Health / Medical Topics

    Device Incorrectly Prepared for Use or Modified Evaluation Conclusion

    A device that is incorrectly modified or prepared for use by distributor, service provider, or user facility. (Food and Drug Administration)




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    A device that malfunctions due to a component(s) that does not operate correctly and according to the device's specifications.
    Observing the device in the exact same conditions and setting in which the device was used.
    Device problems that occur due to the presence of a material that should not be present or part of the device. …
    Device problems associated with the improper combination of materials or elements present in the device (e.g., improper composition of the materials of…
    Testing the resistance to current flow in a device's circuit or component.
    A device that experienced problems due to insufficient or excessive resistance to AC current flow either by the device or circuit. …

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