BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3231037 · Received July 12, 2013

    Report

    Report Number
    1720753-2013-08084
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 29, 2013
    Report Date
    July 12, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE HIGH VOLTAGE CABLE, INTERCONNECT CABLE, HIGH VOLTAGE TANK, X-RAY TUBE, IGBT SNUBBER BOARD, GENERATOR DRIVER BOARD AND SYSTEM BATTERIES WERE REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE FIELD ENGINEER REPORTED THAT THE SYSTEM WAS DISPLAYING OVERLOAD FAULT ERROR MESSAGES AND HAD MAJOR ARCING. THIS WILL CAUSE THE SYSTEM TO SHUT DOWN. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324095 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1