BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 880164 · Received July 15, 2007

    Report

    Report Number
    1720753-2007-03458
    Event Type
    Malfunction
    Date Received
    July 15, 2007
    Date of Event
    June 26, 2007
    Report Date
    July 15, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE OEC SERVICE REP INVESTIGATED THE ISSUE AND THE LIMITED INFO SHOWS PARTS WERE ORDERED TO RETURN SYS TO FUNCTIONALITY. UPDATED INFO, IF NECESSARY, WILL BE FORWARDED IN AN UPDATED REPORT. THIS ISSUE IS NOT NEW, AND IF SITUATION IS DIFFERENT THAN TYPICAL, AN UPDATE WILL BE ISSUED. THIS SYS IS ALSO NOT USED ON HUMAN PTS. THIS SYSTEM IS USED FOR RESEARCH AND DEVELOPMENT AT A MEDICAL DEVICE MFR. THE SYSTEM WAS TESTED, FOUND TO BE OPERATING AS INTENDED, AND RELEASED TO THE CUSTOMER FOR USE. THIS IS DATED 02 JULY 07.THE FACILITY WAS UNABLE TO, OR WOULD NOT PROVIDE ANY PT INFO WITH RESPECT TO THIS ISSUE. NO NEGATIVE PT EFFECTS WERE REPORTED BECAUSE OF THIS MALFUNCTION.

    Description of Event or Problem · 1

    THE GE OEC 9800 FLUOROSCOPY SYS DISPLAYED A COMMUNICATION ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. GE OEC 9800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR