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Device Fatigue Problem Evaluation Result
Device problems due to the weakening or breakdown of its material when subjected to stress or a series of repeated stresses. (Food and Drug Administration)
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A device problem related to the user not following the manufacturer's instructions.
A device that cannot calibrate (establish the relationship between a measuring device and the units of measure) to ensure accurate readings. …
A device problem that occurred in part or in total related to the patient's physiology.
A subject domain utilized for the submission of information encompassing and representing data, vocabulary or records related to device exposure.
A subject domain utilized for the submission of information encompassing and representing data, vocabulary or records related to device events.
Terminology used in Individual Case Safety Reports to specify a type of device evaluation.
