BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600+

    MDR report key: 982024 · Received January 22, 2008

    Report

    Report Number
    1720753-2008-00638
    Event Type
    Malfunction
    Date Received
    January 22, 2008
    Date of Event
    January 8, 2008
    Report Date
    January 22, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP DISCUSSED THE REPORTED PROBLEM WITH THE FACILITY BIO-MEDICAL ENGINEER AND WAS ADVISED THAT THEY WOULD COMPLETE THE FIX/REPAIR AND WOULD HOLD OFF ON OEC SERVICE. IF ADD'L INFO BECOMES AVAILABLE IT WILL BE REPORTED AS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9600+ SYSTEM C-ARM DISPLAYED AN ERROR CODE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600+ FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 9600+ NA

    Patients

    Seq Age Sex Outcome Treatment
    1