BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3124023 · Received May 17, 2013

    Report

    Report Number
    1720753-2013-06169
    Event Type
    Malfunction
    Date Received
    May 17, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 17, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE BACKPLANE WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SYSTEM DISPLAYS INTERMITTENT GENERATOR FRAME SYNC ERRORS AND AN X-RAY DISABLED ERROR MESSAGE. BOTH ERRORS WERE ATTRIBUTED TO THE SAME ROOT CAUSE. THE RESULT OF WHICH WAS A LOSS OF FLUOROSCOPY X-RAY. THERE WAS NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219264 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1