem Code Hierarchy C50612 Infection, Indirect 2245 Indirect Infection Infection transmitted by water, food or other means of conveyance. Infection transmitted by water, food or other means of conveyance. C26726 Infection 1930 FDA C54450 FDA Patient Problem Code Hierarchy C50617 Infection, Intraocular 1933 Intraocular Infection Infection within the eye. Infection within the eye. C26726 Infection 1930 FDA C54450 FDA Patient Problem Code Hierarchy C50719 Infection, Pyrogenic 2246 Pyrogenic Infection An infection caused by pus-producing organisms. An infection caused by pus-producing organisms. C26726 Infection 1930 FDA C54450 FDA Patient Problem Code Hierarchy C50758 Infection, Subclinical 2247 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 Infection 1930 FDA C54450 FDA Patient Problem Code Hierarchy C35650 Infection, Upper Respiratory Tract 2420 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 Infection 1930 FDA C54450 FDA Patient Problem Code Hierarchy C50791 Infection, Urinary Tract 2120 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 Infection 1930 FDA C54450 FDA Patient Problem Code Hierarchy C3439 Infection, Viral 2248 Viral Infection Any disease caused by a virus. C26726 Infection 1930 FDA C54450 FDA Patient Problem Code Hierarchy C25754 Infiltration Of Tissue 1931 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) C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3137 Inflammation 1932 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3671 Injury 2348 Damage inflicted on the body as the direct or indirect result of an external force, with or without disruption of structural continuity. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50796 Insufficiency, Valvular 1926 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C53269 Insufficient Information 3190 IMDRF:A26 No Answer Provided An adverse event appears to have occurred but there is not yet enough information available to classify the device problem. Information regarding the subject is unknown or inaccessible at this time. C54451 FDA Device Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C34818 Intermenstrual Bleeding 2665 Uterine bleeding that occurs during a time not associated with the normal menstrual period. C26791 Hemorrhage 1888 FDA C54450 FDA Patient Problem Code Hierarchy C50616 Intimal Dissection 1333 Dissection, Intimal Pertaining to the inner layer of the blood vessels. A dissection of an artery that occurs though a tear in the inner lining of the blood vessel. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50438 Intracranial Hemorrhage 1891 Bleeding, Intracranial|Hemorrhage, Intracranial|Intracranial Bleeding Bleeding within the cranium. Bleeding within the cranium. C26791 Hemorrhage 1888 FDA C54450 FDA Patient Problem Code Hierarchy C50618 Intraocular Pressure Rise 1937 IOPR, Intraocular Pressure Rise|Intraocular Pressure Rise, (IOPR)|Pressure (IOPR), Rise In Intraocular|Rise In Intraocular Pressure, (IOPR) Increase of pressure of the intraocular fluid in the eye. Increased pressure of the intraocular fluid in the eye. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50786 Intraocular Pressure, Delayed, Uncontrolled 1936 Delayed, Uncontrolled Intraocular Pressure (IOP)|IOP (Intraocular Pressure), Delayed, Uncontrolled|IOP Delayed, Uncontrolled|Intraocular Pressure (IOP), Delayed, Uncontrolled|Pressure (IOP), Delayed Uncontrolled Intraocular|Uncontrolled/Delayed Intraocular Pressure (IOP) Changes in the fluid pressure inside the eye. Changes in the fluid pressure inside the eye. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50619 Intraoperative Pain 2662 C3303 Pain 1994 FDA C54450 FDA Patient Problem Code Hierarchy C50621 Iritis 1940 Inflammation of the iris. Inflammation of the iris. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50623 Irritability 2421 Excited response to stimuli. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50624 Irritation 1941 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C34738 Ischemia 1942 Lack of blood supply to an area of the body, resulting in impairment of tissue oxygenation. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50625 Ischemic Heart Disease 2493 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). C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3344 Itching 1943 An intense itching sensation. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3143 Jaundice 2187 Yellow pigmentation of the skin, mucous membranes, and the eyes due to hyperbilirubinemia. Causes include liver disease, biliary tract obstruction, and hemolysis. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26750 Joint Dislocation 2374 Dislocated Joint An abnormal separation where two or more bones meet. C35760 Joint Disorder 2373 FDA C54450 FDA Patient Problem Code Hierarchy C35760 Joint Disorder 2373 Disorder, Joint Any disorder of the joints. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50627 Joint Swelling 2356 Swelling, Joint The presence of swelling in a joint. C35760 Joint Disorder 2373 FDA C54450 FDA Patient Problem Code Hierarchy C26805 Keratitis 1944 Inflammation of the cornea. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50450 Keratitis, Acanthamoeba 1945 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 Keratitis 1944 FDA C54450 FDA Patient Problem Code Hierarchy C50917 Labor, Premature 2465 Premature Labor Regular uterine activity with associated cervical change prior to 37 weeks gestation. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50446 Laceration(s) 1946 A cut or tear in any tissue. C3671 Injury 2348 FDA C54450 FDA Patient Problem Code Hierarchy C61390 Lead(s), Burn(s) From 3161 C34441 Burn(s) 1757 FDA C54450 FDA Patient Problem Code Hierarchy C61392 Lead(s), Shock From 3162 C35016 Shock 2072 FDA C54450 FDA Patient Problem Code Hierarchy C50629 Left Ventricular Dysfunction 1947 Dysfunction, Left Ventricular|Ventricular Dysfunction, Left Impairment of the left ventricle to either fill or eject adequately. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50630 Left Ventricular Failure 1948 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 Heart Failure 2206 FDA C54450 FDA Patient Problem Code Hierarchy C50631 Left Ventricular Hypertrophy 1949 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50412 Lethargic 2560 Characterized by a lack of vitality or energy. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50633 Ligament(s), Damage To 1952 Damage To Ligament(s) An injury to any of the fibrous bands of tissue that comprise an articulation (joint). C3671 Injury 2348 FDA C54450 FDA Patient Problem Code Hierarchy C50909 Limited Mobility Of The Implanted Joint 2671 C50603 Implant, Failure Of 1924 FDA C54450 FDA Patient Problem Code Hierarchy C50853 Liver Contusion 1953 Contusion, Liver Bruising of the liver. Bruising of the liver. C50441 Contusion 1787 FDA C54450 FDA Patient Problem Code Hierarchy C50634 Liver Dysfunction 1954 Dysfunction, Liver A finding that indicates abnormal liver function. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50854 Liver Laceration(s) 1955 Laceration(s), Liver A cut or tear in the liver. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50635 Loss Of Consciousness 2418 An inability to purposefully respond to stimuli. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50636 Loss Of Pulse 2562 Pulse, Loss Of C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50641 Low Cardiac Output 2501 Cardiac Output, Low|Output, Low Cardiac A below normal volume of blood pumped from the right or left ventricle of the heart per unit time. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50644 Lung, Overinflation Of 2397 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C27153 Lupus 1956 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 Autoimmune Disease 1732 FDA C54450 FDA Patient Problem Code Hierarchy C3208 Lymphoma 3263 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 Cancer 3262 FDA C54450 FDA Patient Problem Code Hierarchy C3832 Malaise 2359 A feeling of general discomfort or uneasiness, an out-of-sorts feeling. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50431 Mammogram, Abnormal 2370 Abnormal Mammogram A radiologic finding indicating the presence of abnormalities in the breast parenchyma identified in a mammogram performed for screening or diagnostic purposes. These abnormalities include calcifications, breast tissue distortion, presence of areas of density, and presence of benign or malignant tumors. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50645 Mediastinal Shift 2198 Shift, Mediastinal Normal location of the mediastinum changes to the right or left, depending upon the underlying cause. Displacement of structures in the thoracic cavity in one direction due to increased pleural pressure on the contralateral side. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C2867 Memory Loss 1958 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26828 Meningitis 2389 A disorder characterized by acute inflammation of the meninges of the brain and/or spinal cord. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C35219 Menstrual Irregularities 1959 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50549 Microcysts, Epithelial 2232 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50792 Micturation Urgency 1871 A sudden compelling urge to urinate. An acute and compelling urge to urinate. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C34336 Miscarriage 1962 Loss of the products of conception from the uterus before the fetus is viable; spontaneous abortion. Fetal loss at less than 20 weeks of gestation. C35221 Abortion 1688 FDA C54450 FDA Patient Problem Code Hierarchy C50432 Misdiagnosis 2159 C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50429 Missed Dose 2561 Dose, Missed A dose of medicine that was not taken at the prescribed dosing interval. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C48655 Missing Value Reason 3192 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50888 Mitral Insufficiency 1963 Insufficiency, Mitral Dysfunction of the mitral valve characterized by incomplete valve closure. C50796 Insufficiency, Valvular 1926 FDA C54450 FDA Patient Problem Code Hierarchy C50653 Mitral Perforation 2512 Perforation, Mitral A rupture in the mitral valve tissue due to traumatic or pathologic processes. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50852 Mitral Regurgitation 1964 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 Mitral Insufficiency 1963 FDA C54450 FDA Patient Problem Code Hierarchy C50654 Mitral Stenosis 1965 Stenosis, Mitral Narrowing of the left atrioventricular mitral orifice. Narrowing of the left atrioventricular mitral orifice. C62433 Valvular Stenosis 2697 FDA C54450 FDA Patient Problem Code Hierarchy C50655 Mitral Valve Prolapse 2471 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 Prolapse 2475 FDA C54450 FDA Patient Problem Code Hierarchy C75568 Multiple Organ Failure 3261 A progressive condition usually characterized by combined failure of the lungs, liver, kidney, and clotting mechanisms. Complete impairment of two or more organs or organ systems. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50656 Muscle Spasm(s) 1966 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50657 Muscle Stimulation 1412 Stimulation Of Muscle C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50658 Muscle Weakness 1967 Weakness, Muscular A reduction in the strength of one or more muscles. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50659 Muscular Rigidity 1968 Rigidity, Muscular Stiffness or inflexibility. An involuntary, persistent state of firm, tense muscles with marked resistance to passive movement. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50660 Muscular Tics 2161 An involuntary, compulsive, repetitive stereotyped movement, usually of the face or shoulders. An involuntary, compulsive, repetitive stereotyped movement, usually of the face or shoulders. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C27009 Myalgia 2238 Painful sensation originating from a muscle or group of muscles. C3303 Pain 1994 FDA C54450 FDA Patient Problem Code Hierarchy C50661 Myocardial Contusion 1763 Cardiac Contusion|Contusion, Cardiac|Contusion, Myocardial A bruise to the heart. A bruise to the heart. C50441 Contusion 1787 FDA C54450 FDA Patient Problem Code Hierarchy C27996 Myocardial Infarction 1969 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C34831 Myocarditis 2470 Inflammation of the muscle tissue of the heart. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50662 Nasal Obstruction 2466 Obstruction, Nasal Blockage of the nasal passages. C3284 Obstruction 2422 FDA C54450 FDA Patient Problem Code Hierarchy C3258 Nausea 1970 Upper abdominal discomfort associated with an urge to vomit. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C16897 Necrosis 1971 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50567 Necrosis Of Flap Tissue 1972 Flap Tissue, Necrosis Of|Tissue, Necrosis Of Flap C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50665 Needle Stick/Puncture 2462 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50666 Neonatal Deformities 1974 Deformities, Neonatal A congenital anatomic abnormality manifested during the neonatal period. C2849 Congenital Defect/Deformity 1782 FDA C54450 FDA Patient Problem Code Hierarchy C50667 Neonatal Hearing Impairment 1975 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 Congenital Defect/Deformity 1782 FDA C54450 FDA Patient Problem Code Hierarchy C50668 Neonatal Hearing Loss 1976 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 Congenital Defect/Deformity 1782 FDA C54450 FDA Patient Problem Code Hierarchy C16900 Neovascularization 1978 The formation of new or recent blood vessels. The vasculature network is critical to the development of neoplasms. As the tumor burden grows, vascular endothelial cells are recruited to form new blood vessels as an increased demand for blood and nourishment is required. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50669 Nerve Damage 1979 Damage To Nerve(s) Injury to nervous tissue. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50915 Nerve Proximity Nos (Not Otherwise Specified) 2647 C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50787 Nerve Stimulation, Undesired 1980 Stimulation Of Nerve, Undesired|Undesired Nerve Stimulation C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C4974 Nervous System Injury 2689 Injury in the central or peripheral nervous system. C3671 Injury 2348 FDA C54450 FDA Patient Problem Code Hierarchy C50672 Neurological Deficit/Dysfunction 1982 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C4731 Neuropathy 1983 A disorder affecting the cranial nerves or the peripheral nervous system. It manifests 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50673 Nipple Sensation, Changes In/Loss Of 2162 Changes In/Loss Of Nipple Sensation|Loss Of/Changes In Nipple Sensation|Sensation, Changes In/Loss Of Nipple C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50674 Nipple Ulceration 2441 Ulceration, Nipple Ulcer that develops in the nipple. Causes include trauma and Paget disease. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C48660 No Apparent Adverse Event 3189 IMDRF:A25 A report has been received but the description provided does not appear to relate to an adverse event. This code allows a report to be recorded for administration purposes, even if it doesn't meet the requirements for adverse event reporting.|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. C54451 FDA Device Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50675 No Consequences Or Impact To Patient 2199 Consequences Or Impact To Patient, None|Impact Or Consequences To Patient, None|Patient, No Consequences Or Impact To C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C76143 No Known Impact Or Consequence To Patient 2692 C48655 Missing Value Reason 3192 FDA C54450 FDA Patient Problem Code Hierarchy C50912 No Patient Involvement 2645 C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50405 Nonpyrogenic 2250 C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C34857 Numbness 2415 A loss of the sensation of feeling in an area of the body. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3284 Obstruction 2422 Blockage of the normal flow of the contents of an anatomical passageway. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50678 Occlusion 1984 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 Obstruction 2422 FDA C54450 FDA Patient Problem Code Hierarchy C50849 Optical Nerve Damage 1986 Damage To Optical Nerve(s)|Nerve Damage, Optical C50669 Nerve Damage 1979 FDA C54450 FDA Patient Problem Code Hierarchy C50475 Optical Tissue, Breakdown Of 2106 Tissue, Breakdown Of Optical C34602 Eye Injury 1845 FDA C54450 FDA Patient Problem Code Hierarchy C50679 Organ(s), Perforation Of 1987 Perforation Of Organ(s) C4080 Perforation 2001 FDA C54450 FDA Patient Problem Code Hierarchy C50680 Ossification 1428 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50681 Osteolysis 2377 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50910 Osteopenia 2651 Bone Loss Decreased calcification or density of bone tissue. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50873 Overdose 1988 Exposure to, or intake of, an excessive amount of a substance. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50850 Oversedated 1990 A level of sedation that is greater than the intended level. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50683 Overstimulation 1991 C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50504 Overwear Syndrome 2234 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50584 Oxygen Saturation, High 2478 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50640 Oxygen Saturation, Low 2477 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3303 Pain 1994 The sensation of discomfort, distress, or agony, resulting from the stimulation of specialized nerve endings. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50605 Pain Relief, Inadequate 2388 Inadequate Pain Relief C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26682 Pain, Abdominal 1685 Abdominal Pain Painful sensation in the abdominal region. C3303 Pain 1994 FDA C54450 FDA Patient Problem Code Hierarchy C50663 Pain, Neck 2433 Neck Pain Painful sensation in the neck area. C3303 Pain 1994 FDA C54450 FDA Patient Problem Code Hierarchy C50685 Pallor 2468 An unusual or extreme paleness, state of decreased skin or mucosal coloration. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C37999 Palpitations 2467 An unpleasant sensation of irregular and/or forceful beating of the heart. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50686 Pannus Formation 1447 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3310 Paralysis 1997 Partial or complete loss of function of one or more muscles. It is usually caused by damage to the nervous system. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50687 Paraplegia 2448 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50688 Paresis 1998 A slight or incomplete paralysis. A slight or incomplete paralysis. C3310 Paralysis 1997 FDA C54450 FDA Patient Problem Code Hierarchy C61389 Patch Test, Abnormal Results Of 3166 C36292 Test Result 2695 FDA C54450 FDA Patient Problem Code Hierarchy C50525 Peak Expiratory Flowrate, Decreased 2435 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50610 Peak Expiratory Flowrate, Increased 2436 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50691 Peeling 1999 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3889 Pelvic Inflammatory Disease 2000 Disease (PID), Pelvic Inflammatory|Inflammatory Disease (PID), Pelvic|PID, Pelvic Inflammatory Disease|Pelvic Inflammatory Disease, (PID) Any pelvic infection involving the upper female genital tract beyond the cervix. Pelvic inflammatory disease (PID) is an acute or chronic inflammation in the pelvic cavity. It is most commonly caused by sexually transmitted diseases, including chlamydia and gonorrhea that have ascended into the uterus, fallopian tubes, or ovaries as a result of intercourse or childbirth, or of surgical procedures, including insertion of IUDs or abortion. PID may be either symptomatic or asymptomatic. It may cause infertility and it may raise the risk of ectopic pregnancy. PID is a disease associated with HIV infection. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C4080 Perforation 2001 A hole or opening made through a membrane or other tissue or material. C3671 Injury 2348 FDA C54450 FDA Patient Problem Code Hierarchy C3319 Pericardial Effusion 3271 Fluid collection within the pericardial sac, usually due to inflammation. