BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4090034 · Received August 18, 2014

    Report

    Report Number
    1720753-2014-07052
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    August 2, 2014
    Report Date
    August 18, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. 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

    IT WAS REPORTED THE SYSTEM DISPLAYED A GENERATOR ERROR MESSAGE. THIS LIKELY RESULTED IN A SYSTEM LOCKUP, NO BOOT, OR SHUT DOWN SITUATION. THERE ARE NO REPORTS OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496304 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1