BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1992926 · Received February 5, 2011

    Report

    Report Number
    1720753-2011-00968
    Event Type
    Malfunction
    Date Received
    February 5, 2011
    Date of Event
    January 17, 2011
    Report Date
    February 5, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE FILAMENT DRIVER BOARD, GENERATOR DRIVER BOARD, GENERATOR INTERFACE BOARD, BACKPLANE, X-RAY TUBE, HIGH VOLTAGE TANK, SNUBBER BOARD, AND HIGH VOLTAGE CABLE TO CORRECT INTERMITTENT ARCING, COMMUNICATION FAILURES, AND MA ERROR MESSAGES DURING FLUORO. REPLACED THE INTERCONNECT CABLE BECAUSE OF CUTS IN CABLE, AND THE BATTERY PACK. PERFORMED A GENERATOR CALIBRATION. A FILAMENT CALIBRATION AND VERIFIED THE UNIT FUNCTIONS AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED AN MA SENSOR FAILURE MESSAGE AND THE IMAGE QUALITY IS POOR. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1