BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1178236 · Received September 30, 2008

    Report

    Report Number
    1720753-2008-22497
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 12, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP TROUBLESHOOT THE SYSTEM AND WAS NOT ABLE TO DUPLICATE WHAT THE TECH WAS REPORTING. HE DID FIND THAT THE SYSTEM NEED AN SBC UPGRADE. HE ORDERED PARTS FOR THE UPGRADE AND PERFORMED THE UPGRADE ON THE SYSTEM. THERE WAS A PROBLEM, THE SYSTEM IS FAIRLY OLD AND BECAUSE OF THIS, IT HAD AN X-RAY CONTROLLER, THE COMPANY SINCE THEN HAVE UPGRADED TO THE GENERATOR INTERFACE BOARD. THE SBC UPGRADE KIT DID NOT COME WITH THAT PARTICULAR BOARD. HE ALSO ORDERED AN UPDATED IMAGE PROCESSOR BOARD. HE GOT THE BOARDS AND INSTALLED THE GENERATOR INTERFACE BOARD AND THE IMAGE PROCESSOR BOARD. HE ALSO REFLASHED THE NODES AND PERFORM A SOFTWARE UPGRADE ON THE TO BRING IN CURRENT WITH THE LATEST REVISION OF SOFTWARE. REBOOTED THE SYSTEM. SYSTEM CAME BACK UP AND WAS PRODUCING AN IMAGE IN THE SCREEN. SYSTEM IS WORKING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DOCTOR WAS FLUOROING THEN THE SYSTEM STOPPED PRODUCING AN IMAGE ON THE LEFT MONITOR. NO PATIENT INJURIES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1