Health / Medical Topics

    Device Wear Problem Evaluation Result

    Device problems due to the premature or expected erosion of its material by use, deterioration, or change. (Food and Drug Administration)




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    Testing the device for its immunity when subjected to positive and negative low amplitude voltage fluctuations.
    Evaluating a device for problems resulting from periodic or random mechanical oscillations which could induce damage.
    Device problems caused by the constant rhythmic motion of the device, a device's component, or something in the environment to which theā€¦
    Questioning a pre-defined group of users about their practices.
    Any testing performed that simulates real use situations experienced by users.
    Terminology used in Individual Case Safety Reports to specify a type of device usage, section H8 of FDA MedWatch Form.

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