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
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
Terminology that represents conclusions of an evaluation used by the CDRH with respect to reporting Medical Device events.
C62596
CDRH Terminology
Terminology that represents methods of evaluation used by the CDRH with respect to reporting Medical Device events.
C62596
CDRH Terminology
Terminology that represents results of evaluation used by the CDRH with respect to reporting Medical Device events.
C62596
CDRH Terminology
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
A device or material designed to take in or attenuate a force or substance.
C54577
FDA Device Component Code Hierarchy
A device or material designed to sequester carbon dioxide.
C50372
3028
Absorber
A device or material designed to collect a force or substance.
C54577
FDA Device Component Code Hierarchy
A device designed to automate an action.
C54577
FDA Device Component Code Hierarchy
A device designed to make different pieces of apparatus compatible.
C54577
FDA Device Component Code Hierarchy
Any substance that affixes 2 or more parts or tissues together.
C54577
FDA Device Component Code Hierarchy
A filtering device designed to remove particles from air.
C54577
FDA Device Component Code Hierarchy
A device designed to remove air from a space or fluid.
C54577
FDA Device Component Code Hierarchy
A composite part of an air pump or a larger device that includes an air pump.
C54577
FDA Device Component Code Hierarchy
A device designed to signal the occurrence of a particular event.
C54577
FDA Device Component Code Hierarchy
A composite part of an alarm or a larger device that includes an alarm.
C49813
403
Alarm
A device designed to signal the occurrence of a particular event by making a sound.
C49813
403
Alarm
A device designed to signal the occurrence of a high pressure event associated with a mechanical ventilation device.
C49816
412
Alarm, Pressure
A device designed to signal the occurrence of a particular event by activating a light emitting diode.
C49813
403
Alarm
A device designed to signal the occurrence of a low pressure event associated with a mechanical ventilation device.
C49816
412
Alarm, Pressure
A device designed to signal that an oxygen source pressure is outside of an established range.
C49816
412
Alarm, Pressure
A device designed to signal the occurrence of a power fluctuation beyond an established range.
C49813
403
Alarm
A device designed to signal the occurrence of a pressure fluctuation beyond an established range.
C49813
403
Alarm
C49813
403
Alarm
A device designed to signal the occurrence of a particular event in a way that can be seen.
C49813
403
Alarm
A device designed to signal that a gas volume level is outside of an established range.
C49813
403
Alarm
An electric generator designed to produce an alternating current.
C54577
FDA Device Component Code Hierarchy
A device designed to measure height above the ground.
C50052
462
Gauges/Meters
An electronic device designed to take an input signal and output an increased signal strength.
C54577
FDA Device Component Code Hierarchy
Any device designed to perform an analysis.
C54577
FDA Device Component Code Hierarchy
A device designed to indicate which electrical circuit is actively receiving current.
C54577
FDA Device Component Code Hierarchy
A device designed to transmit or receive electromagnetic signals.
C54577
FDA Device Component Code Hierarchy
A device designed to transfer a substance to a surface.
C54577
FDA Device Component Code Hierarchy
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
An electrical device designed to reduce the strength of a signal.
C54577
FDA Device Component Code Hierarchy
A system designed to pump a gas or liquid into a space or environment without outside intervention.
C50316
3076
Injection System
A rigid, removable sheet that covers the back of a device.
C54577
FDA Device Component Code Hierarchy
A circuit board with connectors into which other cards are plugged.
C54577
FDA Device Component Code Hierarchy
A filter designed to remove bacteria from a gas or liquid.
C49956
816
Filter
A plate or similar structure designed to direct the flow of a fluid or dissipate its energy.
C54577
FDA Device Component Code Hierarchy
A flexible container, often with a single opening.
C54577
FDA Device Component Code Hierarchy
Any device that is spherical in shape.
C54577
FDA Device Component Code Hierarchy
An electrical device designed to limit an electric current or to provide a starting voltage.
C54577
FDA Device Component Code Hierarchy
Any of various types of bags designed to be distended.
C54577
FDA Device Component Code Hierarchy
A structure or object that impedes free movement.
C54577
FDA Device Component Code Hierarchy
A device designed to produce an electric current through chemical reaction.
C54577
FDA Device Component Code Hierarchy
A device designed to restore the capacity of a battery.
C49868
426
Charger
An optical device designed to take an electromagnetic beam and separate it into two or more parts.
C54577
FDA Device Component Code Hierarchy
A point of contact between moving parts designed for support or to reduce friction.
C54577
FDA Device Component Code Hierarchy
Handle-like devices designed to facilitate a person's ability to get upright and out of a bed.
C54577
FDA Device Component Code Hierarchy
A device designed to make a ringing sound when struck.
C54577
FDA Device Component Code Hierarchy
A device consisting of a narrow loop of material moving over shafts or pulleys.
C54577
FDA Device Component Code Hierarchy
A device designed to produce a stream of air.
C54577
FDA Device Component Code Hierarchy
A device around which thread, tape, or other flexible material can be wound.
C54577
FDA Device Component Code Hierarchy
A device designed to measure heat radiation.
C50052
462
Gauges/Meters
A screw designed to thread into a nut to form a fastener.
C54577
FDA Device Component Code Hierarchy
A device designed to deliver a bolus into a system.
C50285
3085
Mechanism
A bracket designed for holding a bottom dead center sensor.
C54577
FDA Device Component Code Hierarchy
A device designed to slow or stop a moving part.
C54577
FDA Device Component Code Hierarchy
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
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
A device designed to signal the presence of bubbles in a system.
C49916
787
Detector
A set of electrical conductors designed to route data from multiple locations in a computer.
C54577
FDA Device Component Code Hierarchy
A cylindrical metal sleeve designed to reduce the friction of a rotating shaft.
C54577
FDA Device Component Code Hierarchy
An electronic signaling device designed to make a buzzing sound by vibration of an armature.
C54577
FDA Device Component Code Hierarchy
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
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
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
A small flexible tube inserted into a body cavity for draining off fluid or introducing medication.
C54577
FDA Device Component Code Hierarchy
A device designed to assist in the proper placement of a cannula.
C49974
829
Guide
The inner component of a double-cannula device, designed to be easily removable and replaceable.
C50343
3036
Cannula
The outer component of a double-cannula device, designed to be indwelling.
C50343
3036
Cannula
A top (as for a bottle).
C54577
FDA Device Component Code Hierarchy
An electrical device designed to store an electric charge.
C54577
FDA Device Component Code Hierarchy
A device designed to facilitate the support, movement, or transport of another device or object.
C54577
FDA Device Component Code Hierarchy
A collection of interconnected devices designed to act together to repeat and enhance a signal.
C54577
FDA Device Component Code Hierarchy
A container designed to hold film or magnetic tape.
C54577
FDA Device Component Code Hierarchy
A pivoting roller or wheel designed to attach to an object to make it movable.
C54577
FDA Device Component Code Hierarchy
A flexible tube designed to transfer fluids into or out of the body.
C54577
FDA Device Component Code Hierarchy
A device designed to coagulate and seal blood vessels or to destroy tissue with heat or electric current.
C54577
FDA Device Component Code Hierarchy
A device that is designed as a removable and replaceable part of another device.
C54577
FDA Device Component Code Hierarchy
A device designed to restore the capacity of a system.
C54577
FDA Device Component Code Hierarchy
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
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
A non-conducting board to which electronic components are attached.
C54577
FDA Device Component Code Hierarchy
A device designed to open an electrical circuit when it becomes overloaded.
C54577
FDA Device Component Code Hierarchy
A device designed to hold things firmly together.
C54577
FDA Device Component Code Hierarchy
A small device designed to hold and attach items together.
C54577
FDA Device Component Code Hierarchy
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
A device designed to sense the level of or warn of carbon dioxide in a space or environment.
C50074
886
Monitor
A carbon dioxide monitor assembly designed to be part of another device.
C54577
FDA Device Component Code Hierarchy
A device designed to generate a code.
C54577
FDA Device Component Code Hierarchy
A structure consisting of something wound in a continuous series of loops.
C54577
FDA Device Component Code Hierarchy
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
A device for comparing something with a similar thing or with a standard measure.
C54577
FDA Device Component Code Hierarchy
A pump designed to facilitate the movement or compression of air.
C50128
925
Pump
The physical components from which a computer is constructed (electronic circuits and input/output devices).
C54577
FDA Device Component Code Hierarchy
A reduced-volume form of the liquid that is used in a dialysis machine to carry away waste products.
C76185
3050
Device Ingredient Or Reagent
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
A coil consisting of a conducting material such as that in a solenoid.
C49877
761
Coil
A rod designed to transmit motion between moving parts.
C54577
FDA Device Component Code Hierarchy
Any device or coupling designed to serve as a link between devices.
C54577
FDA Device Component Code Hierarchy
A projecting part of a device that allows it to be secured through an opening.
C50101
906
Pin
A corrective, cosmetic, or therapeutic lens placed on the cornea of the eye.
C50030
866
Lenses
A switch designed to control or regulate the operation of a device.
C50199
519
Switches
A device designed to control or regulate the operation of another device.
C54577
FDA Device Component Code Hierarchy
A device designed to change a substance, form, or state into another.
C54577
FDA Device Component Code Hierarchy
Cooling System
A device designed to regulate and lower the temperature of a heat generating device or system.
C50311
3116
System
A flexible cable designed to connect electronic devices.
C54577
FDA Device Component Code Hierarchy
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
A device designed to keep track of the number of times something happens.
C54577
FDA Device Component Code Hierarchy
A weight designed to counteract the effects of another weight.
C54577
FDA Device Component Code Hierarchy
Any device designed to connect other objects.
C54577
FDA Device Component Code Hierarchy
An object designed to conceal, enclose, cap, or protect something.
C54577
FDA Device Component Code Hierarchy
The part of a computer which controls all the other parts. Designs vary widely but, in general, the CPU consists of the control unit, the arithmetic and logic unit (ALU) and memory (registers, cache, RAM and ROM) as well as various temporary buffers and other logic.
C61402
3041
Computer Hardware
The main circuit board housing the central processing unit.
C61402
3041
Computer Hardware
An extension to a shaft designed to impart a rotational energy to the shaft.
C54577
FDA Device Component Code Hierarchy
An evacuated glass tube designed to accelerate electrons onto a screen to create images.
C50236
525
Tube
A clear cover over an instrument or any crystalline element component of an electronic device.
C54577
FDA Device Component Code Hierarchy
A bandlike device or structure that encircles a body part or another device.
C54577
FDA Device Component Code Hierarchy
A circular seal with a depressed center and raised sealing lips. They are designed to contain high pressure in one direction but not the other.
C50163
432
Seal
Any part of a device that resembles a bowl-shaped container.
C54577
FDA Device Component Code Hierarchy
A device designed to maintain a current at a specified level regardless of other fluctuations in the system.
C54577
FDA Device Component Code Hierarchy
An electronic device designed to generate a constant current.
C54577
FDA Device Component Code Hierarchy
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
A device designed to slice or sever a material.
C54577
FDA Device Component Code Hierarchy
A cable designed to drive the rotational cutter of a catheter device.
C49855
423
Cable
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
A valve designed to regulate the flow from a storage cylinder.
C50243
527
Valve
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
A device designed to automatically receive and store data and format it for later use.
C50329
3127
Unit
A device designed to convert a coded signal or message to an uncoded version.
C54577
FDA Device Component Code Hierarchy
The part of a defibrillator designed to be placed in contact with the body.
C54577
FDA Device Component Code Hierarchy
An electronic device designed to deliver a controlled electric shock to the heart in order to restore a normal heart rhythm, as a part of a larger device.
C53996
3051
Device Subassembly
A device designed to remove moisture from the air.
C54577
FDA Device Component Code Hierarchy
A device designed to remove moisture from a substance or material.
C54577
FDA Device Component Code Hierarchy
A device designed to remove ions from a substance or environment.
C54577
FDA Device Component Code Hierarchy
A communication or electronic circuit designed to delay the transmission of a signal by a set amount.
C54577
FDA Device Component Code Hierarchy
A device designed to remove the magnetic properties of an object or material.
C54577
FDA Device Component Code Hierarchy
A device designed to isolate a data signal from a carrier wave.
C54577
FDA Device Component Code Hierarchy
A device designed to measure density.
C50052
462
Gauges/Meters
A device designed to signal the presence of a specific condition.
C54577
FDA Device Component Code Hierarchy
A device designed to install something or distribute something in a systematic way.
C54577
FDA Device Component Code Hierarchy
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
A largely self-contained device designed to be incorporated into a larger device.
C54577
FDA Device Component Code Hierarchy
Either a circular indicator or a control knob on a device.
C54577
FDA Device Component Code Hierarchy
A device consisting of a flexible sheet or partition.
C54577
FDA Device Component Code Hierarchy
A device designed to convert analog signal to digital signal.
C54577
FDA Device Component Code Hierarchy
An electronic component designed to pass current in one direction only.
C54577
FDA Device Component Code Hierarchy
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
Any device component shaped like a disk, especially those used for data storage.
C54577
FDA Device Component Code Hierarchy
A device designed to present information visually.
C54577
FDA Device Component Code Hierarchy
C54577
FDA Device Component Code Hierarchy
A device component designed with a hemispherical shape.
C54577
FDA Device Component Code Hierarchy
An amplifier that doubles the voltage or frequency of an input signal.
C54577
FDA Device Component Code Hierarchy
A computer interface designed to control the interaction between a CPU and a peripheral device.
C54577
FDA Device Component Code Hierarchy
A device structure designed to channel the movement of gas or liquid.
C54577
FDA Device Component Code Hierarchy
A simple electronic device used for testing purposes designed to draw the same current as a complex device.
C54577
FDA Device Component Code Hierarchy
An electronic switching device that allows an antenna to be used for both transmitting and receiving.
C54577
FDA Device Component Code Hierarchy
A device designed to give a continuous reading of the electrical currents of the heart.
C50074
886
Monitor
An electronic device designed to record the electric currents of a beating heart, as part of a larger device.
C53996
3051
Device Subassembly
C50282
3079
Lead
A wire designed for electrical transmission of signal or power.
C50269
430
Wire
A conductor that is designed to make contact with part of a circuit or system.
C54577
FDA Device Component Code Hierarchy
A connector on a device designed to couple with an electrode.
C54577
FDA Device Component Code Hierarchy
A button and circuits designed to force the shutdown of a machine or device.
C54577
FDA Device Component Code Hierarchy
A mechanism designed to quickly halt the movement of a feed table.
C54577
FDA Device Component Code Hierarchy
The electron source electrode in a transistor or any source in a system.
C54577
FDA Device Component Code Hierarchy
A structure designed to house a device.
C54577
FDA Device Component Code Hierarchy
A device designed to covert a signal or message to a coded version.
C54577
FDA Device Component Code Hierarchy
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
A supplementary device or component designed to work with an endoscope.
C54577
FDA Device Component Code Hierarchy
A type of read only memory device that can be written to after manufacture, erased, and reused.
C50050
503
PROM (Programmable Read Only Memory)
An electronic device designed to alter the frequency of a signal, usually to adjust for distortion.
C54577
FDA Device Component Code Hierarchy
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
A filter designed to remove something from the expiration stream of a ventilator.
C49956
816
Filter
A device designed to stretch or enlarge a structure.
C54577
FDA Device Component Code Hierarchy
A device designed to lengthen a structure.
C54577
FDA Device Component Code Hierarchy
A fiberoptic device designed to remain outside of the body.
C50358
3059
Fiberoptic
A device designed to remove or separate a material or object from some other material or object.
C54577
FDA Device Component Code Hierarchy
A device designed to create a hole in an object for the passage of a cord.
C54577
FDA Device Component Code Hierarchy
A device designed to prevent malfunction, unsafe, or unauthorized operation of a device or system.
C50311
3116
System
A device designed to create an air current through the rotation of a planar surface.
C54577
FDA Device Component Code Hierarchy
A device designed to hold something in place.
C54577
FDA Device Component Code Hierarchy
A device designed to allow a connection to pass through a structural component of a device.
C54577
FDA Device Component Code Hierarchy
A metal cap designed to strengthen the end of an implement.
C54577
FDA Device Component Code Hierarchy
A transistor designed so that current through it is controlled by a variable electric field.
C54577
FDA Device Component Code Hierarchy
Any device made from a long, slender material.
C54577
FDA Device Component Code Hierarchy
A device designed to assist in installation of fiberoptic cables.
C49974
829
Guide
A device made with thin fibers of glass or plastic as a conduit for the transmission of light.
C54577
FDA Device Component Code Hierarchy
A material designed to form an outer protective surface on an optical fiber.
C50358
3059
Fiberoptic
A device designed for cutting an optical fiber and processing the ends for attachment.
C50358
3059
Fiberoptic
A photographic material designed to capture an image upon exposure to electromagnetic radiation.
C54577
FDA Device Component Code Hierarchy
A device to hold an amount of film and facilitate its loading into a device.
C49955
815
Film
A device designed to chemically treat film to develop the images on it.
C50122
919
Processor
A device designed to remove something from whatever passes through it.
C54577
FDA Device Component Code Hierarchy
A protruding edge designed to strengthen or stabilize a device or facilitate its attachment to a surface.
C54577
FDA Device Component Code Hierarchy
An electric device designed to repeatedly and rapidly turn a light on and off.
C54577
FDA Device Component Code Hierarchy
A device designed to measure the flow rate of a fluid.
C50052
462
Gauges/Meters
A thin, flexible sheet of metal.
C54577
FDA Device Component Code Hierarchy
A lever designed to be operated with the foot.
C54577
FDA Device Component Code Hierarchy
A switch designed to be actuated by foot pressure.
C50199
519
Switches
A structure designed to support or contain an object.
C54577
FDA Device Component Code Hierarchy
A device designed to monitor a specific function of a system.
C50001
844
Indicator
A lighted component that is part of a function indicator.
