BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUOROSCOPIC X-RAY

    MDR report key: 2954125 · Received July 12, 2007

    Report

    Report Number
    1720753-2007-08894
    Event Type
    Malfunction
    Date Received
    July 12, 2007
    Date of Event
    June 19, 2007
    Report Date
    July 12, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. ADJUSTMENTS MADE TO PSQ. ERASED ALL FLASH MEMORY AND RELOADED CALIBRATION FILES. SYSTEM IS FUNCTIONAL AND OPERATING AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE CAMERA ROTATION BUTTON IS PRESSED ON THE 9800 SYSTEM, THE IMAGE SPINS COMPLETELY AROUND. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK