BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 1000577 · Received February 21, 2008

    Report

    Report Number
    1720753-2008-16331
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 21, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADD'L INFO AT THIS TIME. WHEN ADD'L INFO IS PROVIDED, IT WILL BE REPORTED AS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 6800 SYS FAILED WHILE IN USE. IT WAS NOTED THAT A HIGH PITCH SOUND WAS COMING FROM THE "C" BEHIND THE CONTROL PANEL AND AN ERROR MESSAGE "X-RAY DISABLES" WAS DISPLAYED. THERE WAS NO REPORT OF PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR