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Device Protective System Failure Evaluation Result
A device that fails when the system designed to ensure its safe operation fails. (Food and Drug Administration)
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A subject domain utilized for the submission of information encompassing and representing data, vocabulary or records related to device properties.
Performing a review of the manufacturing and production processes and/or records for a specific device or lot that may have contributed to…
Medical device failure or malfunction associated with device functions, including any deviations from documented specifications, requirements, and intended uses.
Testing the device's characteristics when subjected to high or low pressure conditions.
Testing the power sources in a device e.g., battery, internal power supply to detect any malfunction.
Problems that are related to the device that provides power.
