BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1173017 · Received September 19, 2008

    Report

    Report Number
    1720753-2008-26115
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 19, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP REMOVED AND REPLACED THE SNUBBER BOARD. HE ALSO, INSPECTED THE HIGH VOLTAGE CANDLE STICKS TO MAKE SURE THERE WAS NO ARCING THAT COULD HAVE CAUSED BLOWN FUSE ON SNUBBER BOARD. HE TESTED AND VERIFIED THE GENERATOR CALIBRATIONS INCLUDING: FILAMENT OUTPUT, MA NULL ADJUSTMENT, RAMP PEAK VOLTAGE, DEAD TIME ADJUSTMENT AND FILAMENT CALIBRATION. THE SYSTEM WORKS AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEY WERE NOT GETTING AN IMAGE ON THE LEFT FLUORO MONITOR. NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1