BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUOROSCOPIC X-RAY

    MDR report key: 928238 · Received October 17, 2007

    Report

    Report Number
    1720753-2007-06690
    Event Type
    Malfunction
    Date Received
    October 17, 2007
    Date of Event
    September 26, 2007
    Report Date
    October 17, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE DESCRIBED FAILURE COULD NOT BE DUPLICATED. HOWEVER, IDENTIFIED THE NEED TO REPLACE THE FFD PCB BATTERY. REPLACED THE BATTERY. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SERVICE. FOLLOWING THE INITIAL INVESTIGATION, ADVISED FACILITY TO CONSIDER REPLACEMENT OF THE SINGLE BOARD COMPUTER (SBC) TO ADDRESS INTERMITTENT BOOT. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED AS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9800 SYSTEM DISPLAYED A COMMUNICATIONS ERROR AND HAD TO BE BOOTED SEVERAL TIMES (4X) & (2X) BEFORE THE ERROR WAS CLEARED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR