BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 1071191 · Received July 10, 2008

    Report

    Report Number
    1720753-2008-22959
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 26, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP FOUND UNIT FROZE IN THE TIME AND DATE SCREEN. HE RESET THE WORKSTATION BOARDS AND ADJUSTED THE 5V POWER SUPPLY. HE ALSO NOTICED THE UNIT HAD OLDER STYLE CPU BOARD AND ADVISED CUSTOMER THE BOARD COULD BE CAUSING THE INTERMITTENT "NO COMMINICATION WITH WORKSTATION" ERROR MESSAGE AND THAT IT MIGHT HAVE TO BE CHANGED. AFTER RESEATING THE BOARD, THE SYSTEM WORKED FINE. THE REP CHECKED THE SYSTEM AND THE UNIT IS WORKING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNIT WAS NOT COMMUNICATING WITH WORKSTATION. THE SYSTEM IS FREEZING AFTER REBOOT AND THEY CANNOT FLUORO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1