C50002
460
Function Indicator
C54577
FDA Device Component Code Hierarchy
An enclosed chamber designed to produce heat.
C54577
FDA Device Component Code Hierarchy
An electrical device designed to stop the flow of current when an overload condition exists.
C54577
FDA Device Component Code Hierarchy
A system designed to supply a gas flow to another device or system.
C50311
3116
System
A device designed to remove certain gases from a gas stream or environment.
C54577
FDA Device Component Code Hierarchy
A preformed material designed to form a seal between connecting surfaces.
C54577
FDA Device Component Code Hierarchy
Meter
A device designed to give a visual indication of the condition of a system.
C54577
FDA Device Component Code Hierarchy
Gear
A toothed wheel designed to mesh with another toothed object and transmit motion.
C54577
FDA Device Component Code Hierarchy
An engine designed to produce electricity or a device designed to produce a vapor or gas.
C54577
FDA Device Component Code Hierarchy
A framework of bars designed as a covering or divider.
C54577
FDA Device Component Code Hierarchy
A ring-like device designed for lining a round opening for reinforcement or protection.
C54577
FDA Device Component Code Hierarchy
A wire cable or strap designed to carry current safely away from an electronic device.
C54577
FDA Device Component Code Hierarchy
A device designed to help direct the passage of another object.
C54577
FDA Device Component Code Hierarchy
A flexible wire designed to help position medical devices within the body.
C50269
430
Wire
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
A part of a mechanical device designed to be used while held in the hand.
C54577
FDA Device Component Code Hierarchy
A part of a device designed to stabilize or support the hand.
C54577
FDA Device Component Code Hierarchy
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
A device designed to give physical feedback in a remote control system.
C54577
FDA Device Component Code Hierarchy
A pipe containing multiple feeder pipes, especially the exhaust pipe that connects to each cylinder of an engine.
C54577
FDA Device Component Code Hierarchy
A device with sound speakers designed to be worn on the head in proximity to the ears.
C54577
FDA Device Component Code Hierarchy
A projection on the end of an object
C54577
FDA Device Component Code Hierarchy
An accessory for a telephone that is worn on the head and designed to allow hands free conversation.
C54577
FDA Device Component Code Hierarchy
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
A mechanical heart valve where the valve mechanisms consists of two thin blades that hinge from the center and regulate the flow of blood.
C50283
3081
Leaflet
A ring of supportive material around a heart valve designed to provide a stable surface for attachment to surrounding tissues.
C50148
943
Ring
A device designed to transfer heat between fluids across a barrier or to the environment.
C54577
FDA Device Component Code Hierarchy
A thermally conductive structure designed to carry heat away from an electronic device.
C54577
FDA Device Component Code Hierarchy
A device designed to generate heat.
C54577
FDA Device Component Code Hierarchy
The rod-like part of certain heaters from which the radiant energy is released.
C54577
FDA Device Component Code Hierarchy
A coil designed to allow a Helifix pacing electrode to be placed in the endocardium.
C49877
761
Coil
A device component of a catheter assembly designed to prevent backflow of blood and thus minimize inadvertent blood loss while accessing the vasculature.
C50243
527
Valve
A seal designed to be airtight.
C50163
432
Seal
A device designed to join two objects and allow them to swing relative to one another.
C54577
FDA Device Component Code Hierarchy
A device designed to hold another object.
C54577
FDA Device Component Code Hierarchy
Any device made from a fiber with a hollow center, particularly those for cell propagation in culture.
C49952
814
Fiber
A flexible tube designed to carry a fluid.
C54577
FDA Device Component Code Hierarchy
A flexible tube designed to carry a fluid.
C54577
FDA Device Component Code Hierarchy
A structural enclosure designed to contain or support a device.
C54577
FDA Device Component Code Hierarchy
An electronic device designed as a central connection for other devices.
C54577
FDA Device Component Code Hierarchy
A device designed to add moisture to the air.
C54577
FDA Device Component Code Hierarchy
An electronic device containing circuits of different technological types.
C54577
FDA Device Component Code Hierarchy
A bed that includes a hydraulic system designed for movement or positioning of an object or subject.
C50311
3116
System
A system designed to use fluid pressure to bring about movement.
C50311
3116
System
A device that uses only integrated circuits.
C54577
FDA Device Component Code Hierarchy
A microelectronic device that incorporates many interconnected transistors and components.
C54577
FDA Device Component Code Hierarchy
A device designed to light a fire.
C54577
FDA Device Component Code Hierarchy
A device designed to create or record a visual representation of something.
C54577
FDA Device Component Code Hierarchy
A device designed to change the resistance of an electric circuit.
C54577
FDA Device Component Code Hierarchy
A device designed to create an electronic index of information.
C54577
FDA Device Component Code Hierarchy
A device designed to show an operating condition of a system or to attract attention.
C54577
FDA Device Component Code Hierarchy
A device designed to introduce electromotive force to a circuit, usually a coil surrounding a wire.
C54577
FDA Device Component Code Hierarchy
Injector System
A system designed to pump a gas or liquid into a space or environment.
C50311
3116
System
A material designed to reduce the transmission of heat, sound, or electricity.
C54577
FDA Device Component Code Hierarchy
C54577
FDA Device Component Code Hierarchy
A communications device designed for use between rooms of a building.
C54577
FDA Device Component Code Hierarchy
C54577
FDA Device Component Code Hierarchy
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
A device designed to stop the flow of current in a circuit.
C54577
FDA Device Component Code Hierarchy
A structural device designed to hang an intravenous solution bag.
C54577
FDA Device Component Code Hierarchy
An electrical device that converts direct current to alternating current.
C54577
FDA Device Component Code Hierarchy
A corrective lens that is designed to be implanted within the eye capsule to replace the natural lens.
C50030
866
Lenses
Any material or structure designed to limit the interaction between two components.
C54577
FDA Device Component Code Hierarchy
A tool designed to lift an object.
C54577
FDA Device Component Code Hierarchy
A device designed to use opposing parts to close on and hold an object.
C54577
FDA Device Component Code Hierarchy
A device designed as the junction between objects; it may be flexible or rigid.
C54577
FDA Device Component Code Hierarchy
A control device that uses a movable handle to create two-axis input for a computer device.
C54577
FDA Device Component Code Hierarchy
A small connector designed to make temporary connections in electrical circuits.
C54577
FDA Device Component Code Hierarchy
A device designed to join two or more things.
C54577
FDA Device Component Code Hierarchy
A device consisting of mechanical keys that are pressed to create input to a computer.
C54577
FDA Device Component Code Hierarchy
A device designed for signaling by hand using one or more switches.
C54577
FDA Device Component Code Hierarchy
A device consisting of keys, usually in a block arrangement, that provides limited input to a system.
C54577
FDA Device Component Code Hierarchy
A collection of objects or devices collected together for a particular function or purpose.
C54577
FDA Device Component Code Hierarchy
A cutting device usually consisting of a sharpened blade attached to a handle.
C54577
FDA Device Component Code Hierarchy
A handle, usually attached to a shaft allowing manual rotation of the shaft.
C54577
FDA Device Component Code Hierarchy
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
A material consisting of multiple layers bonded together.
C54577
FDA Device Component Code Hierarchy
A device designed to produce light or heat.
C54577
FDA Device Component Code Hierarchy
A device designed to emit a monochromatic beam of coherent light.
C54577
FDA Device Component Code Hierarchy
A device through which a laser beam emerges.
C50291
3092
Nozzle
A fastening device for a swinging part usually consisting of a bar that is retained in a slot.
C54577
FDA Device Component Code Hierarchy
An insulated electrical conductor designed to connect to an electrical device.
C54577
FDA Device Component Code Hierarchy
A bundle of leads designed to connect between a pacing device and implanted heart electrodes.
C54577
FDA Device Component Code Hierarchy
A device designed to form the end of an electrical lead.
C50324
3123
Tip
Any device that resembles a small leaf, especially one that has two thin blades hinged in the center.
C54577
FDA Device Component Code Hierarchy
A disk-shaped valve component of a tilting disk mechanical heart valve.
C50283
3081
Leaflet
A type of diode designed to emit light when a current passes through it.
C49922
447
Diode
An electric or optical device designed to focus electromagnetic radiation.
C54577
FDA Device Component Code Hierarchy
A switch designed to cut off power automatically to a moving object when it reaches a predetermined point.
C50199
519
Switches
An electronic device designed to prevent the amplitude of a wave from exceeding a set limit.
C54577
FDA Device Component Code Hierarchy
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
A battery consisting of a lithium anode and a cathode of iodine and poly-2-vinyl pyridine. They are especially useful in devices like pacemakers because of their long life.
C49839
420
Battery
Any device that draws current from an electrical system.
C54577
FDA Device Component Code Hierarchy
A fastening device designed to hold, close, or secure.
C54577
FDA Device Component Code Hierarchy
A fastening device designed to hold, close, or secure.
C50285
3085
Mechanism
A cylindrical fitting that slides over a part and locks into place.
C54577
FDA Device Component Code Hierarchy
A device designed to prevent multiple, simultaneous connections to a system.
C50285
3085
Mechanism
The circuit board that contains most of the processor units.
C54577
FDA Device Component Code Hierarchy
A bearing located toward the bottom of a piston.
C49842
734
Bearings
A valve that incorporates a Luer fitting.
C50243
527
Valve
A compartment in a device designed to house a consumable material for feeding into a mechanism.
C54577
FDA Device Component Code Hierarchy
A device that attracts iron and produces a magnetic field.
C54577
FDA Device Component Code Hierarchy
A device designed to make another object magnetic.
C54577
FDA Device Component Code Hierarchy
A device designed to measure the strength of a magnetic field.
C50052
462
Gauges/Meters
A variable resistor that can be controlled by a magnetic field.
C54577
FDA Device Component Code Hierarchy
An optical device designed to enlarge an image.
C54577
FDA Device Component Code Hierarchy
A branched system of pipes, typically those that attach to an engine to carry away exhaust.
C54577
FDA Device Component Code Hierarchy
C54577
FDA Device Component Code Hierarchy
A device consisting of moving parts designed to perform a function.
C54577
FDA Device Component Code Hierarchy
A device that is made from or resembles a thin flexible sheet of material.
C54577
FDA Device Component Code Hierarchy
Any device that can hold data in machine-readable format.
C54577
FDA Device Component Code Hierarchy
A needle-shaped part designed to indicate a position on a scale.
C50290
3088
Needle
An integrated circuit containing multiple components.
C54577
FDA Device Component Code Hierarchy
A device designed to convert sound to an electrical signal.
C54577
FDA Device Component Code Hierarchy
An optical instrument that uses a combination of lenses to produce magnified images of very small objects
C54577
FDA Device Component Code Hierarchy
A device consisting of a polished surface designed to reflect light.
C54577
FDA Device Component Code Hierarchy
A mechanical device designed to blend materials or an electronic device designed to blend signals.
C54577
FDA Device Component Code Hierarchy
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
An electronic device designed to vary the frequency, amplitude, or phase of an electromagnetic signal.
C54577
FDA Device Component Code Hierarchy
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
The circuit board that contains most of the processor units.
C54577
FDA Device Component Code Hierarchy
A device designed to signal the presence of excess motion in a system.
C49916
787
Detector
A device designed to convert energy into mechanical motion.
C54577
FDA Device Component Code Hierarchy
A device consisting of a motor and accessory parts designed to power a machine.
C50329
3127
Unit
A pin that is formed as a rolled sheet and acts to provide a retaining force on the part through which it is inserted.
C50101
906
Pin
A structural device designed to facilitate the attachment of one object to another.
C54577
FDA Device Component Code Hierarchy
A device designed to take an input and increase some characteristic of it.
C54577
FDA Device Component Code Hierarchy
A device designed to convert a liquid to a mist.
C54577
FDA Device Component Code Hierarchy
A device part with a long, slender, pointed shape.
C54577
FDA Device Component Code Hierarchy
A collection of two or more computers and associated devices that are linked together with communications equipment.
C54577
FDA Device Component Code Hierarchy
An indication that there is no device or component that matches the criteria.
C54577
FDA Device Component Code Hierarchy
A device designed to regulate and direct the flow of a fluid.
C54577
FDA Device Component Code Hierarchy
A device designed to form the end of a nozzle.
C50324
3123
Tip
A threaded fastener designed to engage a bolt.
C54577
FDA Device Component Code Hierarchy
A sensor and circuit designed to sense the oxygen level in a space, environment, or material, as part of a larger device.
C53996
3051
Device Subassembly
A sensor designed to respond to the presence or level of oxygen in a space or environment.
C50166
510
Sensor
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
A valve designed to allow flow in only one direction.
C50243
527
Valve
A cable designed to use fiberoptic strands to transmit signals.
C49855
423
Cable
A data storage disk where the data is stored in a format to be read optically by a laser and receiver.
C49925
791
Disk
A device made with thin glass fibers as a conduit for transmission of light.
C49952
814
Fiber
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
An electronic device designed to produce a wave signal.
C54577
FDA Device Component Code Hierarchy
An electronic device designed to display electrical measurements, typically as a waveform on a cathode ray tube.
C54577
FDA Device Component Code Hierarchy
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
An enclosed structural device designed for heating an object.
C54577
FDA Device Component Code Hierarchy
A device designed to be applied over an object, typically for protection or identification.
C54577
FDA Device Component Code Hierarchy
Oximeter
A device designed to measure oxygen saturation in arterial blood.
C50052
462
Gauges/Meters
A device designed to measure the concentration of oxygen in a gas mixture.
C54577
FDA Device Component Code Hierarchy
A protective or cushioning material applied to a projecting or supporting surface of a device.
C54577
FDA Device Component Code Hierarchy
A device resembling a bed.
C54577
FDA Device Component Code Hierarchy
A rigid sheet that forms a surface of a device or component.
C54577
FDA Device Component Code Hierarchy
A circuit board that has connections that are preapplied, usually added using photo-resist and acid etching techniques.
C54577
FDA Device Component Code Hierarchy
A device designed to detect light.
C49916
787
Detector
An electronic sensing device designed to amplify low-energy light signals and convert them to electrical pulses.
C54577
FDA Device Component Code Hierarchy
An electronic device designed to detect and amplify light signals.
C50236
525
Tube
A transistor in which incident light acts as the base activating input.
C54577
FDA Device Component Code Hierarchy
An electromagnetic device designed to convert movement to an electric signal.
C54577
FDA Device Component Code Hierarchy
A two-way valve designed to control the pressure in an endotracheal tube cuff as introduced through a pilot balloon.
C50243
527
Valve
A small, slender object designed to secure another object.
C54577
FDA Device Component Code Hierarchy
A measuring device, traditionally including a graduated tube, designed for the accurate transfer of liquid volumes.
C54577
FDA Device Component Code Hierarchy
A device similar to a bushing but designed to reduce the linear friction between a piston and its cylinder.
C49974
829
Guide
The portion of a piston above the topmost seal ring.
C49980
832
Heads
A pad designed to fit onto the head of a piston.
C54577
FDA Device Component Code Hierarchy
A device designed to act as a center of rotation.
C54577
FDA Device Component Code Hierarchy
A sheet of metal or wood or glass or plastic.
C54577
FDA Device Component Code Hierarchy
A computer driven instrument designed for drawing graphs and pictures.
C54577
FDA Device Component Code Hierarchy
A device designed to seat into an opening in a device.
C54577
FDA Device Component Code Hierarchy
A mechanical device designed to slide within a chamber to transfer a material.
C54577
FDA Device Component Code Hierarchy
An indicator device designed to show a position on a scale.
C54577
FDA Device Component Code Hierarchy
An optical device that creates polarized light from incident light.
C54577
FDA Device Component Code Hierarchy
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
A structural device part that supports or aligns other parts.
C54577
FDA Device Component Code Hierarchy
A device designed to measure a direct current electromotive force or a device designed to control the current that flows through a circuit.
C50052
462
Gauges/Meters
A flexible cable designed to connect an electric device to a power source.
C49890
768
Cord
A light designed to indicate the status of a power source or power connection.
C54577
FDA Device Component Code Hierarchy
An independent electronic device designed to supply power to other devices.
C54577
FDA Device Component Code Hierarchy
Any electronic device designed to supply power to other devices.
C54577
FDA Device Component Code Hierarchy
A switch designed to regulate the power to a device.
C50199
519
Switches
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
An electronic counter device designed to reduce a very high frequency signal to a lower frequency by division.
C54577
FDA Device Component Code Hierarchy
A preamplifier device that is designed to operate between an antenna and a receiver to improve reception.
C54577
FDA Device Component Code Hierarchy
A sensor designed to respond to the level of pressure in a space or pressing on a surface.
C50166
510
Sensor
A device designed to monitor or display a pressure reading.
C54577
FDA Device Component Code Hierarchy
Flexible tubing designed to withstand high pressure.
C50236
525
Tube
An electronic device that is designed to transfer text or images to paper or other substrate.
C54577
FDA Device Component Code Hierarchy
A device designed to reach into a location for manipulating or sensing.
C54577
FDA Device Component Code Hierarchy
A probe device designed to convert a change in pressure into a varying electrical signal.
C50121
918
Probe
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
A device designed to write instructions to a memory device.
C54577
FDA Device Component Code Hierarchy
A type of read only memory device that can be written to once after manufacture.
C50048
509
ROM (Read Only Memory)
Any pointed projection on a device, usually one designed to attach a device to something else.
C54577
FDA Device Component Code Hierarchy
A device or attachment designed to shield something from harm.
C54577
FDA Device Component Code Hierarchy
A switch designed to actuate when something comes within a predetermined distance.
C50199
519
Switches
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
A device designed to produce a short burst of signal.
C54577
FDA Device Component Code Hierarchy
A device designed to facilitate the movement of a fluid.
C54577
FDA Device Component Code Hierarchy
A device designed to advance something by pushing it.
