Health / Medical Topics |
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 pacemaker. (Food and Drug Administration)
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Issue associated with the failure of the device to perform a self-calibration procedure or process designed to assure the accuracy and proper…
Issue associated with the inability of a device to turn itself off when the device is not in an operable condition. …
Issue associated with the expiration date or shelf life of a product.
Issue associated with errors in identification of expiration date.
Terminology that represents results of evaluation used by the CDRH with respect to reporting Medical Device events.
Terminology that represents methods of evaluation used by the CDRH with respect to reporting Medical Device events.