BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1141083 · Received September 3, 2008

    Report

    Report Number
    1720753-2008-24414
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    July 28, 2008
    Report Date
    August 7, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM FUNCTIONED ON ARRIVAL BUT AFTER 6 MINUTES OF FLUORO IT FAILED. THE GE REP RESEATED ALL CABLES TO FILAMENT DRIVER BOARD AND GEN DRIVER BOARDS, RESEATED HV SUPPLY REGULATOR BOARD, GIB, AND FFB BOARDS. HE VERIFIED GENERATOR POWER SUPPLY VOLTAGES, ALL ARE WITHIN SPEC. HE VERIFIED FILAMENT DRIVE SIGNALS AND KV DRIVE SIGNALS ON GEN DRIVER AND FILAMENT DRIVER BOARDS. HE BOOTED THE SYSTEM SEVERAL TIMES AND MADE X-RAYS WITHOUT FAULT. SYSTEM THEN FUNCTIONED WITHOUT ERROR FOR TWO HOURS. THE UNIT IS FUNCTIONAL AND OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT PRODUCED NO IMAGE WHEN FLUOROING AND THE TRACKING WENT TO 120 KV AND 6.27 MA. NO PATIENTS WERE INJURED. ANOTHER C-ARM WAS USED TO COMPLETE THE CASE.

    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