C54577
FDA Device Component Code Hierarchy
A device designed to measure high temperatures, such as those in a furnace.
C50052
462
Gauges/Meters
A bar designed for support, attachment, guidance, or protection from falling.
C54577
FDA Device Component Code Hierarchy
A data storage device for which the order of access to different locations does not affect the speed of access. RAM can be both read from and written to by the computer, but its contents are lost when the power is switched off.
C50047
877
Memory
A sensor for a pacemaker designed to alter the rate of heart stimulation based on the activity level of the subject.
C50166
510
Sensor
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
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
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
As part of a cochlear implant, an implanted device designed to receive signal from the external device and then decode the signal and transmit it to the brain.
C50329
3127
Unit
A device designed to capture and store audiovisual or other data.
C54577
FDA Device Component Code Hierarchy
An electrical device designed to convert alternating current to direct current.
C54577
FDA Device Component Code Hierarchy
A switch device consisting of thin, flexible, magnetically controlled contacts enclosed in a sealed and evacuated enclosure.
C54577
FDA Device Component Code Hierarchy
Any device designed to control a process or condition.
C54577
FDA Device Component Code Hierarchy
An electrical circuit designed to act as a switch for another circuit.
C54577
FDA Device Component Code Hierarchy
An electronic device designed to receive a signal, amplify it, and resend it.
C54577
FDA Device Component Code Hierarchy
A vessel designed to store a fluid.
C54577
FDA Device Component Code Hierarchy
An electronic device that opposes the flow of current.
C54577
FDA Device Component Code Hierarchy
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
A physical device designed to hold something in place.
C54577
FDA Device Component Code Hierarchy
A pin designed to fasten one object into another.
C50101
906
Pin
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
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
Any device that consists of a long, narrow, flexible material.
C54577
FDA Device Component Code Hierarchy
Any doughnut-shaped device.
C54577
FDA Device Component Code Hierarchy
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
A mechanical device designed to perform an automated action.
C54577
FDA Device Component Code Hierarchy
Any rod-shaped device.
C54577
FDA Device Component Code Hierarchy
A type of data storage device which is manufactured with fixed contents. ROM is inherently non-volatile storage, retaining its contents even when the power is switched off.
C50047
877
Memory
A mechanical or electronic device designed to prevent one action from happening when certain conditions exist.
C54577
FDA Device Component Code Hierarchy
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
A device designed for weighing or an indicator device with a graduated sequence of divisions.
C54577
FDA Device Component Code Hierarchy
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
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
A device designed to measure radioactivity indirectly by its ability to cause flashes of light in a sensitive material.
C50052
462
Gauges/Meters
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
An electronic device designed as a display or a physical device designed to be a protective meshwork.
C54577
FDA Device Component Code Hierarchy
A fastener device with a tapered threaded shaft and a head designed to engage a drive device.
C54577
FDA Device Component Code Hierarchy
The end of a screw designed to interact with a drive device.
C49980
832
Heads
A device designed to cut threads in a object
C54577
FDA Device Component Code Hierarchy
A pointed device designed to etch a mark on an object.
C54577
FDA Device Component Code Hierarchy
A device designed to prevent passage of some material through a joint or opening.
C54577
FDA Device Component Code Hierarchy
A device component of an endotracheal tube (ET) assembly designed to provide a tight fit for the ET tube to the tracheal wall and thus an effective seal between the device and the tissue.
C50163
432
Seal
A filter designed to remove particles from a liquid.
C49956
816
Filter
A device designed to respond to a stimulus by generating a signal that can be measured or interpreted.
C50121
918
Probe
An electronic device designed to amplify the force of a movement.
C54577
FDA Device Component Code Hierarchy
A long rod.
C54577
FDA Device Component Code Hierarchy
A device designed to form a protective covering or structure.
C54577
FDA Device Component Code Hierarchy
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
A mechanical device designed to change the gears in a mechanism.
C54577
FDA Device Component Code Hierarchy
The component of a defibrillator designed to store the electrical charge before it is delivered to the patient.
C49862
555
Capacitor
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
An implantable device designed to drain fluid from a body cavity.
C54577
FDA Device Component Code Hierarchy
A mechanical or electronic device designed to regulate an exposure time, especially the one in a camera.
C54577
FDA Device Component Code Hierarchy
A supportive or protective rail attached to the side of something.
C50130
927
Rail
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
A device designed to create a test or training environment that approximates actual conditions.
C54577
FDA Device Component Code Hierarchy
A flat rectangular piece of glass on which specimens can be mounted for microscopic study.
C54577
FDA Device Component Code Hierarchy
A ring-shaped electrical contact designed to provide connection to a rotating part.
C50148
943
Ring
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
A device designed as an opening into which something else fits.
C54577
FDA Device Component Code Hierarchy
A device designed to allow an incompatible plug to connect with another device.
C49808
431
Adapter (Adaptor)
A connection between objects formed by solder.
C54577
FDA Device Component Code Hierarchy
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
A device or material designed to attenuate sound energy.
C50372
3028
Absorber
A device designed to position objects further apart.
C54577
FDA Device Component Code Hierarchy
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
A device designed to convert electrical signals to sounds that can be heard.
C54577
FDA Device Component Code Hierarchy
A device designed to measure wave lengths and angles of deflection of an electromagnetic radiation source, generating a spectrum plot across frequencies.
C50052
462
Gauges/Meters
An electronic device designed to convert speech sounds into electrical signals, especially as part of a cochlear implant.
C54577
FDA Device Component Code Hierarchy
A device designed to measure lung capacity.
C50052
462
Gauges/Meters
A device designed to join pieces of a material into a continuous length.
C54577
FDA Device Component Code Hierarchy
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
An elastic device designed to bend under a load and then return to its shape when unloaded.
C54577
FDA Device Component Code Hierarchy
A device that uses a spring to deliver something into a device or system.
C50285
3085
Mechanism
A device designed to reduce unwanted movement.
C54577
FDA Device Component Code Hierarchy
A support device designed to hold an object.
C54577
FDA Device Component Code Hierarchy
A fastening device consisting of a bent wire designed to pierce and hold.
C54577
FDA Device Component Code Hierarchy
A wire designed to connect to a steering device.
C50269
430
Wire
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
A motor designed to rotate in fixed increments.
C50077
486
Motor
A material or device designed to stiffen an object.
C54577
FDA Device Component Code Hierarchy
A rotating device designed to act like a faucet for regulating the flow of a fluid.
C54577
FDA Device Component Code Hierarchy
A rotating valve designed to regulate the flow of a fluid through a stopcock.
C50243
527
Valve
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
A conductor cable designed as a thin, flexible ribbon of metals separated by an insulating layer.
C54577
FDA Device Component Code Hierarchy
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
C54577
FDA Device Component Code Hierarchy
A lamp designed to emit ultraviolet radiation.
C54577
FDA Device Component Code Hierarchy
An electrical device designed to reduce or eliminate unwanted currents.
C54577
FDA Device Component Code Hierarchy
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
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
A switch designed to be operated by pressing a button.
C50199
519
Switches
A mechanical or electronic device designed to break or change the connections in a circuit.
C54577
FDA Device Component Code Hierarchy
A mechanical device on a transmission designed to make the gears spin at the same speed.
C54577
FDA Device Component Code Hierarchy
C54577
FDA Device Component Code Hierarchy
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
A device designed to advance a syringe plunger at a specified rate, used to administer continuous subcutaneous infusions.
C54577
FDA Device Component Code Hierarchy
A group of independent but interrelated devices working together.
C54577
FDA Device Component Code Hierarchy
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
The uppermost, flat surface of a table.
C54577
FDA Device Component Code Hierarchy
A device designed to measure a speed of rotation.
C50052
462
Gauges/Meters
A long, thin, flat, flexible material often used for measuring, binding or fastening, or as a recording medium.
C54577
FDA Device Component Code Hierarchy
A device designed to be used for transesophogeal echocardiogram (TEE).
C54577
FDA Device Component Code Hierarchy
Equipment designed to transmit and receive data from a remote source using telecommunications methods.
C54577
FDA Device Component Code Hierarchy
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
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
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
An electrical device designed to receive a television signal and display an image.
C50329
3127
Unit
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
A remote sensor designed to respond to the temperature of a space, surface, or environment.
C50121
918
Probe
A sensor designed to respond to the temperature of a space, surface, or environment.
C50166
510
Sensor
An electronic device designed to provide access to a computer.
C54577
FDA Device Component Code Hierarchy
A part of a device that includes a terminal as part of a larger device.
C54577
FDA Device Component Code Hierarchy
A device designed to connect to the end of a bus network.
C54577
FDA Device Component Code Hierarchy
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
A type of resistor designed from materials whose resistance varies as a function of temperature.
C54577
FDA Device Component Code Hierarchy
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
A wire designed for temperature acquisition as part of a thermocouple.
C50269
430
Wire
A device designed to measure temperature.
C50052
462
Gauges/Meters
A device designed to regulate temperature by controlling the starting and stopping of a heating/cooling system.
C54577
FDA Device Component Code Hierarchy
A fine cord typically used for sewing.
C54577
FDA Device Component Code Hierarchy
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
A device designed to measure a time interval.
C54577
FDA Device Component Code Hierarchy
The extreme end of something, especially something pointed.
C54577
FDA Device Component Code Hierarchy
A coil associated with a tip conductor voltage tester.
C49877
761
Coil
The part of a tomography machine on which the subject lays.
C50293
3095
Pallet
A device, usually for connecting tubing, that resembles the letter T.
C49885
435
Connector
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
An electronic device designed to be both a transmitter and a receiver.
C54577
FDA Device Component Code Hierarchy
An electrical device that converts one form of energy into another.
C54577
FDA Device Component Code Hierarchy
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
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
A device designed to convert computer code or signals from one type to another.
C54577
FDA Device Component Code Hierarchy
A conductor designed to transfer power or signal from one location to another.
C54577
FDA Device Component Code Hierarchy
A device to propagate electromagnetic waves.
C54577
FDA Device Component Code Hierarchy
An electrical device designed to send a specific response upon receiving a specific signal.
C54577
FDA Device Component Code Hierarchy
Any device designed to move something.
C54577
FDA Device Component Code Hierarchy
Three Terminal Current Controlling Semiconductor
A bidirectional thyristor designed to control AC power.
C54577
FDA Device Component Code Hierarchy
A capacitor having variable capacitance or a device designed to cut something to size.
C54577
FDA Device Component Code Hierarchy
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
Any device or component shaped like a hollow cylinder.
C54577
FDA Device Component Code Hierarchy
A tube with a narrow diameter designed to hold a liquid by capillary action.
C50236
525
Tube
An electronic receiver designed to capture signals of a selected frequency for amplification.
C54577
FDA Device Component Code Hierarchy
A largely self-contained device designed to be incorporated into a larger device.
C54577
FDA Device Component Code Hierarchy
A computer program that controls the interaction between a user and a system.
C50008
848
Interface
Valve (One-Way, Hemo, Stopcock, Etc.)
A mechanical device designed to control the flow of a fluid.
C54577
FDA Device Component Code Hierarchy
A rotating disk attached to a shaft designed to control the opening and closing of a valve.
C54577
FDA Device Component Code Hierarchy
A valve designed to regulate the flow of a fluid, especially one designed to operate in response to a signal from a control system.
C50243
527
Valve
A valve designed to control the flow of fluid in a hydraulic system.
C50243
527
Valve
A outflow valve designed to quickly empty a system.
C50243
527
Valve
A valve designed to allow the escape of exhaled gases from a respirator or respiration system.
C50243
527
Valve
A valve that is hinged on one edge.
C50243
527
Valve
A valve designed to regulate the flow of fluid, especially one designed to prevent flow when a certain flow rate is exceeded.
C50243
527
Valve
A valve designed to regulate the flow of gases into a respirator or respiration system.
C50243
527
Valve
A valve that controls the flow of fluids in through the wall of a chamber.
C50243
527
Valve
A valve designed to regulate the flow of gases into a respirator or respiration system.
C50243
527
Valve
A valve designed to control the flow of fluids out through the wall of a chamber.
C50243
527
Valve
A valve designed to work on a positive airway pressure device to maintain the positive pressure at the end of the respiratory cycle.
C50243
527
Valve
A valve designed to automatically open in order to maintain the pressure in a system below a specified pressure.
C50243
527
Valve
A valve designed to automatically open in order to maintain the pressure in a system below a specified pressure.
C50243
527
Valve
A valve designed to automatically open in order to maintain the pressure in a system below a specified pressure.
C50243
527
Valve
A valve designed to control which of several ports will be connected to a system.
C50243
527
Valve
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
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
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
A mechanical device designed to create a vibratory motion.
C54577
FDA Device Component Code Hierarchy
C54577
FDA Device Component Code Hierarchy
A device designed to measure the voltage potential difference between points in a circuit.
C50052
462
Gauges/Meters
A device designed to cleanse an object, or a flattened disk used as a mechanical seal between objects.
C54577
FDA Device Component Code Hierarchy
A system designed to remove unwanted substances from water.
C50311
3116
System
A material and device designed to guide and shape an electromagnetic wave.
C49974
829
Guide
A filter designed so that its thickness or transmission properties increase from one edge to another.
C49956
816
Filter
Any joining connection that is the result of welding 2 or more parts.
C54577
FDA Device Component Code Hierarchy
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
A tire designed to be mounted on a wheelchair wheel.
C54577
FDA Device Component Code Hierarchy
A wheel designed to be used on a wheelchair.
C51067
3130
Wheel
A transparent panel in a device designed for visual inspection.
C54577
FDA Device Component Code Hierarchy
A metal strand designed for signal or power transmission or for structural or other purpose.
C54577
FDA Device Component Code Hierarchy
A collection of grouped wires or cables designed to connect to a specific device.
C54577
FDA Device Component Code Hierarchy
A structural device designed to connect multiple objects.
C54577
FDA Device Component Code Hierarchy
A device, usually for connecting tubing, that resembles the letter Y.
C49885
435
Connector
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
2892
Charging Problem
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
2897
Component or Accessory Incompatibility
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
4042
Activation Problem
IMDRF:A1501
Problem associated with the activation of the device.
Problem associated with the activation of a device.
C63013
2906
Activation, Positioning or Separation Problem
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
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
IMDRF:A160101
The device does not display an alarm message when required.
A device does not display an alarm message when required.
C63033
1012
Device Alarm System
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
2929
Environmental Compatibility Problem
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
2929
Environmental Compatibility Problem
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
1112
Computer Software Problem
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
2880
Application Program Problem
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
1112
Computer Software Problem
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
2880
Application Program Problem
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
2880
Application Program Problem
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
2880
Application Program Problem
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
2880
Application Program Problem
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
2880
Application Program Problem
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
2899
Computer System Security Problem
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
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
1198
Electrical /Electronic Property Problem
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
2583
Arcing
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
2583
Arcing
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
3005
Output Problem
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
2954
Improper Flow or Infusion
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
1198
Electrical /Electronic Property Problem
IMDRF:A070501
Problem related to increased battery internal impedance.
Problem related to increased battery internal impedance.
C63030
2885
Battery Problem
IMDRF:A070502
Problem related to decreased battery internal impedance.
Problem related to decreased battery internal impedance.
C63030
2885
Battery Problem
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
2682
Patient-Device Incompatibility
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
1120
Contamination During Use
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
2900
Connection Problem
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
2978
Material Integrity Problem
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
2978
Material Integrity Problem
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
1153
Degraded
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
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
1089
Circuit Failure
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
1198
Electrical /Electronic Property Problem
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
1198
Electrical /Electronic Property Problem
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
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
1198
Electrical /Electronic Property Problem
IMDRF:A030201
Clumping
Problem associated with the aggregation of particles into irregular masses.
Problem associated with the aggregation of particles into irregular masses.
C62982
2910
Device Ingredient or Reagent Problem
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
2910
Device Ingredient or Reagent Problem
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
2506
Structural Problem
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
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
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
2423
Obstruction of Flow
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
3010
Power Problem
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
2897
Component or Accessory Incompatibility
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
2912
Device Misassembled During Manufacturing / Shipping
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
2912
Device Misassembled During Manufacturing / Shipping
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
2960
Compatibility Problem
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
1112
Computer Software Problem
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
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
1112
Computer Software Problem
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
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
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
2895
Contamination / decontamination Problem
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
1120
Contamination During Use
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
1198
Electrical /Electronic Property Problem
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
1153
Degraded
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
2978
Material Integrity Problem
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
2910
Device Ingredient or Reagent Problem
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
1112
Computer Software Problem
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
1112
Computer Software Problem
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
1112
Computer Software Problem
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
2900
Connection Problem
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
3012
Pressure Problem
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
2170
Suction Problem
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
3016
Pumping Problem
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
2917
Device Sensing Problem
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
1012
Device Alarm System
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
2975
Manufacturing, Packaging or Shipping Problem
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
2975
Manufacturing, Packaging or Shipping Problem
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
1198
Electrical /Electronic Property Problem
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
2964
Infusion or Flow Problem
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
2976
Material Deformation
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
2978
Material Integrity Problem
IMDRF:A160104
Alarm, Delayed
The device alarm system operates with delay.
A device alarm system operates with delay.
C63033
1012
Device Alarm System
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
2892
Charging Problem
IMDRF:A110301
Problem associated with delayed execution relating to program or algorithm.
Problem associated with a delayed execution relating to program or algorithm.
C133593
4033
Program or Algorithm Execution Problem
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
1570
Shipping Damage or Problem
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
2976
Material Deformation
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
1384
Mechanical Problem
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
3015
Protective Measures Problem
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
2682
Patient-Device Incompatibility
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
2895
Contamination / decontamination Problem
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
1120
Contamination During Use
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
1120
Contamination During Use
IMDRF:A0502
Problem associated with one device causing harm to another device.
Problem associated with one device causing harm to another device.
C62961
1384
Mechanical Problem
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
2975
Manufacturing, Packaging or Shipping Problem
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
2949
Human-Device Interface Problem
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
2949
Human-Device Interface Problem
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
2949
Human-Device Interface Problem
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
3026
Unintended Movement
IMDRF:A090201
Problem associated with providing incorrect display information.
Problem associated with providing incorrect display information.
C63088
1184
Display or Visual Feedback Problem
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
2893
Chemical Problem
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
3026
Unintended Movement
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
1670
Use of Device Problem
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
2893
Chemical Problem
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
1318
Labelling, Instructions for Use or Training Problem
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
2975
Manufacturing, Packaging or Shipping Problem
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
2939
Failure to Shut Off
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
2895
Contamination / decontamination Problem
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
1198
Electrical /Electronic Property Problem
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
3026
Unintended Movement
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
3026
Unintended Movement
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
2929
Environmental Compatibility Problem
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
2960
Compatibility Problem
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
4042
Activation Problem
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
3009
Positioning Problem
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
4043
Separation Problem
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
3009
Positioning Problem
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
2964
Infusion or Flow Problem
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
2506
Structural Problem
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
3009
Positioning Problem
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
4017
Interrogation Problem
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
2506
Structural Problem
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
3007
Packaging Problem
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
3009
Positioning Problem
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
2900
Connection Problem
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
1184
Display or Visual Feedback Problem
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
3005
Output Problem
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
1506
Product Quality Problem
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
1384
Mechanical Problem
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
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
1198
Electrical /Electronic Property Problem
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
2929
Environmental Compatibility Problem
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
1089
Circuit Failure
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
1198
Electrical /Electronic Property Problem
IMDRF:A072001
Problem associated with a measure of electromagnetic radiation from equipment.
Problem associated with a measure of electromagnetic radiation from equipment.
C63215
2927
Electromagnetic Compatibility Problem
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
1198
Electrical /Electronic Property Problem
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
2925
Electrical Power Problem
IMDRF:A0904
Problem with the device's intended output of energy.
Problem with the device's intended output of energy.
C62941
3005
Output Problem
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
1431
Energy Output Problem
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
3009
Positioning Problem
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
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
2929
Environmental Compatibility Problem
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
1184
Display or Visual Feedback Problem
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
2964
Infusion or Flow Problem
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
3022
Temperature Problem
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
3022
Temperature Problem
IMDRF:A210101
Problem associated with errors in identification of expiration date.
Problem associated with errors in identification of expiration date.
C62976
2911
Device Markings / Labelling Problem
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
2978
Material Integrity Problem
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
1395
Migration or Expulsion of Device
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
2936
Fail-Safe Problem
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
3015
Protective Measures Problem
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
3015
Protective Measures Problem
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
3009
Positioning Problem
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
2984
Mechanics Altered
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
2917
Device Sensing Problem
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
3015
Protective Measures Problem
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
2902
Data Back-Up Problem
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
2890
Calibration Problem
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
2891
Capturing Problem
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
2892
Charging Problem
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
1091
Device Reprocessing Problem
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
1198
Electrical /Electronic Property Problem
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
1439
Pacing Problem
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
2902
Data Back-Up Problem
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
2984
Mechanics Altered
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
2984
Mechanics Altered
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
2991
No Flow
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
1431
Energy Output Problem
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
1573
Defibrillation Problem
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
1198
Electrical /Electronic Property Problem
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
2900
Connection Problem
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
1091
Device Reprocessing Problem
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
4009
Ejection Problem
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
4011
Firing Problem
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
2976
Material Deformation
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
2984
Mechanics Altered
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
2991
No Flow
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
4017
Interrogation Problem
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
1535
Incorrect, Inadequate or Imprecise Result or Readings
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
3003
Osseointegration Problem
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
3010
Power Problem
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
4040
Priming Problem
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
3016
Pumping Problem
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
2896
Communication or Transmission Problem
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
2890
Calibration Problem
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
3019
Reset Problem
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
2885
Battery Problem
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
2917
Device Sensing Problem
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
2917
Device Sensing Problem
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
1198
Electrical /Electronic Property Problem
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
2896
Communication or Transmission Problem
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
2976
Material Deformation
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
3019
Reset Problem
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
1012
Device Alarm System
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
1535
Incorrect, Inadequate or Imprecise Result or Readings
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
1535
Incorrect, Inadequate or Imprecise Result or Readings
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
2964
Infusion or Flow Problem
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
2964
Infusion or Flow Problem
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
3022
Temperature Problem
IMDRF:A0505
Problem associated with the device not discharging as intended.
Problem associated with the device not discharging as intended.
C62961
1384
Mechanical Problem
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
2900
Connection Problem
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
1153
Degraded
IMDRF:A1008
Problem associated with device-related burn with an unsteady flame.
Problem associated with the device-related burn with an unsteady flame.
C62922
3022
Temperature Problem
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
1354
Leak / Splash
IMDRF:A180303
Flush, Failure To
Flushing process was not executed properly.
Flushing process was not executed properly.
C63099
1091
Device Reprocessing Problem
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
3027
Ventilation Problem in Device Environment
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
1069
Break
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
2954
Improper Flow or Infusion
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
2929
Environmental Compatibility Problem
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
2929
Environmental Compatibility Problem
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
1354
Leak / Splash
IMDRF:A0906
Gas Output, Improper
Problem associated with gas output.
Problem associated with gas output.
C62941
3005
Output Problem
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
1354
Leak / Splash
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
2954
Improper Flow or Infusion
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
1198
Electrical /Electronic Property Problem
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
2891
Capturing Problem
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
2950
Impedance Problem
IMDRF:A030206
pH, High
pH higher than expected and / or anticipated.
pH higher than expected and/or anticipated.
C62982
2910
Device Ingredient or Reagent Problem
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
1535
Incorrect, Inadequate or Imprecise Result or Readings
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
2917
Device Sensing Problem
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
1535
Incorrect, Inadequate or Imprecise Result or Readings
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
IMDRF:A210102
Problem associated with information unable to be read or deciphered.
Problem associated with information unable to be read or deciphered.
C62976
2911
Device Markings / Labelling Problem
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
1184
Display or Visual Feedback Problem
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
1184
Display or Visual Feedback Problem
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
1198
Electrical /Electronic Property Problem
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
2890
Calibration Problem
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
2893
Chemical Problem
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
2964
Infusion or Flow Problem
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
1670
Use of Device Problem
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
1233
Filling Problem
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
2991
No Flow
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
2954
Improper Flow or Infusion
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
2954
Improper Flow or Infusion
IMDRF:A210103
Problem associated with imprecise, inexact information.
Problem associated with imprecise, inexact information.
C62976
2911
Device Markings / Labelling Problem
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
1439
Pacing Problem
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
2682
Patient-Device Incompatibility
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
2941
Filtration Problem
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
1318
Labelling, Instructions for Use or Training Problem
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
1318
Labelling, Instructions for Use or Training Problem
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
1318
Labelling, Instructions for Use or Training Problem
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
2941
Filtration Problem
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
2949
Human-Device Interface Problem
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
4020
Audible Prompt / Feedback
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
3019
Reset Problem
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
1573
Defibrillation Problem
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
4022
Tactile Prompts / Feedback
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
1439
Pacing Problem
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
4020
Audible Prompt / Feedback
IMDRF:A051105
Problem associated with the heart valve leaflet not closing properly.
Problem associated with the heart valve leaflet not closing properly.
C62923
2506
Structural Problem
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
2900
Connection Problem
IMDRF:A141402
Problem associated with not adequately preparing the device.
Problem associated with not adequately preparing the device.
C133629
4040
Priming Problem
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
3007
Packaging Problem
IMDRF:A070912
Rhythm, Incorrect Interpretation Of
Problem with the device inappropriately analyzing a signal.
Problem with the device inappropriately analyzing a signal.
C63238
2917
Device Sensing Problem
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
1535
Incorrect, Inadequate or Imprecise Result or Readings
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
3005
Output Problem
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
3012
Pressure Problem
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
2170
Suction Problem
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
3016
Pumping Problem
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
2917
Device Sensing Problem
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
2964
Infusion or Flow Problem
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
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
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
3022
Temperature Problem
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
2964
Infusion or Flow Problem
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
3022
Temperature Problem
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
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
2891
Capturing Problem
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
2896
Communication or Transmission Problem
IMDRF:A072103
Continuity, Intermittent
Problem associated with intermittent faults in electrical/electronic interconnections.
Problem associated with intermittent faults in electrical/electronic interconnections.
C63277
1089
Circuit Failure
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
1431
Energy Output Problem
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
2954
Improper Flow or Infusion
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
3010
Power Problem
IMDRF:A110302
Problem associated with intermittent execution relating to program or algorithm.
Problem associated with intermittent execution relating to program or algorithm.
C133593
4033
Program or Algorithm Execution Problem
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
1573
Defibrillation Problem
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
1198
Electrical /Electronic Property Problem
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
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
1318
Labelling, Instructions for Use or Training Problem
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
1384
Mechanical Problem
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
2900
Connection Problem
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
4001
Patient Device Interaction Problem
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
3196
Data Problem
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
1069
Break
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
3003
Osseointegration Problem
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
2925
Electrical Power Problem
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
2917
Device Sensing Problem
IMDRF:A160103
Alarm, Low Audible
The audible device alarm cannot be heard clearly.
The audible device alarm cannot be heard clearly.
C63033
1012
Device Alarm System
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
2950
Impedance Problem
IMDRF:A030207
pH lower than expected and / or anticipated.
pH lower than expected and / or anticipated.
C62982
2910
Device Ingredient or Reagent Problem
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
1535
Incorrect, Inadequate or Imprecise Result or Readings
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
2917
Device Sensing Problem
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
1535
Incorrect, Inadequate or Imprecise Result or Readings
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
3009
Positioning Problem
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
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
2978
Material Integrity Problem
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
2978
Material Integrity Problem
IMDRF:A0408
Disintegrate
Problem associated with material breaking into small particles.
Problem associated with material breaking into small pieces.
C62968
2978
Material Integrity Problem
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
1153
Degraded
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
1069
Break
IMDRF:A040605
Frayed
Problem associated with the comprising materials having damaged edges.
Problem associated with the comprising materials having damaged edges.
C63248
2976
Material Deformation
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
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
2976
Material Deformation
IMDRF:A0409
Opacification
Opaque
Problem associated with an undesirable opaqueness or cloudiness.
Problem associated with an undesirable opaqueness or cloudiness.
C62968
2978
Material Integrity Problem
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
2978
Material Integrity Problem
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
2978
Material Integrity Problem
IMDRF:A041001
Puncture
Device material(s) punctured leading to undesired holes/openings.
Device material(s) punctured leading to undesired holes/openings.
C62967
2205
Material Perforation
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
2978
Material Integrity Problem
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
2978
Material Integrity Problem
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
2978
Material Integrity Problem
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
2976
Material Deformation
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
2976
Material Deformation
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
2976
Material Deformation
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
2960
Compatibility Problem
IMDRF:A0506
The motion of the device is prevented or restricted.
The motion of the device is prevented or restricted.
C62961
1384
Mechanical Problem
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
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
1384
Mechanical Problem
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
2929
Environmental Compatibility Problem
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
2976
Material Deformation
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
1120
Contamination During Use
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
1395
Migration or Expulsion of Device
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
4001
Patient Device Interaction Problem
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
1670
Use of Device Problem
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
2965
Installation-Related Problem
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
1398
Misassembled
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
1398
Misassembled
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
2900
Connection Problem
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
4011
Firing Problem
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
3001
Optical Problem
IMDRF:A210105
Absence of information e.g. labeling, instruction for use.
Absence of information e.g. labeling, instruction for use.
C62976
2911
Device Markings / Labelling Problem
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
1535
Incorrect, Inadequate or Imprecise Result or Readings
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
2986
Moisture or Humidity Problem
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
2929
Environmental Compatibility Problem
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
1153
Degraded
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
IMDRF:A160102
Alarm, Not Audible
The device fails to emit an audible alarm.
The device fails to emit an audible alarm.
C63033
1012
Device Alarm System
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
4020
Audible Prompt / Feedback
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
3005
Output Problem
IMDRF:A090206
Display, Failure To
Problem associated with the absence of display or image.
Problem associated with the absence of display or image.
C63088
1184
Display or Visual Feedback Problem
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
2936
Fail-Safe Problem
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
2964
Infusion or Flow Problem
IMDRF:A071204
Problem associated with the device ceasing to deliver paces.
Problem associated with the device ceasing to deliver paces.
C63169
1439
Pacing Problem
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
3012
Pressure Problem
IMDRF:A090302
Problem associated with the device ceasing to provide tactile feedback.
Problem associated with the device ceasing to provide tactile feedback.
C133547
4022
Tactile Prompts / Feedback
IMDRF:A090207
Problem associated with the device ceasing to provide visual feedback.
Problem associated with the device ceasing to provide visual feedback.
C63088
1184
Display or Visual Feedback Problem
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
1384
Mechanical Problem
IMDRF:A090806
Device results cannot be reliably reproduced.
Device results that cannot be reliably reproduced.
C62848
1535
Incorrect, Inadequate or Imprecise Result or Readings
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
1506
Product Quality Problem
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
2964
Infusion or Flow Problem
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
1670
Use of Device Problem
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
2898
Computer Operating System Problem
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
2898
Computer Operating System Problem
IMDRF:A0602
Lens, Decentration Of
Problem associated with being off-center of optical lenses.
Problem associated with being off-center of optical lenses.
C62953
3001
Optical Problem
IMDRF:A0603
Problem associated with an undesired change of color.
Problem associated with an undesired change of color.
C62953
3001
Optical Problem
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
3001
Optical Problem
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
3001
Optical Problem
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
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
4001
Patient Device Interaction Problem
IMDRF:A090404
Device output is exceeding the documented specifications of the device.
Device output is exceeding the documented specifications of the device.
C63002
1431
Energy Output Problem
IMDRF:A090405
Device output is below the documented specifications of the device.
Device output is below the documented specifications of the device.
C63002
1431
Energy Output Problem
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
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
2890
Calibration Problem
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
1233
Filling Problem
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
3022
Temperature Problem
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
2917
Device Sensing Problem
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
1439
Pacing Problem
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
1439
Pacing Problem
IMDRF:A071207
Pacing voltage or pulse width is less than desired.
Pacing voltage or pulse width is less than desired.
C63169
1439
Pacing Problem
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
1439
Pacing Problem
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
1198
Electrical /Electronic Property Problem
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
2975
Manufacturing, Packaging or Shipping Problem
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
2423
Obstruction of Flow
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
2910
Device Ingredient or Reagent Problem
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
3196
Data Problem
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
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
4001
Patient Device Interaction Problem
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
1153
Degraded
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
1354
Leak / Splash
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
1384
Mechanical Problem
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
1153
Degraded
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
1439
Pacing Problem
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
1184
Display or Visual Feedback Problem
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
3009
Positioning Problem
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
2906
Activation, Positioning or Separation Problem
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
2925
Electrical Power Problem
IMDRF:A0708
Problem associated with the energy to operate the device.
Problem associated with the energy to operate the device.
C63007
1198
Electrical /Electronic Property Problem
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
2910
Device Ingredient or Reagent Problem
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
4042
Activation Problem
IMDRF:A070504
Battery, Premature Discharge Of
Battery discharging earlier than expected.
Battery discharging earlier than expected.
C63030
2885
Battery Problem
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
3011
Premature Indicator Activation
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
3011
Premature Indicator Activation
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
3015
Protective Measures Problem
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
4043
Separation Problem
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
2964
Infusion or Flow Problem
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
2964
Infusion or Flow Problem
IMDRF:A180304
Enzymatic Cleaner, Failure To Remove
Enzymatic cleaner was not removed properly.
Enzymatic cleaner was not removed properly from the device.
C63099
1091
Device Reprocessing Problem
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
2880
Application Program Problem
IMDRF:A180305
Sterilization Failure
Sterilization, Inadequate
Device was not sterilized properly during reprocessing.
Device was not sterilized properly during reprocessing.
C63099
1091
Device Reprocessing Problem
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
2975
Manufacturing, Packaging or Shipping Problem
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
4033
Program or Algorithm Execution Problem
IMDRF:A1103
Problem associated with execution problems relating to program or algorithm.
Problem associated with execution problems relating to program or algorithm.
C63269
1112
Computer Software Problem
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
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
2964
Infusion or Flow Problem
IMDRF:A141204
Pumping, Stopped
Unexpected /unintended cessation of pump.
Unexpected /unintended cessation of pump.
C62860
3016
Pumping Problem
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
1354
Leak / Splash
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
4026
Radiation Output Problem
IMDRF:A0905
Problem with the device's intended output of radiation.
Problem with the device's intended output of radiation.
C62941
3005
Output Problem
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
4026
Radiation Output Problem
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
4026
Radiation Output Problem
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
2927
Electromagnetic Compatibility Problem
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
2954
Improper Flow or Infusion
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
3015
Protective Measures Problem
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
1091
Device Reprocessing Problem
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
2954
Improper Flow or Infusion
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
1384
Mechanical Problem
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
2978
Material Integrity Problem
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
4042
Activation Problem
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
2917
Device Sensing Problem
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
4043
Separation Problem
IMDRF:A1503
Problem associated with the detachment or separation of the device.
Problem associated with the detachment or separation of device.
C63013
2906
Activation, Positioning or Separation Problem
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
2506
Structural Problem
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
3015
Protective Measures Problem
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
2975
Manufacturing, Packaging or Shipping Problem
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
1233
Filling Problem
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
1535
Incorrect, Inadequate or Imprecise Result or Readings
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
3022
Temperature Problem
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
1069
Break
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
1198
Electrical /Electronic Property Problem
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
2976
Material Deformation
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
1384
Mechanical Problem
IMDRF:A141303
Problem associated with the complete inability to provide suction.
Problem associated with the complete inability to provide suction.
C62833
2170
Suction Problem
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
2964
Infusion or Flow Problem
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
3005
Output Problem
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
3007
Packaging Problem
IMDRF:A1304
Problem associated with variability of the transmission of telemetry signals.
Problem associated with variability of the transmission of telemetry signals.
C63271
2896
Communication or Transmission Problem
IMDRF:A10
Problem associated with the device producing unintended temperatures.
Problem associated with the device producing unintended temperatures.
C54451
FDA Device Problem Code Hierarchy
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
1431
Energy Output Problem
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
1431
Energy Output Problem
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
3022
Temperature Problem
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
2954
Improper Flow or Infusion
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
1535
Incorrect, Inadequate or Imprecise Result or Readings
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
2899
Computer System Security Problem
IMDRF:A210104
Problem associated with ambiguous, confused information.
Problem associated with ambiguous, confusing information.
C62976
2911
Device Markings / Labelling Problem
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
2917
Device Sensing Problem
IMDRF:A0719
Problem associated with the device unexpectedly powering down.
Problem associated with the device unexpectedly powering down.
C63007
1198
Electrical /Electronic Property Problem
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
3005
Output Problem
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
4026
Radiation Output Problem
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
2880
Application Program Problem
IMDRF:A051205
Collision, Unintended
Problem associated with the device impacting with another object.
Problem associated with the device impacting with another object.
C62814
3026
Unintended Movement
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
2960
Compatibility Problem
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
4009
Ejection Problem
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
1198
Electrical /Electronic Property Problem
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
1384
Mechanical Problem
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
3010
Power Problem
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
3026
Unintended Movement
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
1153
Degraded
IMDRF:A020503
Packaging, Unsealed
Problem associated with the loss of packaging seal.
Problem associated with the device's loss of packaging seal.
C62939
3007
Packaging Problem
IMDRF:A051207
Problem associated with the mechanical stability of the device.
Problem associated with the mechanical stability of a device.
C62814
3026
Unintended Movement
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
2891
Capturing Problem
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
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
1670
Use of Device Problem
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
2929
Environmental Compatibility Problem
IMDRF:A051208
Problem associated with the undesirable mechanical oscillation.
Problem associated with the undesirable mechanical oscillation in a device.
C62814
3026
Unintended Movement
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
1184
Display or Visual Feedback Problem
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
1233
Filling Problem
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
2896
Communication or Transmission Problem
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
4310
Cause Cannot be Traced to Device
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
4310
Cause Cannot be Traced to Device
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
4310
Cause Cannot be Traced to Device
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
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
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
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
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
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
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
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
19
Cause Traced to User
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
Problems traced to improper routine or preventative maintenance.
Problems traced to improper routine or preventative maintenance.
C91802
FDA Manufacturer Evaluation Conclusion Code Hierarchy
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
Problems caused by inadequate training.
Problems caused by inadequate training.
C91802
FDA Manufacturer Evaluation Conclusion Code Hierarchy
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
C91802
FDA Manufacturer Evaluation Conclusion Code Hierarchy
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
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
12
Cause Traced to Device Design
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
12
Cause Traced to Device Design
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
19
Cause Traced to User
Problems traced to the user not following the manufacturer's instructions.
Problems traced to the user not following the manufacturer's instructions.
C91874
19
Cause Traced to User
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
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
12
Cause Traced to Device Design
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
12
Cause Traced to Device Design
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
12
Cause Traced to Device Design
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
Problems traced to manufacturing process.
Problems traced to manufacturing process.
C91885
25
Cause Traced to Manufacturing
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
12
Cause Traced to Device Design
The device complaint or problem cannot be confirmed.
The device complaint or problem cannot be confirmed.
C91802
FDA Manufacturer Evaluation Conclusion Code Hierarchy
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
25
Cause Traced to Manufacturing
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
19
Cause Traced to User
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
19
Cause Traced to User
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
19
Cause Traced to User
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
19
Cause Traced to User
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
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
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
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
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
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
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
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
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
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
C91800
FDA Manufacturer Evaluation Method Code Hierarchy
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
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
C91800
FDA Manufacturer Evaluation Method Code Hierarchy
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
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
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
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
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
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
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
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
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
3255
Hematological Problem Identified
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
3228
Protective System Problem Identified
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
331
Environment Problem Identified
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
Problems that occurred because the device was assembled incorrectly.
Problems that occurred because the device was assembled incorrectly.
C92076
170
Manufacturing Process Problem Identified
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
3204
Biological Problem Identified
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
3204
Biological Problem Identified
C91801
FDA Manufacturer Evaluation Result Code Hierarchy
The device's ability to trigger development of cancer.
The device's ability to trigger development of cancer.
C92057
3254
Genotoxicity Problem Identified
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
4233
Patient Sample Problem
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
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
3213
Interoperability Problem Identified
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
3255
Hematological Problem Identified
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
197
Electromagnetic Compatibility Problem Identified
Problems due to change control or incorrect version, including regional requirements.
Problems due to change control or incorrect version, including regional requirements.
C92113
104
Software Problem Identified
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
331
Environment Problem Identified
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
120
Electrical Problem Identified
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
3204
Biological Problem Identified
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
110
Design Error
Storage of data was unsuccessful in total or in part.
Storage of data was unsuccessful in total or in part.
C92113
104
Software Problem Identified
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
3243
Stress Problem Identified
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
174
Material and/or Chemical Problem Identified
The device had faulty (incomplete or incorrect) software design.
The device had faulty (incomplete or incorrect) software design.
C92113
104
Software Problem Identified
Device problems including set-up, operation, and disassembly of equipment.
Device problems including set-up, operation, and disassembly of equipment.
C92088
114
Operational Problem Identified
Incorrect assembly of the device following reprocessing.
Incorrect assembly of the device following reprocessing.
C139575
4228
Device Incorrectly Reprocessed
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
4228
Device Incorrectly Reprocessed
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
4228
Device Incorrectly Reprocessed
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
114
Operational Problem Identified
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
180
Mechanical Problem Identified
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
3213
Interoperability Problem Identified
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
331
Environment Problem Identified
Device-to-device or device-environment problem resulting from electromagnetic disturbances.
C91801
FDA Manufacturer Evaluation Result Code Hierarchy
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
120
Electrical Problem Identified
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
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
197
Electromagnetic Compatibility Problem Identified
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
142
Biological Contamination
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
3227
Power Source Problem Identified
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
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
331
Environment Problem Identified
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
331
Environment Problem Identified
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
331
Environment Problem Identified
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
104
Software Problem Identified
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
642
Thermal Problem
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
642
Thermal Problem
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
3228
Protective System Problem Identified
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
114
Operational Problem Identified
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
3243
Stress Problem Identified
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
3243
Stress Problem Identified
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
180
Mechanical Problem Identified
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
3204
Biological Problem Identified
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
3230
Clinical Imaging Problem Identified
Problems that results from improper sequential activation of components.
Problems that results from improper sequential activation of components.
C92045
120
Electrical Problem Identified
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
3204
Biological Problem Identified
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
3230
Clinical Imaging Problem Identified
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
120
Electrical Problem Identified
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
202
Inappropriate Material
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
202
Inappropriate Material
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
642
Thermal Problem
Problems related to immunity or capabilities to resist electromagnetic interference (EMI).
Problems related to immunity or capabilities to resist electromagnetic interference (EMI).
C92046
197
Electromagnetic Compatibility Problem Identified
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
150
Labeling and Instructions for Use/Maintenance
Inadequate or incorrect information in the instructions for maintenance.
Inadequate or incorrect information in the instructions for maintenance.
C92071
150
Labeling and Instructions for Use/Maintenance
Problems that occur due to the physicochemical properties.
Problems that occur due to the physicochemical properties.
C92078
174
Material and/or Chemical Problem Identified
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
174
Material and/or Chemical Problem Identified
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
3213
Interoperability Problem Identified
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
174
Material and/or Chemical Problem Identified
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
110
Design Error
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
110
Design Error
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
180
Mechanical Problem Identified
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
114
Operational Problem Identified
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
150
Labeling and Instructions for Use/Maintenance
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
170
Manufacturing Process Problem Identified
Problems due to inadequate or incorrect electrical insulation material.
Problems due to inadequate or incorrect electrical insulation material.
C92045
120
Electrical Problem Identified
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
110
Design Error
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
Known interferent in the sample identified.
Known interferent in the sample identified.
C139467
4233
Patient Sample Problem
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
Problems caused by inadequate/broken seal within the device.
Problems caused by inadequate/broken seal within the device.
C92079
180
Mechanical Problem Identified
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
3224
Optical Problem Identified
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
3227
Power Source Problem Identified
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
180
Mechanical Problem Identified
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
3230
Clinical Imaging Problem Identified
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
170
Manufacturing Process Problem Identified
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
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
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
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
3204
Biological Problem Identified
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
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
3243
Stress Problem Identified
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
142
Biological Contamination
Safety measures are inadequately applied or missing.
Safety measures are inadequately applied or missing.
C92098
3228
Protective System Problem Identified
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
202
Inappropriate Material
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
3254
Genotoxicity Problem Identified
Communications problems between devices within a network system.
Communications problems between devices within a network system.
C92034
628
Communications Problem Identified
New or unknown endogenous or exogenous interferent (sample) identified.
New or unknown endogenous or exogenous interferent (sample) identified.
C139467
4233
Patient Sample Problem
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
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
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
110
Design Error
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
120
Electrical Problem Identified
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
C91801
FDA Manufacturer Evaluation Result Code Hierarchy
Problems with the device's ability to pass light energy.
Problems with the device's ability to pass light energy.
C92089
3224
Optical Problem Identified
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
642
Thermal Problem
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
111
Packaging Problem Identified
Problems that occurred because the packaging contained an incorrect device.
Problems that occurred because the packaging contained an incorrect device.
C92094
111
Packaging Problem Identified
Problems that occurred because unintended material was packaged with the device.
Problems that occurred because unintended material was packaged with the device.
C92094
111
Packaging Problem Identified
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
111
Packaging Problem Identified
Problems that occurred because of the device packaging.
Problems that occurred because of the device packaging.
C92076
170
Manufacturing Process Problem Identified
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
The device affects the body's ability to activate platelet formation.
The device affects the body's ability to activate platelet formation.
C92060
3255
Hematological Problem Identified
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
3227
Power Source Problem Identified
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
120
Electrical Problem Identified
Incorrect pre-analytical handling of patient's sample by the user.
Incorrect pre-analytical handling of patient's sample by the user.
C139467
4233
Patient Sample Problem
A system intended to indicate the device status was triggered prematurely.
A system intended to indicate the device status was triggered prematurely.
C92098
3228
Protective System Problem Identified
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
3255
Hematological Problem Identified
Malfunction of the device's self-test system.
Malfunction of the device's self-test system.
C92098
3228
Protective System Problem Identified
An auto stop function of a device did not operate correctly.
An auto stop function of a device did not operate correctly.
C92098
3228
Protective System Problem Identified
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
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
3230
Clinical Imaging Problem Identified
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
197
Electromagnetic Compatibility Problem Identified
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
174
Material and/or Chemical Problem Identified
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
3204
Biological Problem Identified
The device does not reset properly.
The device does not reset properly.
C92098
3228
Protective System Problem Identified
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
Inadequate shielding of/by the device.
Inadequate shielding of/by the device.
C92098
3228
Protective System Problem Identified
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
120
Electrical Problem Identified
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
120
Electrical Problem Identified
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
104
Software Problem Identified
The device software was not maintained/updated properly.
The device software was not maintained/updated properly.
C92113
104
Software Problem Identified
C91801
FDA Manufacturer Evaluation Result Code Hierarchy
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
104
Software Problem Identified
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
104
Software Problem Identified
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
104
Software Problem Identified
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
110
Design Error
Problems that occurred during terminal sterilization by the manufacturer.
Problems that occurred during terminal sterilization by the manufacturer.
C92076
170
Manufacturing Process Problem Identified
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
180
Mechanical Problem Identified
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
4246
Transport/Storage Problem Identified
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
180
Mechanical Problem Identified
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
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
174
Material and/or Chemical Problem Identified
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
4246
Transport/Storage Problem Identified
Problems was caused by transport or storage conditions.
Problems was caused by transport or storage conditions.
C91801
FDA Manufacturer Evaluation Result Code Hierarchy
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
3213
Interoperability Problem Identified
Problems due to unintended emission of electromagnetic energy by the device.
Problems due to unintended emission of electromagnetic energy by the device.
C92046
197
Electromagnetic Compatibility Problem Identified
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
3204
Biological Problem Identified
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
3243
Stress Problem Identified
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
3243
Stress Problem Identified
Communications problems between devices within a wired system.
Communications problems between devices within a wired system.
C92034
628
Communications Problem Identified
Communications problems between devices within a wireless system.
Communications problems between devices within a wireless system.
C92034
628
Communications Problem Identified
Cramps, Abdominal
An involuntary muscular contraction involving a muscle of the abdomen or of a hollow organ within the abdomen.
C34827
2193
Cramp(s)
The unintentional or intentional loss of a pregnancy before 22 weeks gestation.
C54450
FDA Patient Problem Code Hierarchy
All products of conception are expelled and identified.
Expulsion of all the products of conception following spontaneous, medical or operative pregnancy termination.
C35221
1688
Abortion
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
1688
Abortion
Abortion, Artificial
Artificial Abortion
Induced Abortion
Abortion brought on intentionally.
Abortion brought on intentionally.
C35221
1688
Abortion
Retention in uterus of an abortus that has been dead at least 4 weeks.
Retention in uterus of an abortus.
C35221
1688
Abortion
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
2348
Injury
An inflammatory process characterized by the accumulation of pus within a newly formed tissue cavity which is the result of a bacterial, fungal, or parasitic infection or the presence of a foreign body.
C2890
1735
Infection, Bacterial
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
Injury to the hearing mechanisms within the inner ear, caused by excessively loud noise.
C54450
FDA Patient Problem Code Hierarchy
A fibrous band of tissue that connects normally separate body regions.
C54450
FDA Patient Problem Code Hierarchy
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
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
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
1829
Embolism
Blockage of air flow in the respiratory tract.
C54450
FDA Patient Problem Code Hierarchy
C54450
FDA Patient Problem Code Hierarchy
Difficulties, Ambulation
Any persistent problem with walking.
C54450
FDA Patient Problem Code Hierarchy
Inflammation of the amnion.
Inflammation of the amnion.
C54450
FDA Patient Problem Code Hierarchy
Resembling anaphylaxis.
C54450
FDA Patient Problem Code Hierarchy
ALCL
A peripheral (mature) T-cell lymphoma, consisting of usually large anaplastic, CD30 positive cells. The majority of cases are positive for the anaplastic large cell lymphoma (ALK) protein. The most frequently seen genetic alteration is a t(2;5) translocation. Majority of patients present with advanced disease. The most important prognostic indicator is ALK positivity, which has been associated with a favorable prognosis. (WHO, 2001)
C3208
3263
Lymphoma
Failure of a surgically-induced connection between tubular structures in the body.
C54450
FDA Patient Problem Code Hierarchy
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
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
Bulging or ballooning in an area of an artery secondary to arterial wall weakening.
C54450
FDA Patient Problem Code Hierarchy
Paroxysms of chest pain due to reduced oxygen to the heart.
C54450
FDA Patient Problem Code Hierarchy
Absence or reduction of oxygen in body tissue.
C3890
1918
Hypoxia
C25637
2414
Reaction
Apprehension of danger and dread accompanied by restlessness, tension, tachycardia, and dyspnea unattached to a clearly identifiable stimulus.
C54450
FDA Patient Problem Code Hierarchy
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
Dysfunction of the aortic valve characterized by incomplete valve closure.
C50796
1926
Insufficiency, Valvular
The backward flow of blood from the aorta into the left ventricle, owing to insufficiency of the aortic semilunar valve; it may be chronic or acute.
The backward flow of blood from the aorta into the left ventricle, owing to insufficiency of the aortic semilunar valve; it may be chronic or acute.
C51223
1715
Aortic Insufficiency
Narrowing of the orifice of the aortic valve or of the supravalvular or subvalvular regions.
Narrowing of the orifice of the aortic valve.
C62433
2697
Valvular Stenosis
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
A procedure that collects a component of the peripheral blood while returning the rest to the donor.
C54450
FDA Patient Problem Code Hierarchy
Excision of the apex of the petrous portion of the temporal bone.
C54450
FDA Patient Problem Code Hierarchy
Arrest, Respiratory
Respiratory Arrest
Cessation of breathing.
Transient cessation of respiration.
C54450
FDA Patient Problem Code Hierarchy
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
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
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
A vascular disorder characterized by thickening and hardening of the walls of the arteries.
C54450
FDA Patient Problem Code Hierarchy
Joint Pain
Pain, Joint
Pain in a joint.
Pain in a joint.
C3303
1994
Pain
An inflammatory process affecting a joint. Causes include infection, autoimmune processes, degenerative processes, and trauma. Signs and symptoms may include swelling around the affected joint and pain.
C35760
2373
Joint Disorder
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
1723
Arthritis
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
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
1918
Hypoxia
A disorder characterized by inhalation of solids or liquids into the lungs.
C54450
FDA Patient Problem Code Hierarchy
A chronic respiratory disease manifested as difficulty breathing due to the narrowing of bronchial passageways.
C54450
FDA Patient Problem Code Hierarchy
Build-up of fatty material and calcium deposition in the arterial wall resulting in partial or complete occlusion of the arterial lumen.
C34398
1722
Arteriosclerosis
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
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
A rupture in atrial tissue due to traumatic or pathologic processes.
