Device Process Evaluation Method

Performing a review of the manufacturing and production processes and/or records for a specific device or lot that may have contributed to problems with a device. (Food and Drug Administration)

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Device Problem

Medical device failure or malfunction associated with device functions, including any deviations from documented specifications, requirements, and intended uses.

Device Pressure Testing Evaluation Method

Testing the device's characteristics when subjected to high or low pressure conditions.

Device Power Source Testing Evaluation Method

Testing the power sources in a device e.g., battery, internal power supply to detect any malfunction.

Device Power Source Problem Evaluation Result

Problems that are related to the device that provides power.

Device Power Frequency Magnetic Field Testing Evaluation Method

Tests performed to verify a device's level of protection (immunity) against magnetic disturbances while operating.

Device Power Fluctuation Evaluation Result

The device or component failed due to fluctuations within the power supply (e.g. transient power, power spike, power dip, or power…