BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OCE 6600

    MDR report key: 861131 · Received June 6, 2007

    Report

    Report Number
    1720753-2007-01669
    Event Type
    Malfunction
    Date Received
    June 6, 2007
    Date of Event
    May 8, 2007
    Report Date
    June 6, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE FAILURE WAS VERIFIED AND THE VIDEO CONTROLLER CIRCUIT BOARD WAS REPLACED. 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 LIVE IMAGES WERE DISPLAYED AS ENTIRELY BLACK ON SCREEN ALTHOUGH CONTRAST AND OTHER MONITOR SETTINGS WERE NORMAL. THE 6600 SYSTEM WAS TRACKING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OCE 6600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR