BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1140944 · Received September 3, 2008

    Report

    Report Number
    1720753-2008-24344
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    July 28, 2008
    Report Date
    August 6, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REQUESTED THE SBC UPGRADE TO REMEDY COMMUNICATION ERROR. WE REPLACED THE SBC AND TESTED THE SYSTEM BY MAKING X-RAYS AND BOOTED THE SYSTEM MULTIPLE TIMES. SYSTEM IS WORKING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WAS REPORTING A COMMUNICATION ERROR. THE SYSTEM HAS AN OLD SBC. WE RECOMMENDED THAT THE SYSTEM BE UPGRADED TO ENSURE NO OLD PROCESSOR ISSUES.

    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