BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1220629 · Received October 31, 2008

    Report

    Report Number
    9617766-2008-01399
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 28, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TO REPAIR THE SYSTEM, THE GE SERVICE REP HAD TO PERFORM THE JV 5.5 8800 VERSION SBC UPGRADE. THIS INCLUDED THE CPU KIT, IMAGE PROCESSOR, DISPLAY ADAPTER, AND THE GENERATOR PCB. THE FOOTSWITCH WAS REPLACED DUE TO A BREAK IN THE CABLE. THE SYSTEM IS NOW OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM HAS LOCKED UP SEVERAL TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1