BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 4180151 · Received October 15, 2014

    Report

    Report Number
    1720753-2014-08626
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 25, 2014
    Report Date
    October 14, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE X-RAY TUBE WAS REPLACED 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

    IT WAS REPORTED THAT THE SYSTEM INTERMITTENTLY GIVES OVERLOAD FAULTS AND THE SYSTEM WOULD NOT FLUORO. THIS RESULTED IN AN INTERMITTENT, RECOVERABLE LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655116 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1