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C73501 Perinatal Brain Injury 1852 Injury occurring as a result of the delivery process. Injury to the brain of a newborn infant occurring around the time of birth. C50440 Brain Injury 2219 FDA C54450 FDA Patient Problem Code Hierarchy C35136 Peripheral Vascular Disease 2002 Disease, Peripheral Vascular|Vascular Disease, Peripheral Any disorder affecting blood flow through the veins or arteries outside of the heart. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50695 Peritoneal Laceration(s) 2003 Laceration(s), Peritoneal A cut or tear of the peritoneum. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26849 Peritonitis 2252 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C27061 Peroneal Nerve Palsy 2362 Nerve Palsy, Peroneal|Palsy, Peroneal Nerve Paralysis of the nerves located in the legs. Paralysis of the nerves located in the legs. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26851 Pharyngitis 2367 Inflammation of the throat most often caused by viral and bacterial infections. Other causes include allergens, chemical substances, and trauma. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C38003 Phlebitis 2004 Inflammation of a vein. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50697 Phosphene Visualization 2164 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50698 Phototoxicity 2165 A nonimmunologic, chemically induced type of photosensitivity. A nonimmunologic, chemically induced type of photosensitivity. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50548 Physical Entrapment 2327 Patient becomes entangled or caught in a bed, particularly in side rails, or mattress, or head/foot boards. Patient becomes entangled or caught in a bed, particularly in side rails, or mattress, or head/foot boards. C3671 Injury 2348 FDA C54450 FDA Patient Problem Code Hierarchy C17000 Pleomorphism 2009 Having different forms at different stages of the life cycle. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3331 Pleural Effusion 2010 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3333 Pneumonia 2011 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C38006 Pneumothorax 2012 Abnormal presence of air in the pleural cavity. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50699 Pocket Erosion 2013 Erosion, Pocket Erosion of patient's skin pocket which houses a device. Erosion of patient's skin pocket which houses a device. C50443 Erosion 1750 FDA C54450 FDA Patient Problem Code Hierarchy C50700 Polydipsia 2604 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26925 Polymyositis 1992 An idiopathic inflammatory disorder affecting the muscles. It presents with symmetrical proximal muscle weakness and elevated skeletal muscle enzymes. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50701 Positive Antinuclear Antibodies (ANA) 2015 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C25742 Pregnancy 3193 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C34945 Pregnancy, Ectopic 1819 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 conception is implanted outside the endometrial cavity. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50706 Pressure Sores/Ulcers 2326 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 Ulcer 2274 FDA C54450 FDA Patient Problem Code Hierarchy C36173 Prolapse 2475 A condition in which an organ or body tissue drops or bulges out of place. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50711 Pseudoaneurysm 2605 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C27298 Ptosis 2620 The drooping of the upper eyelid. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50585 Pulmonary Arterial Wedge Pressure, High 2480 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50642 Pulmonary Arterial Wedge Pressure, Low 2479 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50677 Pulmonary Arterial Wedge Pressure, Normal 2481 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50712 Pulmonary Dysfunction 2019 Dysfunction, Pulmonary C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26868 Pulmonary Edema 2020 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). C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50713 Pulmonary Embolism 1498 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 Embolism 1829 FDA C54450 FDA Patient Problem Code Hierarchy C50714 Pulmonary Infarction 2021 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C51447 Pulmonary Insufficiency 2022 Insufficiency, Pulmonary Impairment of gas exchange within the lungs secondary to a disease process, neoplasm, or trauma, possibly resulting in hypoxia, hypercarbia, or both, but not requiring intubation or mechanical ventilation. Patients are normally managed with pharmaceutical therapy, supplemental oxygen, or both. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50848 Pulmonary Regurgitation 2023 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50715 Pulmonary Stenosis 2024 Stenosis, Pulmonary Narrowing of the opening between the pulmonary artery and the right ventricle, usually at the level of the valve leaflets. Narrowing of the opening between the pulmonary artery and the right ventricle, usually at the level of the valve leaflets. C62433 Valvular Stenosis 2697 FDA C54450 FDA Patient Problem Code Hierarchy C50533 Pulse Pressure, Diminished 2606 Pulse, Diminished Weak or absent palpable pulse due to decreased arterial pulse pressure. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50622 Pulse, Irregular 2469 Irregular Pulse A pulse that beats at irregular intervals. Not rhythmic pulse irregular in beat or accent. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50716 Pupillary Block 2026 Block, Pupillary An obstruction of the pupil. An obstruction of the pupil. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50717 Purulent Discharge 1812 Discharge, Purulent Consisting of or containing pus; associated with the formation of or caused by pus. Pus-containing fluid that is draining from an orifice or wound. C34548 Fluid Discharge 2686 FDA C54450 FDA Patient Problem Code Hierarchy C50721 Quadriplegia 2449 Paralysis of all four limbs. Paralysis of all four limbs. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C61395 R On T Phenomenon 3163 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) C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50722 Radiation Burn 1755 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 Burn(s) 1757 FDA C54450 FDA Patient Problem Code Hierarchy C61401 Radiation Exposure, Unintended 3164 C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50862 Radiation Overdose 1510 Overdose Of Radiation A higher than intended cumulative dose of radiation to a single field. C50873 Overdose 1988 FDA C54450 FDA Patient Problem Code Hierarchy C50723 Radiation Sickness Syndrome 2256 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). C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C52354 Radiation Underdose 2166 Underdose, Radiation An inadequate amount of a radiation treatment. C50428 Underdose 2542 FDA C54450 FDA Patient Problem Code Hierarchy C3349 Radiodermatitis 2255 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 Skin Inflammation 2443 FDA C54450 FDA Patient Problem Code Hierarchy C50637 Range Of Motion, Loss Of 2032 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C39594 Rash 2033 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50724 Raynauds Phenomenon 2034 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. An episodic vasoconstriction resulting in discoloration of the skin and pain in the affected areas, often involving fingers or toes. Classically associated with triphasic color changes (white, blue, red) but may be biphasic. Often occurs in response to cold temperatures or emotional stress. May be primary or secondary to an underlying autoimmune disease. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C25637 Reaction 2414 A response generated by a stimulus. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3508 Reaction, Injection Site 2442 Injection Site Reaction An intense reaction (usually immunologic) developing at the site of injection C25637 Reaction 2414 FDA C54450 FDA Patient Problem Code Hierarchy C50419 Reaction, Local 2035 Local Reaction A regionally-limited response to an antigen, which may include inflammation, induration, erythema, pruritus or pain. C25637 Reaction 2414 FDA C54450 FDA Patient Problem Code Hierarchy C50725 Red Eye(s) 2038 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50726 Regurgitation 2259 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50797 Regurgitation, Valvular 2335 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 Insufficiency, Valvular 1926 FDA C54450 FDA Patient Problem Code Hierarchy C50820 Reinfusion 2403 The infusion of autogenic body fluid that has previously been withdrawn from the patient. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C9439 Renal Disease, End Stage 2039 Disease (ESRD), End Stage Renal|ESRD, End Stage Renal Disease|End Stage Renal Disease (ESRD)|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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C4376 Renal Failure 2041 Failure, Renal An acute or chronic condition that is characterized by the inability of the kidneys to adequately filter the blood. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50727 Reocclusion 1985 C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50728 Respiratory Acidosis 2482 Acidosis, Respiratory A state due to excess retention of carbon dioxide in the body. A condition in which the blood pH is less than normal, secondary to impaired gas exchange. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50729 Respiratory Alkalosis 2483 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. A condition in which the blood pH is greater than normal, secondary to impaired gas exchange. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C27165 Respiratory Distress 2045 Distress, Respiratory A pathological increase in the effort and frequency of breathing movements. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C27560 Respiratory Distress Syndrome Of Newborns 2046 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 beginning in the first day of life that results from inadequate surfactant production, causing increased work of breathing and impaired gas exchange. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26872 Respiratory Failure 2484 Failure, Respiratory The significant impairment of gas exchange within the lungs resulting in hypoxia, hypercarbia, or both, to the extent that organ tissue perfusion is severely compromised. Causes include chronic obstructive pulmonary disease, asthma, emphysema, acute respiratory distress syndrome, pneumonia, pulmonary edema, pneumothorax, and congestive heart failure. Treatment requires intubation and mechanical ventilation until the time the lungs recover sufficient function. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50474 Respiratory Rate, Decreased 2485 Decreased Respiratory Rate|Rate Of Respiration, Decreased Abnormal decrease of rate of breathing. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50767 Respiratory Rate, Increased 2486 Increased Respiratory Rate|Rate Of Respiration, Increased Abnormal increase of rate of breathing. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50731 Retina, Damage To 2048 Damage To Retina Injury to the retina due to advanced age, toxicity, exposure to bright lights, or trauma. C34602 Eye Injury 1845 FDA C54450 FDA Patient Problem Code Hierarchy C34979 Retina, Degeneration Of 2049 Degeneration Of Retina Degeneration of the retina. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50732 Retina, Tear(s) In 2050 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 Retina, Damage To 2048 FDA C54450 FDA Patient Problem Code Hierarchy C34882 Rheumatic Heart Disease 2053 Disease, Rheumatic Heart|Heart Disease, Rheumatic An autoinflammatory condition following an infection with Group A Beta Hemolytic Streptococcus (GABHS), in which the heart is attacked by antibodies formed in reaction to a recent GABHS infection. Chief anatomic changes of the valve include leaflet thickening, commissural fusion, and shortening and thickening of the tendinous cords, all of which can result in valvular dysfunction. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50733 Right Ventricular Dysfunction 2054 Dysfunction, Right Ventricular Impairment of the right ventricular function associated with low ejection fraction and decreased motility of the right ventricular wall. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50846 Right Ventricular Failure 2055 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 Right Ventricular Dysfunction 2054 FDA C54450 FDA Patient Problem Code Hierarchy C50734 Right Ventricular Hypertrophy 2056 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C9445 Rupture 2208 Forcible tearing or disruption of tissue. C3671 Injury 2348 FDA C54450 FDA Patient Problem Code Hierarchy C50827 Scar Excision 2358 Excision, Scar A surgical procedure to reduce the appearance of a scar. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50737 Scar Tissue 2060 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C34483 Scarring 2061 A permanent mark left on the skin in the process of wound healing. C3044 Fibrosis 3167 FDA C54450 FDA Patient Problem Code Hierarchy C26746 Scleroderma 2062 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 affects internal organs, including the heart, lungs, gastrointestinal tract, and kidneys. C2889 Autoimmune Disease 1732 FDA C54450 FDA Patient Problem Code Hierarchy C76131 Second-Degree Burn 2694 A partial thickness burn that affects both the outer and underlying layer of skin causing pain, redness, swelling and blistering. An injury that includes the entire epidermis and upper layers of the dermis due to a chemical, friction, radiation or thermal exposure. The affected area appears as moist red or white skin that does not blanch. Often it is painful with the presence of blisters. C34441 Burn(s) 1757 FDA C54450 FDA Patient Problem Code Hierarchy C21097 Sedation 2368 The process of allaying nervous excitement or the state of being calmed. (Taber's) C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C2962 Seizures 2063 Convulsion Sudden, involuntary skeletal muscular contractions of cerebral or brain stem origin. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50436 Seizures, Absence 2261 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 Seizures 2063 FDA C54450 FDA Patient Problem Code Hierarchy C50689 Seizures, Focal 2260 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 Seizures 2063 FDA C54450 FDA Patient Problem Code Hierarchy C50847 Seizures, Focal Motor 2064 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 Seizures, Focal 2260 FDA C54450 FDA Patient Problem Code Hierarchy C50574 Seizures, Grand-Mal 2168 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 Seizures 2063 FDA C54450 FDA Patient Problem Code Hierarchy C3364 Sepsis 2067 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50739 Seroma 2069 A tumor-like collection of serum in the tissues. A collection of serum in the body. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C38038 Shaking/Tremors 2515 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C35016 Shock 2072 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50452 Shock, Acoustic 1693 Acoustic Shock Neurophysiological and psychological symptoms caused by sudden and unexpected loud noise. C3671 Injury 2348 FDA C54450 FDA Patient Problem Code Hierarchy C50460 Shock, Anaphylactic 1703 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 Shock 2072 FDA C54450 FDA Patient Problem Code Hierarchy C50482 Shock, Cardiogenic 2262 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 Shock 2072 FDA C54450 FDA Patient Problem Code Hierarchy C50596 Shock, Hypovolemic 1917 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 Shock 2072 FDA C54450 FDA Patient Problem Code Hierarchy C50615 Shock, Insulin 2264 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 Shock 2072 FDA C54450 FDA Patient Problem Code Hierarchy C50671 Shock, Neurogenic 2265 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 Shock 2072 FDA C54450 FDA Patient Problem Code Hierarchy C50703 Shock, Postoperative 2266 Postoperative Shock A state of shock following a surgical operation. A state of shock following a surgical operation. C35019 Shock, Surgical 2267 FDA C54450 FDA Patient Problem Code Hierarchy C35018 Shock, Septic 2068 Septic Shock A state of acute circulatory failure characterized by persistent arterial hypotension despite adequate fluid resuscitation or by tissue hypoperfusion unexplained by other causes. C35016 Shock 2072 FDA C54450 FDA Patient Problem Code Hierarchy C35019 Shock, Surgical 2267 Surgical Shock Hypoperfusion of body tissues occurring during or after a surgical procedure, and resulting in cellular injury and vital organ dysfunction. C35016 Shock 2072 FDA C54450 FDA Patient Problem Code Hierarchy C50782 Shock, Traumatic 2268 Traumatic Shock Any shock produced by trauma. Any shock produced by trauma. C35016 Shock 2072 FDA C54450 FDA Patient Problem Code Hierarchy C50741 Sinus, Perforation Of 2277 Perforation Of Sinus A rupture in the sinus tissue due to traumatic or pathologic processes. C4080 Perforation 2001 FDA C54450 FDA Patient Problem Code Hierarchy C26883 Sjogren's Syndrome 2073 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 Autoimmune Disease 1732 FDA C54450 FDA Patient Problem Code Hierarchy C3327 Skin Discoloration 2074 Discoloration Of Skin Abnormal skin coloration. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50845 Skin Erosion 2075 Erosion, Skin A gradual breakdown or very shallow ulceration of the skin which involves only the epidermis and heals without scarring. Tearing or wearing off of skin. C50443 Erosion 1750 FDA C54450 FDA Patient Problem Code Hierarchy C2983 Skin Inflammation 2443 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50743 Skin Irritation 2076 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 Irritation 1941 FDA C54450 FDA Patient Problem Code Hierarchy C50744 Skin Tears 2516 A break in skin tissue caused by friction or shearing. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3376 Sleep Disturbances 2517 Disturbances, Sleep A change from the patient's baseline sleeping pattern, in the hours slept and/or an alteration/dysfunction in the stages of sleep. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50746 Sneezing 2251 A symptom consisting of the involuntary expulsion of air from the nose. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50747 Sore Throat 2396 Throat, Sore Any kind of inflammatory process of the tonsils, pharynx, or/and larynx characterized by pain in swallowing. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50750 Spinal Cord Injury 2432 Injury, Spinal Cord Traumatic damage of the spinal cord. C4974 Nervous System Injury 2689 FDA C54450 FDA Patient Problem Code Hierarchy C50751 Spinal Injury 2081 Injury, Spinal Damage to the spine that results in impaired function. C3671 Injury 2348 FDA C54450 FDA Patient Problem Code Hierarchy C35035 Sprain 2083 A stretching or tearing of a ligament. C3671 Injury 2348 FDA C54450 FDA Patient Problem Code Hierarchy C41330 ST Segment Depression 2487 Depression, ST Segment An electrocardiographic finding of ST segment depression below the baseline, often described as up sloping, down sloping or horizontal. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50540 ST Segment Elevation 2059 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50752 Stacking Breaths 1593 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50921 Staphylococcus Aureus 2058 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50754 Stenosis 2263 Stricture Narrowing or stricture of a duct or canal. Narrowing or stricture of a vessel, duct or canal. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50664 Stiffness, Neck 2434 Neck Stiffness Limited mobility of the neck, usually accompanied by pain. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50756 Strangulation 2084 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 Injury 2348 FDA C54450 FDA Patient Problem Code Hierarchy C50911 Sudden Cardiac Death 2510 Cardiac Death, Sudden|Death, Sudden Cardiac An unexpected natural death from a cardiac cause within a short time period from the onset of symptoms. C28554 Death 1802 FDA C54450 FDA Patient Problem Code Hierarchy C50762 Suffocation 2088 The stopping of respiration or the asphyxia that results from it. The stopping of respiration or the asphyxia that results from it. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50763 Sunset Syndrome 2089 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50868 Suture Abrasion 2497 Wearing away of the surface of a suture as a result of bending and frictional forces. C50449 Abrasion 1689 FDA C54450 FDA Patient Problem Code Hierarchy C36172 Sweating 2444 A watery secretion by the sweat glands that is primarily composed of salt, urea and minerals. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3399 Swelling 2091 Enlargement; expansion in size; sign of inflammation C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50764 Swollen Glands 2092 Glands, Swollen An enlarged lymph node. Causes include viral and bacterial infections and cancers that affect the lymph nodes. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50765 Swollen Lymph Nodes 2093 Lymph Nodes, Swollen|Nodes, Swollen Lymph The presence of an enlarged lymph node. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C35053 Syncope 1610 Faint A spontaneous loss of consciousness caused by insufficient blood supply to the brain. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50766 Synovitis 2094 Inflammation of a synovial membrane. Inflammation of a synovial membrane. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C38029 Tachycardia 2095 Heart Rate, Increased|Increased Heart Rate An abnormally rapid heart rate. Thresholds for different age, gender, and patient populations exist. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50552 Tearing, Excessive 2235 Excessive Tearing Profuse lacrimation. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50778 Teeth, Sensitivity Of 2427 Sensitivity Of Tooth Pain or discomfort caused by exposure of the dentin layer of tooth to thermal, tactile, or other stimuli. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50844 Tentorial Tears 2097 Tears, Tentorial Pertaining to tears involving the tentorium of the cerebellum. Pertaining to tears involving the tentorium of the cerebellum. C50440 Brain Injury 2219 FDA C54450 FDA Patient Problem Code Hierarchy C50916 Teratogenic Effects 2273 Effects, Teratogenic The result of processes that negatively affect a developing fetus. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C36292 Test Result 2695 The outcome of a laboratory test. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50789 Therapeutic Effects, Unexpected 2099 Effects, Unexpected Therapeutic|Unexpected Therapeutic Effects Unanticipated desirable and beneficial effects resulting from a medical treatment. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50526 Therapeutic Response, Decreased 2271 Decreased Therapeutic Response|Response, Decreased Therapeutic A reduction in the desirable and beneficial effects resulting from a medical treatment. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50611 Therapeutic Response, Increased 2272 Increased Therapeutic Response|Response, Increased Therapeutic An increase in the desirable and beneficial effects resulting from a medical treatment. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C76132 Third-Degree Burn 2696 A full thickness burn that extends into deeper tissues causing white or blackened and charred skin that may be numb. An injury that includes all skin layers into the subcutaneous tissue due to chemical, friction, radiation or thermal exposure. The affected area appears dry and thickened; damage to nerve endings usually renders the wound painless. C34441 Burn(s) 1757 FDA C54450 FDA Patient Problem Code Hierarchy C28195 Thromboembolism 2654 Occlusion of the lumen of a vessel by a thrombus that has migrated from a distal site via the blood stream. C26759 Embolism 1829 FDA C54450 FDA Patient Problem Code Hierarchy C26891 Thrombosis 2100 The formation of a blood clot in the lumen of a vessel or heart chamber; causes include coagulation disorders and vascular endothelial injury. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C27083 Thrombus 2101 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50770 Thyroid Problems 2102 Problems, Thyroid C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50771 Tingling 2171 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50772 Tinnitus 2103 Ears, Ringing In|Ringing In Ears A noise in the ears, such as ringing, buzzing, roaring, clicking. Abnormal perception of sounds experienced by an individual in the absence of auditory stimulation. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C61375 Tissue Breakdown 2681 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 Tissue Damage 2104 FDA C54450 FDA Patient Problem Code Hierarchy C50773 Tissue Damage 2104 Damage, Tissue C3671 Injury 2348 FDA C54450 FDA Patient Problem Code Hierarchy C50779 Torsades-de-Pointes 2107 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 electrocardiogram. C50802 Ventricular Tachycardia 2132 FDA C54450 FDA Patient Problem Code Hierarchy C50780 Toxemia 2207 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 Infection, Bacterial 1735 FDA C54450 FDA Patient Problem Code Hierarchy C35498 Toxic Shock Syndrome 2108 Shock Syndrome (TSS), Toxic|Syndrome (TSS), Toxic Shock|TSS, Toxic Shock Syndrome|Toxic Shock Syndrome, (TSS) A severe illness caused by infection with staphylococcus aureus and characterized by high fever of sudden onset, vomiting, diarrhea, and myalgia, followed by hypotension and in severe cases, shock; a sunburn-like rash with peeling of the skin, especially of the palms and soles, occurs during the acute phase. A rare acute life-threatening systemic bacterial noncontagious illness caused by any of several related staphylococcal exotoxins. It is 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 include leukocytosis, elevated prothrombin time, hypoalbuminemia, hypocalcemia, and pyuria. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C27990 Toxicity 2333 The finding of bodily harm due to the poisonous effects of something. C3671 Injury 2348 FDA C54450 FDA Patient Problem Code Hierarchy C50493 Toxins In Children 2098 Children, Toxins In Children affected by toxins may be due to silicone breast implants and their effects on unborn children and from breastfeeding. Children affected by toxins may be due to silicone breast implants and their effects on unborn children and from breastfeeding. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50454 Toxoplasmosis, Acquired 2269 Acquired Toxoplasmosis Acquired as an adult. Toxoplasmosis acquired in adulthood. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50503 Toxoplasmosis, Congenital 2270 Congenital Toxoplasmosis Passed from mother to fetus. Toxoplasma infection that is present from birth. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50781 Transient Ischemic Attack 2109 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50842 Tricuspid Insufficiency 2111 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 Insufficiency, Valvular 1926 FDA C54450 FDA Patient Problem Code Hierarchy C50843 Tricuspid Regurgitation 2112 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 Tricuspid Insufficiency 2111 FDA C54450 FDA Patient Problem Code Hierarchy C50783 Tricuspid Stenosis 2113 Stenosis, Tricuspid Narrowing or stricture of the tricuspid orifice of the heart. Narrowing or stricture of the tricuspid orifice of the heart. C62433 Valvular Stenosis 2697 FDA C54450 FDA Patient Problem Code Hierarchy C50784 Twiddlers Syndrome 2114 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50785 Twitching 2172 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50794 UGH (Uveitis-Glaucoma-Hyphema) Syndrome 2115 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3426 Ulcer 2274 A circumscribed inflammatory and often suppurating lesion on the skin or an internal mucous surface resulting in necrosis of tissue. C3671 Injury 2348 FDA C54450 FDA Patient Problem Code Hierarchy C25757 Ulceration 2116 The formation or development of an ulcer. