Health / Medical Topics

    Device Usage ICSR Terminology

    Terminology used in Individual Case Safety Reports to specify a type of device usage, section H8 of FDA MedWatch Form. (NCI Thesaurus)




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    An unused device that has been returned in packaging that remains intact.
    The device software contained code that could never be executed under any circumstance.
    Testing of individual hardware or software components or groups of related units.
    The device software did not correctly address abnormal execution of the code.
    A situation when a procedure or operation involving use of medical device is performed without required level of care, supervision, or constant…
    Testing the devices response to variations in air pressure for detecting sound with frequencies greater than upper limit of human hearing (>…

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