BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2833308 · Received October 26, 2012

    Report

    Report Number
    1720753-2012-08728
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 26, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE FOLLOWING SYSTEM COMPONENTS WERE RESEATED: THE GIB, FFB AND HV SUPPLY REGULATOR BOARDS AND THE CONNECTORS AND FUSES ON THE POWER SIGNAL INTERFACE BOARD. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE FIELD ENGINEER REPORTED THAT THE SYSTEM DISPLAYED COMMUNICATION FAILURE ERROR MESSAGES. THIS ERROR MESSAGE IS LIKELY TO RESULT IN A SYSTEM LOCK UP OR PREVENT THE SYSTEM FROM BOOTING TO A USABLE STATE. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1