BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 1071056 · Received July 10, 2008

    Report

    Report Number
    1720753-2008-22754
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 20, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP RELOADED SOFTWARE AND CMOS SETTINGS; VERIFIED PROPER SYSTEM OPERATION BY BOOTING SYSTEM AND MAKING EXPOSURES X20.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WOULD NOT BOOT. THEY PLUGGED SYSTEM IN TO TURN ON AND THE SCREEN STAYS BLANK. THE CONTROL PANNEL IS THE ONLY THING THAT LIGHTS UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1