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 suspended matter. (Food and Drug Administration)

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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…

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.