BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1070815 · Received July 9, 2008

    Report

    Report Number
    1720753-2008-22844
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 24, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS OPENED IN CONJUNCTION WITH INSTALLATION. DURING THE INSTALLATION, THE REP NOTICED THAT THE SYSTEM WAS INTERMITTENTLY LOCKING UP DURING BOOT. THE GPOS WAS NOT BOOTING COMPLETELY. RESEATED ALL THE BOARDS AND FUSES ON THE BACKPLANE. NO GO. HE ORDERED SOFTWARE. HE COMPLETED A CLEAN SOFTWARE RELOAD. TESTED BY BOOTING THE SYSTEM 10 TIMES. THE UNIT BOOTED SEVERAL TIMES, BUT NOW IS DOWN HARD AND THE GPOS WILL NOT BOOT AT ALL. HE ORDERED A NEW GPOS AND REPLACED GPOS THEN PERFORMED A CLEAN SOFTWARE INSTALL. UNIT NOW BOOTS. TESTED BY BOOTING UNIT 10 TIMES WITH NO PROBLEMS. UNIT IS FUNCTIONING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INTERMITTENT BOOT-UP PROBLEMS.

    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