BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1232594 · Received November 13, 2008

    Report

    Report Number
    9617766-2008-01425
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 10, 2008
    Report Date
    November 13, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEM INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP CHECKED THE SYSTEM, BUT FOUND NO PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FLUORO IMAGE WAS SUDDENLY TURNED BLACK OUT WITH NO ERROR MESSAGE. HE REBOOT THE SYSTEM AND WORKED WITH NO PROBLEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1