BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1441085 · Received August 18, 2009

    Report

    Report Number
    1720753-2009-03176
    Event Type
    Malfunction
    Date Received
    August 18, 2009
    Date of Event
    March 26, 2009
    Report Date
    April 21, 2009
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE GE SERVICE REP REMOVED AND REPLACED THE X-RAY TUBE, HIGH VOLTAGE GENERATOR TANK, BACKPLANE AND IGBT SNUBBER ASSEMBLY. HE PERFORMED A GENERATOR CALIBRATION AND PERFORMED A FILAMENT CALIBRATION USING UTILITY SUITE. THE SYSTEM OPERATES AS INTENDED. (B) (4) 06/17/2009.

    Additional Manufacturer Narrative · 1

    (B) (4). THE GE SERVICE REP REMOVED AND REPLACED THE X-RAY TUBE, HIGH VOLTAGE GENERATOR TANK, BACKPLANE AND IGBT SNUBBER ASSEMBLY. HE PERFORMED A GENERATOR CALIBRATION AND PERFORMED A FILAMENT CALIBRATION USING UTILITY SUITE. THE SYSTEM OPERATES AS INTENDED. (B) (4) 06/17/2009.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM INTERMITTENTLY GOES TO MAX TECHNIQUE, AND THERE WAS NO IMAGE ON THE LEFT MONITOR.

    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