BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 1737136 · Received October 23, 2009

    Report

    Report Number
    1720753-2009-07617
    Event Type
    Malfunction
    Date Received
    October 23, 2009
    Date of Event
    October 2, 2009
    Report Date
    October 16, 2009
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THERE WAS A NON GE X-RAY FOUND IN THE SYSTEM. THE REPORTED ISSUE IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9800 SYSTEM HAD A FILAMENT REGULATOR FAILURE ERROR MESSAGE AT BOOT UP. 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.

    Patients

    Seq Age Sex Outcome Treatment
    1