Health / Medical Topics

    Device Infrastructure Failure Evaluation Conclusion

    Device problems related to problems with the underlying framework, systems, and processes of an organization (e.g. as building power supply, network, oxygen systems). (Food and Drug Administration)




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    A device that is incorrectly modified or prepared for use by distributor, service provider, or user facility.
    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.

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