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50428 Underdose 2542 An inadequate amount of a treatment. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C34851 Uremia 2188 A laboratory test result indicating abnormally high concentration of non-protein nitrogen in the blood. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C26906 Urinary Frequency 2275 Frequency, Urinary Urination at short intervals; it may result from increased urine formation, decreased bladder capacity, or lower urinary tract irritation. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50790 Urinary Retention 2119 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3432 Urticaria 2278 Hives Urticaria. A transient, itchy skin eruption characterized by wheals with pale interiors and red margins. C2983 Skin Inflammation 2443 FDA C54450 FDA Patient Problem Code Hierarchy C50793 Uterine Perforation 2121 Perforation Of Uterus A rupture in the uterus due to traumatic or pathologic processes. C4080 Perforation 2001 FDA C54450 FDA Patient Problem Code Hierarchy C26909 Uveitis 2122 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50795 Vaginal Discharge 2123 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50522 Vaginal Mucosa Damage 2124 Damage, Vaginal Mucosa|Mucosa Damage, Vaginal C3671 Injury 2348 FDA C54450 FDA Patient Problem Code Hierarchy C62433 Valvular Stenosis 2697 Narrowing of the opening of one or more of the four valves of the heart. C50754 Stenosis 2263 FDA C54450 FDA Patient Problem Code Hierarchy C50600 Vascular System (Circulation), Impaired 2572 Impaired Circulation C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C40866 Vasoconstriction 2126 Vasospasm Vasoconstriction involves narrowing of a blood vessel lumen due to smooth muscle contraction in the vessel wall and leads to decreased blood flow. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C40867 Vasodilatation 2127 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50798 Vaso-Vagal Response 2661 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3365 Venereal Disease 2071 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 Infection 1930 FDA C54450 FDA Patient Problem Code Hierarchy C28221 Venipuncture 2129 The collection of blood from a vein, most commonly via needle venipuncture. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50430 Ventilator Dependent 2395 Dependent, Ventilator C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50448 Ventricle, Abnormality Of 2078 C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50799 Ventricular Fibrillation 2130 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. A disorder characterized by 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) C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50800 Ventricular Flutter 2131 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 disorder characterized by an electrocardiographic finding of a high ventricular rate (180 to 250 beats per minute) with a regular rhythm and 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 Ventricular Tachycardia 2132 FDA C54450 FDA Patient Problem Code Hierarchy C50802 Ventricular Tachycardia 2132 An abnormally rapid ventricular rhythm with aberrant ventricular excitation, usually in excess of 150 beats per minute. A disorder characterized by 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) C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C38057 Vertigo 2134 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50647 Vessel Or Plaque, Device Embedded In 1204 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. Device and/or fragments of device are embedded in patient's vessel and/or plaque. C34620 Foreign Body In Patient 2687 FDA C54450 FDA Patient Problem Code Hierarchy C50804 Vessels, Perforation Of 2135 Perforation Of Vessel(s) Damage to a blood vessel resulting from a full thickness disruption in the integrity of the vessel wall. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C14283 Virus 2136 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50602 Vision, Impaired 2138 Impaired Vision Sight that is impaired. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50638 Vision, Loss Of 2139 Loss Of Vision A condition in which the ability to see is impaired. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50805 Visual Disturbances 2140 Disturbances, Visual An interference to normal eyesight. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50837 Vitrectomy 2643 Surgical removal of the vitreous humor from the chamber of the eye. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50808 Vitreous Floaters 1866 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50469 Vitreous Fluid, Blood In 2143 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50639 Vitreous Fluid, Loss Of 2142 Fluid, Loss Of Vitreous|Loss Of Vitreous Fluid C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50807 Vitreous, Detachment Of 2445 Detachment Of Vitreous Detachment of the vitreous humor from the retina. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50587 Vitritis 2181 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. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C3442 Vomiting 2144 Forceful ejection of the contents of the stomach through the mouth. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50809 Weakness 2145 The property of lacking physical strength. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50810 Weight Fluctuations 2607 Fluctuations Of Weight Repetitive loss and regain of body weight. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50811 Wheal(s) 2241 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 Irritation 1941 FDA C54450 FDA Patient Problem Code Hierarchy C50863 Wound Dehiscence 1154 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 Dehiscence Of Organ 2502 FDA C54450 FDA Patient Problem Code Hierarchy C50704 Wound Infection, Post-Operative 2446 Infection, Post-Operative Wound|Post-Operative Wound Infection Infection of a surgical skin incision. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50705 Wound Infection, Post-Traumatic 2447 Infection, Post-Traumatic Wound|Post-Traumatic Wound Infection Infection of a wound following trauma. C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C50435 Wrinkling 2613 C54450 FDA Patient Problem Code Hierarchy FDA C54450 FDA Patient Problem Code Hierarchy C72898 Zonular Dehiscence 2698 Rupture of the fibrous strands connecting the ciliary body and the crystalline lens of the eye. C50527 Dehiscence Of Organ 2502