BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9400

    MDR report key: 1000641 · Received February 21, 2008

    Report

    Report Number
    1720753-2008-16291
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 21, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE FAILURE WAS VERIFIED. THE GENERATOR BATTERIES WERE FOUND TO BE WEAK AND LEAKING. THE BATTERIES WERE NOT ORIGINAL EQUIPMENT AND THE WIRING HAD BEEN MODIFIED. THERE ARE NO LONGER PARTS AVAILABLE. A FOLLOW UP REPORT WILL BE FILED WHEN ADD'L DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WS REPORTED THAT THE 9400 SYSTEM WOULD NOT BOOT UP AND HAD A PRECHARGE ERROR CODE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9400 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1