BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1040786 · Received May 9, 2008

    Report

    Report Number
    1720753-2008-21366
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 7, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP FOUND THE ISSUES THAT WERE CAUSED BY ARCING. HE CHECKED THE HIGH VOLTAGE RECEPTACLES AT TUBE AND AT HV TANK AND FOUND NO SIGNS OF ARCING. THE REP SHOT FLUORO EXPOSURE WHILE INCREASING KV AND FOUND ARC SOUND WAS COMING FROM TUBE HEAD. HE REPLACED THE XRAY TUBE. SHOT FLUORO EXPOSURES FOR SEVERAL MINUTES AT HIGH KV AND MA INCLUDING 30 SECONDS AT 120 KV AT 16 MA IN HLF MODE. NO ARCING WAS NOTED. REALIGNED COLLIMATOR. SYSTEM WORKS AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LOUD POPPING SOUND FOLLOWED BY WHITE SCREEN AND LOW MA ERROR. CASE WAS COMPLETED USING ANOTHER C-ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1