C54450
FDA Patient Problem Code Hierarchy
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
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
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
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
Excessive Blinking
C54450
FDA Patient Problem Code Hierarchy
Abnormal Blood Gas Measurements
Measurements, Abnormal Blood Gas
C54450
FDA Patient Problem Code Hierarchy
Loss Of Blood
Loss of blood from the circulation, either internally or externally.
C54450
FDA Patient Problem Code Hierarchy
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
A rupture in the wall of the small or large intestine due to traumatic or pathologic processes.
C4080
2001
Perforation
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
Brain Damage
Injury, Brain
Trauma to the brain.
C54450
FDA Patient Problem Code Hierarchy
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
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
An acute or chronic inflammatory process affecting the bronchi.
C54450
FDA Patient Problem Code Hierarchy
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
2011
Pneumonia
Sudden contraction of the smooth muscles of the bronchial wall.
C54450
FDA Patient Problem Code Hierarchy
Injury of the soft tissues or bone without breaking the skin that is characterized by blood leakage into the surrounding area.
C3671
2348
Injury
Injury to tissues caused by contact with dry heat, moist heat, flames, chemicals, electricity, friction or radiant and electromagnetic energy. A first degree burn is associated with redness, a second degree burn with vesication and a third degree burn with necrosis through the entire skin.
A traumatic injury involving interruption of tissue cohesiveness that results from exposure to caustic chemicals, extreme heat, extreme cold or excessive radiation.
C3671
2348
Injury
Bowel Burn
C34441
1757
Burn(s)
Corneal Burn
Chemical or radiant injury to the cornea.
C34441
1757
Burn(s)
Burns, Thermal
Thermal Burn
A burn injury caused by heat or fire.
C34441
1757
Burn(s)
Sensation, Burning
A sensation of stinging or heat, not necessarily accompanied by redness or physical signs of irritation.
C54450
FDA Patient Problem Code Hierarchy
Calcium Deposit(s)
Deposit(s), Calcium
Deposition of calcium in the tissues. It may be the result of a metabolic disorder or long-standing infection, or it may be associated with the presence of cancer.
C9442
1809
Deposits
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
Breast Cancer
A carcinoma arising from the breast, most commonly the terminal ductal-lobular unit. It is the most common malignant tumor in females. Risk factors include country of birth, family history, menstrual and reproductive history, fibrocystic disease and epithelial hyperplasia, exogenous estrogens, contraceptive agents, and ionizing radiation. The vast majority of breast carcinomas are adenocarcinomas (ductal or lobular). Breast carcinoma spreads by direct invasion, by the lymphatic route, and by the blood vessel route. The most common site of lymph node involvement is the axilla.
C9305
3262
Cancer
C54450
FDA Patient Problem Code Hierarchy
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
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
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
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
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
Arrest, Cardiopulmonary
Cessation of breathing and/or cardiac function.
Cessation of breathing and/or cardiac function.
C54450
FDA Patient Problem Code Hierarchy
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
Induced Cataract
A cataract that has been produced artificially or by induction, e.g. as a result of device use, medication, trauma, tears, falls, accidental injury, etc.
A cataract that has been produced artificially or by induction, e.g. as a result of device use, medication, trauma, tears, falls, accidental injury, etc.
C26713
1766
Cataract
Burn, Caustic/Chemical
Chemical/Caustic Burn
A burn caused by exposure to chemical substances.
C34441
1757
Burn(s)
Inflammation of the dermis and subcutaneous tissues caused by a bacterial infection. Symptoms include erythema, edema, and pain to the affected area.
C2890
1735
Infection, Bacterial
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
Ventriculomeglia
Abnormal enlargement of the cerebral ventricles.
C50448
2078
Ventricle, Abnormality Of
Fluid, Leakage Of Cerebrospinal
Leakage Of Cerebrospinal Fluid
The loss of cerebrospinal fluid into the surrounding tissues.
C54450
FDA Patient Problem Code Hierarchy
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
Cervical Change
Changes, Cervical
Changes such as abnormal, pathological, benign, malignant, etc.
An alteration in the cervix.
C54450
FDA Patient Problem Code Hierarchy
Exposure, Chemical
Contact with a chemical substance through touch, inhalation, or ingestion.
C54450
FDA Patient Problem Code Hierarchy
Excessive edema of the ocular conjunctiva.
Edema of the mucous membrane of the eyeball and eyelid lining.
C3002
1820
Edema
Pain In Chest
Pain in the chest.
C3303
1994
Pain
Pressure/Tightness In Chest
Tightness/Pressure In Chest
C54450
FDA Patient Problem Code Hierarchy
Shivering or moderate tremors of the body often accompanied by a cold sensation.
C54450
FDA Patient Problem Code Hierarchy
Interference with respiration by compression or obstruction of the larynx or trachea.
C3671
2348
Injury
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
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
Limping or lameness.
Pain, cramping, and fatigue of the lower extremities upon ambulation due to ischemia.
C54450
FDA Patient Problem Code Hierarchy
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
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
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
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
Failure of a physiologic function or system.
C54450
FDA Patient Problem Code Hierarchy
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
Ill-Defined Complaint
C54450
FDA Patient Problem Code Hierarchy
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
A violent jar or shock, or the condition which results from such an injury.
A violent jar or shock, or the condition which results from such an injury.
C3671
2348
Injury
Disorientation/Confusion
A mental state characterized by a lack of clear and orderly thought and behavior.
C54450
FDA Patient Problem Code Hierarchy
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
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
Inflammation of the conjunctiva of the eye.
C54450
FDA Patient Problem Code Hierarchy
Disease, Connective Tissue
Tissue Disease, Connective
A non-neoplastic or neoplastic disorder that affects the connective tissue.
C54450
FDA Patient Problem Code Hierarchy
Irregular and infrequent or difficult evacuation of the bowels.
C54450
FDA Patient Problem Code Hierarchy
A bruise; an injury of a part without a break in the skin.
A bruise due to trauma.
C3671
2348
Injury
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
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
Perforation Of Cornea
A rupture in the corneal tissue due to traumatic or pathologic processes
C54450
FDA Patient Problem Code Hierarchy
Injury to the epithelium of the cornea.
C54450
FDA Patient Problem Code Hierarchy
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
Edema, Corneal
Hazy, swollen cornea.
Hazy, swollen cornea.
C3002
1820
Edema
Opacity within the cornea.
C54450
FDA Patient Problem Code Hierarchy
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
Scar, Corneal
Replacement of corneal tissue with scar tissue as a result of injury to the deeper layers of the cornea.
C34483
2061
Scarring
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
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
A sustained, sudden and involuntary contraction of a muscle or group of muscles.
C54450
FDA Patient Problem Code Hierarchy
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
Injury, Crushing
Traumatic compression of the body or a part of the body.
C3671
2348
Injury
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
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
Inflammation of the ciliary body.
Inflammation of the ciliary body.
C54450
FDA Patient Problem Code Hierarchy
Formation Of Cyst(s)
A morphologic finding indicating the presence of cystic structures in a tissue sample.
C54450
FDA Patient Problem Code Hierarchy
Retinitis, Cytomegaloviral
Inflammation of the retina due to cytomegalovirus.
C54450
FDA Patient Problem Code Hierarchy
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
An inherited or acquired condition characterized by the inability to hear in one or both ears.
C35731
1882
Hearing Loss
Expired/Death
The cessation of life.
C54450
FDA Patient Problem Code Hierarchy
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
Bone Shedding Debris
Shedding Of Bone Debris
Shedding of accumulated bone fragments.
Shedding of accumulated bone fragments.
C54450
FDA Patient Problem Code Hierarchy
C50416
1718
Apgar Score, Decreased Or Low
C25637
2414
Reaction
A splitting open of an anatomical structure, zone, or organ with the exposure or discharge of its content.
C54450
FDA Patient Problem Code Hierarchy
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
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
Dialysis Dementia
A severe, often fatal encephalopathy which has been attributed to accumulation in the brain of aluminum from dialysate prepared with inadequately purified water.
A severe, often fatal encephalopathy which has been attributed to accumulation in the brain of aluminum from dialysate prepared with inadequately purified water.
C26920
1833
Encephalopathy
Accumulation of extraneous inorganic matter in tissues or cavities.
C54450
FDA Patient Problem Code Hierarchy
A melancholy feeling of sadness and despair.
C54450
FDA Patient Problem Code Hierarchy
Inflammation of the skin and muscle.
C2889
1732
Autoimmune Disease
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
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
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
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
Watery bowel movements.
C54450
FDA Patient Problem Code Hierarchy
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
Any physical or mental impairment that interferes with an individual's ability to perform desired activities.
C54450
FDA Patient Problem Code Hierarchy
C54450
FDA Patient Problem Code Hierarchy
The leakage of a substance from an orifice or wound.
C54450
FDA Patient Problem Code Hierarchy
A feeling of mental or physical uneasiness, pain, or distress.
C54450
FDA Patient Problem Code Hierarchy
Permanent deformation of appearance.
C54450
FDA Patient Problem Code Hierarchy
C54450
FDA Patient Problem Code Hierarchy
Coagulation (DIC), Disseminated Intravascular
DIC, Disseminated Intravascular Coagulation
Disseminated Intravascular Coagulation
Intravascular Coagulation (DIC), Disseminated
A disorder characterized by reduction in the elements involved in blood coagulation due to their utilization in widespread blood clotting within the vessels.
A pathological process where the blood starts to coagulate throughout the whole body. This depletes the body of its platelets and coagulation factors, and there is an increased risk of hemorrhage.
C2902
1779
Coagulopathy
The condition of being stretched beyond normal dimensions.
C54450
FDA Patient Problem Code Hierarchy
A state of physiological or psychological stress that cannot be compensated for by normal adaptive measures.
C54450
FDA Patient Problem Code Hierarchy
A sensation of lightheadedness, unsteadiness, turning, spinning or rocking.
C54450
FDA Patient Problem Code Hierarchy
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
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
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
Impairment of verbal communication skills, often resulting from brain damage.
C54450
FDA Patient Problem Code Hierarchy
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
Difficulty or pain in urination.
Pain or discomfort during urination.
C54450
FDA Patient Problem Code Hierarchy
A flat discoloration of the skin or a mucous membrane, larger in area than a petechia, caused by the extravasation of blood.
C26791
1888
Hemorrhage
Accumulation of an excessive amount of fluid in cells or intercellular tissues.
C3399
2091
Swelling
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
Microcytic Edema
Corneal edema of inflammatory origin associated with contact lens wear and morphologically characterized by presence of epithelial microcysts. Microcysts are small (typically 10-50 microns in diameter), clear, irregularly shaped high refractive inclusions that form in the basal layers of the epithelium and move towards the anterior surface of the cornea, surrounding epithelial haze. The cause of microcytic edema is related to the physical presence of contact lenses and possibly a mechanical effect of lens wear.
C50508
1791
Corneal Edema
Stromal Edema
Fluid from the aqueous humor enters the corneal stroma and causes swelling.
Fluid from the aqueous humor enters the corneal stroma and causes swelling.
C50508
1791
Corneal Edema
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
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
The passage of electrical current through the body.
The passage of electrical current through the body.
C54450
FDA Patient Problem Code Hierarchy
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
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
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
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
Changes, Emotional
C54450
FDA Patient Problem Code Hierarchy
Pulmonary Emphysema
A condition of the lung characterized by increase beyond normal in the size of air spaces distal to the terminal bronchioles, either from dilatation of the alveoli or from destruction of their walls.
A subcategory of chronic obstructive pulmonary disease (COPD). It occurs in people who smoke and suffer from chronic bronchitis. It is characterized by inflation of the alveoli, alveolar wall damage, and reduction in the number of alveoli, resulting in difficulty breathing.
C3199
2237
Chronic Obstructive Pulmonary Disease, (COPD)
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
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
Inflammation of the endocardium.
C54450
FDA Patient Problem Code Hierarchy
An infectious process affecting the internal structures of the eye.
C54450
FDA Patient Problem Code Hierarchy
Cardiac Enzyme Elevation
Elevation Of Cardiac Enzymes
C54450
FDA Patient Problem Code Hierarchy
An eating away or breakdown of any type of external or internal human tissue including but not limited to skin, teeth, mucosa, or somatic, which involves only the outer tissue layer. When tissue surrounds an implanted device, the tissue breakdown may result in migration and loss of the implant material and may result in further complications such as infection or abscess.
An eating away or breakdown of any type of external or internal human tissue including but not limited to skin, teeth, mucosa, or somatic, which involves only the outer tissue layer. When tissue surrounds an implanted device, the tissue breakdown may result in migration and loss of the implant material and may result in further complications such as infection or abscess.
C61375
2681
Tissue Breakdown
To belch, the casting of upwind from the stomach.
To belch, the casting of upwind from the stomach.
C54450
FDA Patient Problem Code Hierarchy
Red discoloration of the skin caused by infectious agents, inflammation, drug hypersensitivity, or underlying disease.
C3327
2074
Skin Discoloration
Laceration(s) Of Esophagus
A torn, ragged, mangled wound, or an accidental cut of esophagus.
C54450
FDA Patient Problem Code Hierarchy
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
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
Extensive loss of blood due to internal or external hemorrhage.
Extensive loss of blood due to internal or external hemorrhage.
C50470
2597
Blood Loss
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
Exhaustion, Extreme
Extreme fatigue; inability to respond to stimuli.
Extreme fatigue; inability to respond to stimuli.
C3036
1849
Fatigue
The removal of a previously inserted tube from a hollow organ or passageway, often from the airway.
C54450
FDA Patient Problem Code Hierarchy
Injury, Eye
Damage to the eye.
C54450
FDA Patient Problem Code Hierarchy
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
Extremely weak; threatened with syncope.
Extremely weak; threatened with syncope.
C50635
2418
Loss Of Consciousness
A sudden movement downward, usually resulting in injury.
C54450
FDA Patient Problem Code Hierarchy
Inflammation of fascia.
Inflammation process in fascia.
C54450
FDA Patient Problem Code Hierarchy
Overall tiredness and lack of energy.
C54450
FDA Patient Problem Code Hierarchy
Problems, Feeding
C54450
FDA Patient Problem Code Hierarchy
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
Elevation of body temperature above normal due to inflammatory or immune responses.
C54450
FDA Patient Problem Code Hierarchy
Inflammation and fibrous degeneration of a muscle.
Inflammation and fibrous degeneration of a muscle.
C54450
FDA Patient Problem Code Hierarchy
The formation of fibrous tissue; fibroid or fibrous degeneration.
The formation of fibrous tissue.
C54450
FDA Patient Problem Code Hierarchy
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
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
1757
Burn(s)
Abnormal epithelial-lined communication between two anatomical structures.
C54450
FDA Patient Problem Code Hierarchy
A sudden or brief burst of light.
The perception of sudden or brief bursts (flashes) of light.
C54450
FDA Patient Problem Code Hierarchy
Gas or air in the gastrointestinal tract.
Gas or air in the gastrointestinal tract.
C54450
FDA Patient Problem Code Hierarchy
The pouring forth of a fluid.
C54450
FDA Patient Problem Code Hierarchy
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
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
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
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
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
A traumatic injury to the bone in which the continuity of the bone is broken.
C54450
FDA Patient Problem Code Hierarchy
A traumatic break in one or more of the bones in the arm or forearm.
C3046
1870
Fracture(s)
Delayed Union Fracture
Union Fracture, Delayed
A bone fracture that is taking an abnormally long time to heal.
C3046
1870
Fracture(s)
Hip Fracture
Traumatic or pathological injury to the hip in which the continuity of either the femoral head, femoral neck, intertrochanteric or subtrochanteric regions is broken. Symptoms include pain in the hip or groin, bruising and swelling in and around the hip area. The injured hip is turned outward and the leg appears shorter on that side.
C3046
1870
Fracture(s)
Skull Fracture
A traumatic or pathologic injury to the bones of the skull in which the continuity of the bones of the skull is broken.
C3046
1870
Fracture(s)
Tooth Fracture
Broken tooth affecting any portion of tooth: root fracture, crown-root, broken tooth (crown fracture), chipped tooth. A crown fracture can involve the pulp. Tooth fracture sequelae range in severity from cosmetic defects to tooth death. Involvement of the pulp is a more important indicator of severity of tooth fracture than is the amount of the tooth affected.
C3046
1870
Fracture(s)
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
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
Inflammation of the stomach.
C54450
FDA Patient Problem Code Hierarchy
Increased pressure in the eyeball due to obstruction of the outflow of aqueous humor.
C54450
FDA Patient Problem Code Hierarchy
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
Perforation, Great Vessel
C50804
2135
Vessels, Perforation Of
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
Hazy ring around bright lights seen by some patients with refractive error or optical defects, e.g. cataracts, or corneal swelling.
Hazy ring around bright lights seen by some patients with refractive error or optical defects, e.g. cataracts, or corneal swelling.
C27123
2137
Blurred Vision
Injury, Head
A traumatic injury to the head.
C54450
FDA Patient Problem Code Hierarchy
Pain in various parts of the head, not confined to the area of distribution of any nerve.
C54450
FDA Patient Problem Code Hierarchy
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
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
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
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
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
Abdominal discomfort with retrosternal pain usually associated with gastroesophageal reflux..
C3303
1994
Pain
C54450
FDA Patient Problem Code Hierarchy
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
Blood in the urine.
C54450
FDA Patient Problem Code Hierarchy
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
Disruption of the integrity of the erythrocyte membrane causing release of hemoglobin.
C54450
FDA Patient Problem Code Hierarchy
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
Coughing up blood from the respiratory tract.
C54450
FDA Patient Problem Code Hierarchy
Bleeding
The flow of blood from a ruptured blood vessel.
C54450
FDA Patient Problem Code Hierarchy
Bleeding, Cerebral
Cerebral Bleeding
Cerebral Hemorrhage
Hemorrhage into the cerebrum. See also Stroke Syndrome.
Bleeding within the cerebrum.
C50438
1891
Intracranial Hemorrhage
Extradural Hemorrhage
Intracranial hemorrhage into the epidural space.
Intracranial hemorrhage into the epidural space.
C26791
1888
Hemorrhage
Intraventricular Hemorrhage
Bleeding into the brain's ventricles.
C50485
1889
Hemorrhage, Cerebral
Subarachnoid Hemorrhage
Intracranial hemorrhage into the subarachnoid space.
Intracranial hemorrhage into the subarachnoid space.
C26791
1888
Hemorrhage
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
1888
Hemorrhage
Hemorrhage, Subgaleal
Bleeding between the scalp and the periosteum.
C26791
1888
Hemorrhage
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
A collection of blood in the pleural cavity.
A collection of blood in the pleural cavity.
C54450
FDA Patient Problem Code Hierarchy
Inflammation of the liver; usually from a viral infection, but sometimes from toxic agents.
C54450
FDA Patient Problem Code Hierarchy
The protrusion of part of an organ or fibroadipose tissue through an abnormal opening.
C54450
FDA Patient Problem Code Hierarchy
Any inflammatory skin disease caused by a herpesvirus and characterized by the formation of small vesicles in clusters.
Any inflammatory skin disease caused by a herpesvirus and characterized by the formation of small vesicles in clusters.
C3439
2248
Infection, Viral
An involuntary contraction of the diaphragm against closed vocal cords, producing the "hic" sound.
C54450
FDA Patient Problem Code Hierarchy
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
Reaction Of Host-Tissue
Tissue, Reaction Of Host
Growth of tissue in or around a foreign body as the body's antibody response to the foreign body.
Growth of tissue in or around a foreign body as the body's antibody response to the foreign body.
C50444
1868
Foreign Body Reaction
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
A disorder characterized by an abnormal increase of cerebrospinal fluid in the ventricles of the brain.
C54450
FDA Patient Problem Code Hierarchy
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
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
Blood Glucose, High
Glucose, High Blood
High Blood Glucose
Abnormally high level of glucose in the blood.
C54450
FDA Patient Problem Code Hierarchy
Higher than normal levels of sodium in the circulating blood.
C54450
FDA Patient Problem Code Hierarchy
An abnormal increase in the number of cells in an organ or a tissue with consequent enlargement.
C54450
FDA Patient Problem Code Hierarchy
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
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
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
Abnormally prolonged, rapid, and deep breathing.
Abnormally prolonged, rapid, and deep breathing.
C54450
FDA Patient Problem Code Hierarchy
Too much fluid in the blood.
C54450
FDA Patient Problem Code Hierarchy
Hemorrhage within the anterior chamber of the eye; bloodshot.
Hemorrhage within the anterior chamber of the eye; bloodshot.
C54450
FDA Patient Problem Code Hierarchy
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
Consisting of abnormally decreased sensitivity, particularly to touch.
Consisting of abnormally decreased sensitivity, particularly to touch in the arm or hand.
C50445
2352
Hypoesthesia
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
2352
Hypoesthesia
Blood Glucose, Low
Glucose, Low Blood
Low Blood Glucose
Abnormally low level of glucose in the blood.
C54450
FDA Patient Problem Code Hierarchy
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
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
Body Temperature, Decreased
Decreased Body Temperature
Temperature, Decreased Body
Abnormally low body temperature.
Abnormally low body temperature.
C54450
FDA Patient Problem Code Hierarchy
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
Abnormally decreased volume of circulating fluid (plasma) in body.
Abnormally decreased volume of circulating fluid (plasma) in body.
C54450
FDA Patient Problem Code Hierarchy
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
Caused by conditions such as inadequate placental function (often abruptio placentae), preeclamptic toxicity, prolapse of the umbilical cord, or complications from anesthetic administration.
Hypoxia in utero, caused by conditions such as inadequate placental function (often abruptio placentae), preeclamptic toxicity, prolapse of the umbilical cord, or complications from anesthetic administration.
C3890
1918
Hypoxia
Source, Iatrogenic
C54450
FDA Patient Problem Code Hierarchy
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
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
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
Persistent or recurrent inability to achieve or to maintain an erection during sexual activity.
C54450
FDA Patient Problem Code Hierarchy
Insufficient structural and functional connection between living bone and the surface of a synthetic implant.
C54450
FDA Patient Problem Code Hierarchy
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
Involuntary passage of stool or urine from the body.
C54450
FDA Patient Problem Code Hierarchy
Sensitivity
C25637
2414
Reaction
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
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
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
1930
Infection
Direct Infection
Infection produced by direct contact with another person.
Infection produced by direct contact with another person.
C26726
1930
Infection
Fungal Infection
An infection caused by a fungus.
C26726
1930
Infection
Indirect Infection
Infection transmitted by water, food or other means of conveyance.
Infection transmitted by water, food or other means of conveyance.
C26726
1930
Infection
Intraocular Infection
Infection within the eye.
Infection within the eye.
C26726
1930
Infection
Pyrogenic Infection
An infection caused by pus-producing organisms.
An infection caused by pus-producing organisms.
C26726
1930
Infection
Subclinical Infection
Infection associated with no detectable symptoms but caused by microorganisms capable of producing easily recognizable diseases, such a poliomyelitis or mumps.
Infection associated with no detectable symptoms but caused by microorganisms capable of producing easily recognizable diseases, such a poliomyelitis or mumps.
C26726
1930
Infection
An infectious process affecting the upper respiratory tract (nose, paranasal sinuses, pharynx, larynx, or trachea). Symptoms include congestion, sneezing, coughing, fever, and sore throat.
C26726
1930
Infection
Tract, Infection Of Urinary
Urinary Tract Infection
A bacterial infectious process affecting any part of the urinary tract, most commonly the bladder and the urethra. Symptoms include urinary urgency and frequency, burning sensation during urination, lower abdominal discomfort, and cloudy urine.
C26726
1930
Infection
Viral Infection
Any disease caused by a virus.
C26726
1930
Infection
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
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
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
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
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
Uterine bleeding that occurs during a time not associated with the normal menstrual period.
C26791
1888
Hemorrhage
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
Bleeding, Intracranial
Hemorrhage, Intracranial
Intracranial Bleeding
Bleeding within the cranium.
Bleeding within the cranium.
C26791
1888
Hemorrhage
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
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
C3303
1994
Pain
Inflammation of the iris.
Inflammation of the iris.
C54450
FDA Patient Problem Code Hierarchy
Excited response to stimuli.
C54450
FDA Patient Problem Code Hierarchy
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
Lack of blood supply to an area of the body, resulting in impairment of tissue oxygenation.
C54450
FDA Patient Problem Code Hierarchy
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
An intense itching sensation.
C54450
FDA Patient Problem Code Hierarchy
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
Dislocated Joint
An abnormal separation where two or more bones meet.
C35760
2373
Joint Disorder
Disorder, Joint
Any disorder of the joints.
C54450
FDA Patient Problem Code Hierarchy
Swelling, Joint
The presence of swelling in a joint.
C35760
2373
Joint Disorder
Inflammation of the cornea.
C54450
FDA Patient Problem Code Hierarchy
Acanthamoeba Keratitis
Keratitis due to infection by acanthamoeba; it is usually associated with soft contact lens wear, particularly overnight wear.
Keratitis due to infection by acanthamoeba; it is usually associated with soft contact lens wear, particularly overnight wear.
C26805
1944
Keratitis
Premature Labor
Regular uterine activity with associated cervical change prior to 37 weeks gestation.
C54450
FDA Patient Problem Code Hierarchy
A cut or tear in any tissue.
C3671
2348
Injury
C34441
1757
Burn(s)
C35016
2072
Shock
Dysfunction, Left Ventricular
Ventricular Dysfunction, Left
Impairment of the left ventricle to either fill or eject adequately.
C54450
FDA Patient Problem Code Hierarchy
Failure, Left Ventricular
Ventricular Failure, Left
Failure of adequate output by the left ventricle despite an increase in distending pressure and in end-diastolic volume, with dyspnea, orthopnea, and other signs and symptoms of pulmonary congestion and edema.
Failure of adequate output by the left ventricle despite an increase in distending pressure and in end-diastolic volume, with dyspnea, orthopnea, and other signs and symptoms of pulmonary congestion and edema.
C50577
2206
Heart Failure
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
Characterized by a lack of vitality or energy.
C54450
FDA Patient Problem Code Hierarchy
Damage To Ligament(s)
An injury to any of the fibrous bands of tissue that comprise an articulation (joint).
C3671
2348
Injury
C50603
1924
Implant, Failure Of
Contusion, Liver
Bruising of the liver.
Bruising of the liver.
C50441
1787
Contusion
Dysfunction, Liver
A finding that indicates abnormal liver function.
C54450
FDA Patient Problem Code Hierarchy
Laceration(s), Liver
A cut or tear in the liver.
C54450
FDA Patient Problem Code Hierarchy
An inability to purposefully respond to stimuli.
C54450
FDA Patient Problem Code Hierarchy
Pulse, Loss Of
C54450
FDA Patient Problem Code Hierarchy
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
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
An autoimmune, connective tissue chronic inflammatory disorder affecting the skin, joints, kidneys, lungs, heart, and the peripheral blood cells. It is more commonly seen in women than men. Variants include discoid and systemic lupus erythematosus.
C2889
1732
Autoimmune Disease
A malignant (clonal) proliferation of B- lymphocytes or T- lymphocytes which involves the lymph nodes, bone marrow and/or extranodal sites. This category includes Non-Hodgkin lymphomas and Hodgkin lymphomas.
C9305
3262
Cancer
A feeling of general discomfort or uneasiness, an out-of-sorts feeling.
C54450
FDA Patient Problem Code Hierarchy
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
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
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
A disorder characterized by acute inflammation of the meninges of the brain and/or spinal cord.
C54450
FDA Patient Problem Code Hierarchy
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
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
A sudden compelling urge to urinate.
An acute and compelling urge to urinate.
C54450
FDA Patient Problem Code Hierarchy
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
1688
Abortion
C54450
FDA Patient Problem Code Hierarchy
Dose, Missed
A dose of medicine that was not taken at the prescribed dosing interval.
C54450
FDA Patient Problem Code Hierarchy
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
Insufficiency, Mitral
Dysfunction of the mitral valve characterized by incomplete valve closure.
C50796
1926
Insufficiency, Valvular
Perforation, Mitral
A rupture in the mitral valve tissue due to traumatic or pathologic processes.
C54450
FDA Patient Problem Code Hierarchy
Regurgitation, Mitral
The backward flow of blood from the left ventricle into the left atrium, owing to insufficiency of the mitral valve; it may be acute or chronic, usually due to mitral valve prolapse, rheumatic heart disease or a complication of cardiac dilatation.
The backward flow of blood from the left ventricle into the left atrium, owing to insufficiency of the mitral valve; it may be acute or chronic, usually due to mitral valve prolapse, rheumatic heart disease or a complication of cardiac dilatation.
C50888
1963
Mitral Insufficiency
Stenosis, Mitral
Narrowing of the left atrioventricular mitral orifice.
Narrowing of the left atrioventricular mitral orifice.
C62433
2697
Valvular Stenosis
Prolapse, Mitral Valve
Valve, Prolapse Of Mitral
Prolapse of the mitral valve, often with regurgitation, associated with myxomatous proliferation of the leaflets of the mitral valve.
A fairly common and often benign valvular heart disorder characterized by redundancy or hooding of mitral valve leaflets so that they prolapse into the left atrium, often causing mitral regurgitation. It is often a symptomless condition but may be marked by varied symptoms (e.g. chest pain, fatigue, dizziness, dyspnea, or palpitations) leading in some cases to endocarditis or ventricular tachycardia.
C36173
2475
Prolapse
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
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
Stimulation Of Muscle
C54450
FDA Patient Problem Code Hierarchy
Weakness, Muscular
A reduction in the strength of one or more muscles.
C54450
FDA Patient Problem Code Hierarchy
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
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
Painful sensation originating from a muscle or group of muscles.
C3303
1994
Pain
Cardiac Contusion
Contusion, Cardiac
Contusion, Myocardial
A bruise to the heart.
A bruise to the heart.
C50441
1787
Contusion
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
Inflammation of the muscle tissue of the heart.
C54450
FDA Patient Problem Code Hierarchy
Obstruction, Nasal
Blockage of the nasal passages.
C3284
2422
Obstruction
Upper abdominal discomfort associated with an urge to vomit.
C54450
FDA Patient Problem Code Hierarchy
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
Flap Tissue, Necrosis Of
Tissue, Necrosis Of Flap
C54450
FDA Patient Problem Code Hierarchy
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
Deformities, Neonatal
A congenital anatomic abnormality manifested during the neonatal period.
C2849
1782
Congenital Defect/Deformity
Hearing Impairment, Neonatal
Impairment To Hearing, Neonatal
An abnormality that affects hearing within the first month after birth. It may or may not result in hearing loss.
C2849
1782
Congenital Defect/Deformity
Hearing Loss, Neonatal
Loss Of Hearing, Neonatal
Partial or complete loss of the ability to detect or understand sounds present in an infant within its first month after birth.
C2849
1782
Congenital Defect/Deformity
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
Damage To Nerve(s)
Injury to nervous tissue.
C54450
FDA Patient Problem Code Hierarchy
C54450
FDA Patient Problem Code Hierarchy
Stimulation Of Nerve, Undesired
Undesired Nerve Stimulation
C54450
FDA Patient Problem Code Hierarchy
Injury in the central or peripheral nervous system.
C3671
2348
Injury
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
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
Changes In/Loss Of Nipple Sensation
Loss Of/Changes In Nipple Sensation
Sensation, Changes In/Loss Of Nipple
C54450
FDA Patient Problem Code Hierarchy
Ulceration, Nipple
Ulcer that develops in the nipple. Causes include trauma and Paget disease.
C54450
FDA Patient Problem Code Hierarchy
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
Consequences Or Impact To Patient, None
Impact Or Consequences To Patient, None
Patient, No Consequences Or Impact To
C54450
FDA Patient Problem Code Hierarchy
C48655
3192
Missing Value Reason
C54450
FDA Patient Problem Code Hierarchy
C54450
FDA Patient Problem Code Hierarchy
A loss of the sensation of feeling in an area of the body.
C54450
FDA Patient Problem Code Hierarchy
Blockage of the normal flow of the contents of an anatomical passageway.
C54450
FDA Patient Problem Code Hierarchy
The act of closure or the state of being closed; an obstruction; the relationship between all of the components of the masticatory system in normal function, dysfunction, and parafunction; momentary complete closure of some area in the vocal tract, causing stoppage of the breath and accumulation of pressure.
Obstruction or a closure of hollow organ, passageway or vessel; also the transient approximation of the edges of a natural opening; imperforation.
C3284
2422
Obstruction
Damage To Optical Nerve(s)
Nerve Damage, Optical
C50669
1979
Nerve Damage
Tissue, Breakdown Of Optical
C34602
1845
Eye Injury
Perforation Of Organ(s)
C4080
2001
Perforation
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
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
Bone Loss
Decreased calcification or density of bone tissue.
C54450
FDA Patient Problem Code Hierarchy
Exposure to, or intake of, an excessive amount of a substance.
C54450
FDA Patient Problem Code Hierarchy
A level of sedation that is greater than the intended level.
C54450
FDA Patient Problem Code Hierarchy
C54450
FDA Patient Problem Code Hierarchy
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
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
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
The sensation of discomfort, distress, or agony, resulting from the stimulation of specialized nerve endings.
C54450
FDA Patient Problem Code Hierarchy
Inadequate Pain Relief
C54450
FDA Patient Problem Code Hierarchy
Abdominal Pain
Painful sensation in the abdominal region.
C3303
1994
Pain
Neck Pain
Painful sensation in the neck area.
C3303
1994
Pain
An unusual or extreme paleness, state of decreased skin or mucosal coloration.
C54450
FDA Patient Problem Code Hierarchy
An unpleasant sensation of irregular and/or forceful beating of the heart.
C54450
FDA Patient Problem Code Hierarchy
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
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
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
A slight or incomplete paralysis.
A slight or incomplete paralysis.
C3310
1997
Paralysis
C36292
2695
Test Result
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
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
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
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
A hole or opening made through a membrane or other tissue or material.
C3671
2348
Injury
Fluid collection within the pericardial sac, usually due to inflammation.
C54450
FDA Patient Problem Code Hierarchy
Injury occurring as a result of the delivery process.
Injury to the brain of a newborn infant occurring around the time of birth.
C50440
2219
Brain Injury
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
Laceration(s), Peritoneal
A cut or tear of the peritoneum.
C54450
FDA Patient Problem Code Hierarchy
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
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
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
Inflammation of a vein.
C54450
FDA Patient Problem Code Hierarchy
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
A nonimmunologic, chemically induced type of photosensitivity.
A nonimmunologic, chemically induced type of photosensitivity.
C54450
FDA Patient Problem Code Hierarchy
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
2348
Injury
Having different forms at different stages of the life cycle.
C54450
FDA Patient Problem Code Hierarchy
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
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
Abnormal presence of air in the pleural cavity.
C54450
FDA Patient Problem Code Hierarchy
Erosion, Pocket
Erosion of patient's skin pocket which houses a device.
Erosion of patient's skin pocket which houses a device.
C50443
1750
Erosion
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
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
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
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
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
Necrosis, Pressure
Pressure, Necrosis
Sores/Ulcers, Pressure
Ulcers/Sores, Pressure
Death of tissue due to external pressure.
Death of tissue due to external pressure.
C3426
2274
Ulcer
A condition in which an organ or body tissue drops or bulges out of place.
C54450
FDA Patient Problem Code Hierarchy
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
The drooping of the upper eyelid.
C54450
FDA Patient Problem Code Hierarchy
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
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
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
Dysfunction, Pulmonary
C54450
FDA Patient Problem Code Hierarchy
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
Embolism, Pulmonary
The closure of the pulmonary artery or one of its branches by an embolus, sometimes associated with infarction of the lung.
The obstruction of the pulmonary artery or one of its branches by an embolus, sometimes associated with infarction of the lung.
C26759
1829
Embolism
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
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
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
Stenosis, Pulmonary
Narrowing of the opening between the pulmonary artery and the right ventricle, usually at the level of the valve leaflets.
Narrowing of the opening between the pulmonary artery and the right ventricle, usually at the level of the valve leaflets.
C62433
2697
Valvular Stenosis
Pulse, Diminished
Weak or absent palpable pulse due to decreased arterial pulse pressure.
C54450
FDA Patient Problem Code Hierarchy
Irregular Pulse
A pulse that beats at irregular intervals.
Not rhythmic pulse irregular in beat or accent.
C54450
FDA Patient Problem Code Hierarchy
Block, Pupillary
An obstruction of the pupil.
An obstruction of the pupil.
C54450
FDA Patient Problem Code Hierarchy
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
2686
Fluid Discharge
Paralysis of all four limbs.
Paralysis of all four limbs.
C54450
FDA Patient Problem Code Hierarchy
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
Burn, Radiation
A burn caused by exposure to x-ray, radium, sunlight, atomic or any other type of radiant energy.
A burn caused by exposure to x-ray, radium, sunlight, atomic or any other type of radiant energy.
C34441
1757
Burn(s)
C54450
FDA Patient Problem Code Hierarchy
Overdose Of Radiation
A higher than intended cumulative dose of radiation to a single field.
C50873
1988
Overdose
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
Underdose, Radiation
An inadequate amount of a radiation treatment.
C50428
2542
Underdose
A cutaneous inflammatory reaction occurring as a result of exposure to biologically effective levels of ionizing radiation.
A cutaneous inflammatory reaction occurring as a result of exposure to biologically effective levels of ionizing radiation.
C2983
2443
Skin Inflammation
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
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
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
A response generated by a stimulus.
C54450
FDA Patient Problem Code Hierarchy
Injection Site Reaction
An intense reaction (usually immunologic) developing at the site of injection
C25637
2414
Reaction
Local Reaction
A regionally-limited response to an antigen, which may include inflammation, induration, erythema, pruritus or pain.
C25637
2414
Reaction
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
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
Valvular Regurgitation
Regurgitation of the blood of the heart valves owning to imperfect closing, insufficiency or incompetency of the valves.
Regurgitation of the blood of the heart valves owning to imperfect closing, insufficiency or incompetency of the valves.
C50796
1926
Insufficiency, Valvular
The infusion of autogenic body fluid that has previously been withdrawn from the patient.
C54450
FDA Patient Problem Code Hierarchy
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
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
C54450
FDA Patient Problem Code Hierarchy
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
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
Distress, Respiratory
A pathological increase in the effort and frequency of breathing movements.
C54450
FDA Patient Problem Code Hierarchy
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
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
Decreased Respiratory Rate
Rate Of Respiration, Decreased
Abnormal decrease of rate of breathing.
C54450
FDA Patient Problem Code Hierarchy
Increased Respiratory Rate
Rate Of Respiration, Increased
Abnormal increase of rate of breathing.
C54450
FDA Patient Problem Code Hierarchy
Damage To Retina
Injury to the retina due to advanced age, toxicity, exposure to bright lights, or trauma.
C34602
1845
Eye Injury
Degeneration Of Retina
Degeneration of the retina.
C54450
FDA Patient Problem Code Hierarchy
A usually small tearing of the retina occurring when the vitreous separates from the retina. It may lead to retinal detachment. Symptoms include flashes and floaters.
C50731
2048
Retina, Damage To
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
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
Failure, Right Ventricular
Ventricular Failure, Right
Failure of proper functioning of the right ventricle, with venous engorgement, hepatic enlargement, and subcutaneous edema.
Failure of proper functioning of the right ventricle, with venous engorgement, hepatic enlargement, and subcutaneous edema.
C50733
2054
Right Ventricular Dysfunction
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
Forcible tearing or disruption of tissue.
C3671
2348
Injury
Excision, Scar
A surgical procedure to reduce the appearance of a scar.
C54450
FDA Patient Problem Code Hierarchy
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
A permanent mark left on the skin in the process of wound healing.
C3044
3167
Fibrosis
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
1732
Autoimmune Disease
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
1757
Burn(s)
The process of allaying nervous excitement or the state of being calmed. (Taber's)
C54450
FDA Patient Problem Code Hierarchy
Convulsion
Sudden, involuntary skeletal muscular contractions of cerebral or brain stem origin.
C54450
FDA Patient Problem Code Hierarchy
Petit-Mal Seizures
Seizures, Petit-Mal
The seizure seen in absence epilepsy, consisting of a sudden momentary break in consciousness of thought or activity, often accompanied by automatisms or clonic movements, especially of the eyelids.
Generalized seizure that manifests in a form of a brief episode of impairment of consciousness with or without accompanying motor phenomena such as clonic-tonic components, automatisms, or autonomic components.
C2962
2063
Seizures
Focal Seizures
Partial seizure.
A transitory alteration in movement, sensation or autonomic nerve function due to abnormal electric activity in a localized area of the cerebral cortex, usually without change in awareness or alertness. Symptoms vary with different lesion locations and may include but not limited to the motor (e.g. rhythmic muscle contractions in one area of the body), somatosensory and sensory alterations manifested by abnormal numbness, paresthesias or other hallucinations, including several types of aura; autonomic and psychic symptoms, e.g. with changes in speech, thought, personality, mood, sensation of deja vu or hallucinations.
C2962
2063
Seizures
Focal Motor Seizures
A simple partial seizure consisting of clonus or spasm of a muscle or muscle group; it may be single or in a continuous and repetitive series or may spread to adjacent muscles.
A simple partial seizure consisting of clonus or spasm of a muscle or muscle group; it may be single or in a continuous and repetitive series or may spread to adjacent muscles.
C50689
2260
Seizures, Focal
Grand-Mal Seizures
A symptomatic form of epilepsy often preceded by an aura; characterized by loss of consciousness with generalized tonic- clonic seizures.
A generalized tonic-clinic seizure, characterized by loss of consciousness. This type of seizure may be preceded by an aura and is frequently followed by a period of confusion and lethargy (post-ictal state).
C2962
2063
Seizures
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
A tumor-like collection of serum in the tissues.
A collection of serum in the body.
C54450
FDA Patient Problem Code Hierarchy
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
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
Acoustic Shock
Neurophysiological and psychological symptoms caused by sudden and unexpected loud noise.
C3671
2348
Injury
Anaphylactic Shock
Anaphylaxis
Systemic anaphylaxis is the most dramatic example of an immediate hypersensitivity reaction; is uncommon and unexpected in nature and occasionally results in a fatal outcome.
Progression of anaphylaxis into systemic shock, which is characterized by significant reduction in tissue perfusion which leads to hypoxia and hypotension, and can lead to death if untreated.
C35016
2072
Shock
Cardiogenic Shock
Shock resulting from primary failure of the heart in its pumping function, as in myocardial infarction, severe cardiomyopathy, or mechanical obstruction or compression of the heart.
Shock resulting from primary failure of the heart in its pumping function, as in myocardial infarction, severe cardiomyopathy, or mechanical obstruction or compression of the heart.
C35016
2072
Shock
Hypovolemic Shock
Shock resulting from insufficient blood volume for the maintenance of adequate cardiac output, blood pressure and tissue perfusion.
Shock resulting from insufficient blood volume for the maintenance of adequate cardiac output, blood pressure and tissue perfusion.
C35016
2072
Shock
Insulin Shock
A hypoglycemic reaction to overdosage of insulin, a skipped meal, or strenuous exercise in an insulin-dependent diabetic.
A hypoglycemic reaction to overdosage of insulin, a skipped meal, or strenuous exercise in an insulin-dependent diabetic.
C35016
2072
Shock
Neurogenic Shock
Shock resulting from neurogenic vasodilation, which can be produced by cerebral trauma or hemorrhage, spinal cord injury, deep general or spinal anesthesia, or toxic central nervous system depression.
Shock resulting from neurogenic vasodilation, which can be produced by cerebral trauma or hemorrhage, spinal cord injury, deep general or spinal anesthesia, or toxic central nervous system depression.
C35016
2072
Shock
Postoperative Shock
A state of shock following a surgical operation.
A state of shock following a surgical operation.
C35019
2267
Shock, Surgical
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
2072
Shock
Surgical Shock
Hypoperfusion of body tissues occurring during or after a surgical procedure, and resulting in cellular injury and vital organ dysfunction.
C35016
2072
Shock
Traumatic Shock
Any shock produced by trauma.
Any shock produced by trauma.
C35016
2072
Shock
Perforation Of Sinus
A rupture in the sinus tissue due to traumatic or pathologic processes.
C4080
2001
Perforation
Syndrome, Sjogren's
An autoimmune disorder affecting the salivary and lacrimal glands. Morphologically, it is characterized by the presence of lymphocytic and plasmacytic infiltrates which cause destruction of these glands. It results in dry mouth and dry eyes. It may be associated with the presence of other autoimmune disorders, including rheumatoid arthritis and lupus erythematosus.
C2889
1732
Autoimmune Disease
Discoloration Of Skin
Abnormal skin coloration.
C54450
FDA Patient Problem Code Hierarchy
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
1750
Erosion
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
Irritation Of Skin
A mild inflammatory dermal tissue reaction; it can be caused by physical contact with an irritant or can be a local response to a systemic trigger.
C50624
1941
Irritation
A break in skin tissue caused by friction or shearing.
C54450
FDA Patient Problem Code Hierarchy
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
A symptom consisting of the involuntary expulsion of air from the nose.
C54450
FDA Patient Problem Code Hierarchy
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
Injury, Spinal Cord
Traumatic damage of the spinal cord.
C4974
2689
Nervous System Injury
Injury, Spinal
Damage to the spine that results in impaired function.
C3671
2348
Injury
A stretching or tearing of a ligament.
C3671
2348
Injury
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
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
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
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
Stricture
Narrowing or stricture of a duct or canal.
Narrowing or stricture of a vessel, duct or canal.
C54450
FDA Patient Problem Code Hierarchy
Neck Stiffness
Limited mobility of the neck, usually accompanied by pain.
C54450
FDA Patient Problem Code Hierarchy
Chocking or arrest of respiration due to occlusion of the air passageway; arrest of circulation in a part due to compression.
Chocking or arrest of respiration due to occlusion of the air passageway; arrest of circulation in a part due to compression.
C3671
2348
Injury
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
1802
Death
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
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
Wearing away of the surface of a suture as a result of bending and frictional forces.
C50449
1689
Abrasion
A watery secretion by the sweat glands that is primarily composed of salt, urea and minerals.
C54450
FDA Patient Problem Code Hierarchy
Enlargement; expansion in size; sign of inflammation
C54450
FDA Patient Problem Code Hierarchy
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
Lymph Nodes, Swollen
Nodes, Swollen Lymph
The presence of an enlarged lymph node.
C54450
FDA Patient Problem Code Hierarchy
Faint
A spontaneous loss of consciousness caused by insufficient blood supply to the brain.
C54450
FDA Patient Problem Code Hierarchy
Inflammation of a synovial membrane.
Inflammation of a synovial membrane.
C54450
FDA Patient Problem Code Hierarchy
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
Excessive Tearing
Profuse lacrimation.
C54450
FDA Patient Problem Code Hierarchy
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
Tears, Tentorial
Pertaining to tears involving the tentorium of the cerebellum.
Pertaining to tears involving the tentorium of the cerebellum.
C50440
2219
Brain Injury
Effects, Teratogenic
The result of processes that negatively affect a developing fetus.
C54450
FDA Patient Problem Code Hierarchy
The outcome of a laboratory test.
C54450
FDA Patient Problem Code Hierarchy
Effects, Unexpected Therapeutic
Unexpected Therapeutic Effects
Unanticipated desirable and beneficial effects resulting from a medical treatment.
C54450
FDA Patient Problem Code Hierarchy
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
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
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
1757
Burn(s)
Occlusion of the lumen of a vessel by a thrombus that has migrated from a distal site via the blood stream.
C26759
1829
Embolism
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
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
Problems, Thyroid
C54450
FDA Patient Problem Code Hierarchy
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
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
A process caused by injury or disease or aging and characterized by a partial/complete disruption of tissue. The disruption may be temporary or permanent and may be associated with either (1) impairment or (2) loss of function of the affected organ(s) or system(s).
C50773
2104
Tissue Damage
Damage, Tissue
C3671
2348
Injury
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
2132
Ventricular Tachycardia
The condition resulting from the spread of bacterial products (toxins) by the bloodstream.
The condition resulting from the spread of bacterial products (toxins) by the bloodstream.
C2890
1735
Infection, Bacterial
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
The finding of bodily harm due to the poisonous effects of something.
C3671
2348
Injury
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
Acquired Toxoplasmosis
Acquired as an adult.
Toxoplasmosis acquired in adulthood.
C54450
FDA Patient Problem Code Hierarchy
Congenital Toxoplasmosis
Passed from mother to fetus.
Toxoplasma infection that is present from birth.
C54450
FDA Patient Problem Code Hierarchy
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
Insufficiency, Tricuspid
Incomplete closure of the tricuspid valve, resulting in tricuspid regurgitation; it is usually secondary to systolic overload in the right ventricle.
Dysfunction of the pulmonary valve characterized by incomplete valve closure.
C50796
1926
Insufficiency, Valvular
Regurgitation, Tricuspid
The backflow of blood from the right ventricle into the right atrium, owning to imperfect functioning/insufficiency of the tricuspid valve.
The backflow of blood from the right ventricle into the right atrium, owning to imperfect functioning/insufficiency of the tricuspid valve.
C50842
2111
Tricuspid Insufficiency
Stenosis, Tricuspid
Narrowing or stricture of the tricuspid orifice of the heart.
Narrowing or stricture of the tricuspid orifice of the heart.
C62433
2697
Valvular Stenosis
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
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
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
A circumscribed inflammatory and often suppurating lesion on the skin or an internal mucous surface resulting in necrosis of tissue.
C3671
2348
Injury
The formation or development of an ulcer.
C54450
FDA Patient Problem Code Hierarchy
An inadequate amount of a treatment.
C54450
FDA Patient Problem Code Hierarchy
A laboratory test result indicating abnormally high concentration of non-protein nitrogen in the blood.
C54450
FDA Patient Problem Code Hierarchy
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
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
Hives
Urticaria.
A transient, itchy skin eruption characterized by wheals with pale interiors and red margins.
C2983
2443
Skin Inflammation
Perforation Of Uterus
A rupture in the uterus due to traumatic or pathologic processes.
C4080
2001
Perforation
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
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
Damage, Vaginal Mucosa
Mucosa Damage, Vaginal
C3671
2348
Injury
Narrowing of the opening of one or more of the four valves of the heart.
C50754
2263
Stenosis
Impaired Circulation
C54450
FDA Patient Problem Code Hierarchy
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
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
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
Disease (VD), Venereal
VD, Venereal Disease
Venereal Disease (VD)
Any contagious disease acquired during sexual contact; e.g. syphilis, gonorrhea, chancroid.
A disorder acquired through sexual contact.
C26726
1930
Infection
The collection of blood from a vein, most commonly via needle venipuncture.
C54450
FDA Patient Problem Code Hierarchy
Dependent, Ventilator
C54450
FDA Patient Problem Code Hierarchy
C54450
FDA Patient Problem Code Hierarchy
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
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
2132
Ventricular Tachycardia
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
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
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
2687
Foreign Body In Patient
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
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
Impaired Vision
Sight that is impaired.
C54450
FDA Patient Problem Code Hierarchy
Loss Of Vision
A condition in which the ability to see is impaired.
C54450
FDA Patient Problem Code Hierarchy
Disturbances, Visual
An interference to normal eyesight.
C54450
FDA Patient Problem Code Hierarchy
Surgical removal of the vitreous humor from the chamber of the eye.
C54450
FDA Patient Problem Code Hierarchy
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
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
Fluid, Loss Of Vitreous
Loss Of Vitreous Fluid
C54450
FDA Patient Problem Code Hierarchy
Detachment Of Vitreous
Detachment of the vitreous humor from the retina.
C54450
FDA Patient Problem Code Hierarchy
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
Forceful ejection of the contents of the stomach through the mouth.
C54450
FDA Patient Problem Code Hierarchy
The property of lacking physical strength.
C54450
FDA Patient Problem Code Hierarchy
Fluctuations Of Weight
Repetitive loss and regain of body weight.
C54450
FDA Patient Problem Code Hierarchy
Welt(s)
A smooth, slightly elevated area on the body surface, which is redder or paler than the surrounding skin. It is the typical lesion of urticaria, the dermal evidence of allergy, and in sensitive persons may be provoked by mechanical irritation of the skin.
A smooth, slightly elevated area on the body surface, which is redder or paler than the surrounding skin. It is the typical lesion of urticaria, the dermal evidence of allergy, and in sensitive persons may be provoked by mechanical irritation of the skin.
C50624
1941
Irritation
Dehiscence Wound
Separation of the layers of a surgical wound; it may be partial and superficial only, or complete with disruption of all layers.
Splitting of the sutured margins of a surgical wound. Risk factors include diabetes mellitus, obesity, and advanced age.
C50527
2502
Dehiscence Of Organ
Infection, Post-Operative Wound
Post-Operative Wound Infection
Infection of a surgical skin incision.
C54450
FDA Patient Problem Code Hierarchy
Infection, Post-Traumatic Wound
Post-Traumatic Wound Infection
Infection of a wound following trauma.
C54450
FDA Patient Problem Code Hierarchy
C54450
FDA Patient Problem Code Hierarchy
Rupture of the fibrous strands connecting the ciliary body and the crystalline lens of the eye.
C50527
2502
Dehiscence Of Organ