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. (Food and Drug Administration)

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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…

Medical Device Failure to Calibrate

Issue associated with the failure of the device to perform a self-calibration procedure or process designed to assure the accuracy and proper…

Medical Device Failure to Auto Stop

Issue associated with the inability of a device to turn itself off when the device is not in an operable condition. …

Medical Device Expiration Date Issue

Issue associated with the expiration date or shelf life of a product.

Medical Device Expiration Date Error

Issue associated with errors in identification of expiration date.

Medical Device Evaluation Results Terminology FDA CDRH

Terminology that represents results of evaluation used by the CDRH with respect to reporting Medical Device events.