BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1140947 · Received September 3, 2008

    Report

    Report Number
    1720753-2008-24347
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    July 29, 2008
    Report Date
    August 6, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP ERASED THE NODES ON THE SYSTEM. HE REMOVED AND REPLACED THE GPOS 5197226 AND REPLACED WITH GPOS 00-886889-01, RELOADED SOFTWARE VER. 01. THE UNIT RUNS AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REQUESTED INSTALLATION OF THE CORRECT REVISION OF GPOS SINGLE BOARD COMPUTER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1