Medical Device Inoperable

Issue associated with the device being in a nonfunctional or inoperable state and cannot be used unless the causes of the inoperability are located and fixed. (Food and Drug Administration)

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Medical Device Incompatibility Problem

Issue associated with the device not being compatible with another device component or substance (medication, body fluid etc) that it contains or…

Medical Device Inappropriate Reset to Default

Issue associated with the inability to appropriately perform or generate any automated setting if no specific selection has made by the…

Medical Device Filtration Issue

Issue associated with the process of passing a substance through a porous medium, e.g., a blood clot filter for the removal of…

Medical Device Failure to Shut Off

Issue associated with the device not powering off when a shut down was requested.

Medical Device Failure to Self-Test

Issue associated with the device failing to perform an internal self-diagnostic process to ensure normal operation during or prior to use. …

Medical Device Failure to Capture

Issue associated with the failure to achieve effective and consistent depolarization of the heart resulting from the electrical stimulus of the…