BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1014285 · Received March 12, 2008

    Report

    Report Number
    1720753-2008-17928
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 11, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. REPLACED THE FLUORO FUNCTION BOARD, GENERATOR INTERFACE BOARD AND THE SYSTEM INTERFACE. RELOADED ALL SOFTWARE AND CAL FILES. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SIDE PANEL DISPLAY ON THE 9900 SYSTEM IS SHOWING SQUARES (ACTING LIKE IT IS FLUOROING BUT IT IS NOT). THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1