BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 869979 · Received June 25, 2007

    Report

    Report Number
    1720753-2007-02452
    Event Type
    Malfunction
    Date Received
    June 25, 2007
    Date of Event
    May 28, 2007
    Report Date
    June 25, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE FAILURE WAS CONFIRMED. THE FILAMENT WAS CALIBRATED. THE BATTERY AND TRANSFORMER WERE REPLACED WITH NON-OCE EQUIPMENT BY THE HOSPITAL MED-TECH. THE SYSTEM WAS FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9800 SYSTEM HAD A FILAMENT REGULATOR FAILURE, CHARGER FAILURE ERROR MESSAGE. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR