Medical Device Evaluation Conclusions Terminology FDA CDRH

Terminology that represents conclusions of an evaluation used by the CDRH with respect to reporting Medical Device events. (NCI Thesaurus)

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Medical Device Emits Smoke

Issue associated with a cloud of vapor or gas generated from the device, generally associated after a fire or a burn. …

Medical Device Embedded In Vessel Or Plaque

Device and/or fragments of device are embedded in patient's vessel and/or plaque.

Medical Device Electronic Property Issue

Issue associated with any deviations from device documented performance specifications relating to devices, circuits, or systems utilizing electrons and in association with…

Medical Device Electrical Issue

Issue associated with a failure of the electrical circuitry or components of the device.

Medical Device Difficult to Prepare

Issue associated with the use of the device in terms of user experiencing difficulty in preparing the device for use, even if…

Medical Device Deployment Issue

Issue associated with any deviations from device documented performance specifications relating to the sequence of events for activation and positioning of the…