BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPOSCOP 700

    MDR report key: 850707 · Received April 30, 2007

    Report

    Report Number
    850707
    Event Type
    Malfunction
    Date Received
    April 30, 2007
    Date of Event
    April 26, 2007
    Report Date
    April 30, 2007
    Manufacturer
    ZIEHM IMAGING, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    A ZIEHM 7000 C-ARM WAS GIVING EXPOSURES AUTOMATICALLY WITHOUT THE EXPOSURE SWITCH BEING DEPRESSED. WE TRACED THE PROBLEM TO A FAULTY HAND SWITCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPOSCOP 700 X-RAY SYSTEM, PORTABLE C-ARM JAA ZIEHM IMAGING, INC. EXPOSCOP 7000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *