BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3142745 · Received May 24, 2013

    Report

    Report Number
    1720753-2013-06410
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 24, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE HIGH VOLTAGE CABLE WAS CLEANED AND REGREASED AND THE FILAMENT WAS CALIBRATED 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

    THE CUSTOMER REPORTED A DISPLAYED OVERLOAD FAULT ERROR MESSAGE. THIS ERROR WILL LIKELY RESULT IN A SYSTEM SHUT DOWN SITUATION. THERE ARE NO REPORTS OF PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232768 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1