BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9900

    MDR report key: 1181823 · Received September 19, 2008

    Report

    Report Number
    1720753-2008-26061
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 19, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED. THE HIGH VOLTAGE CABLE WAS CLEANED AND RE-GREASED. THE FILAMENT WAS CALIBRATED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE X-RAY TUBE ON THE 9900 SYSTEM WAS ARCING. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1