BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEC 9800

    MDR report key: 1003912 · Received January 28, 2008

    Report

    Report Number
    1003912
    Event Type
    Malfunction
    Date Received
    January 28, 2008
    Date of Event
    March 27, 2006
    Report Date
    April 13, 2007
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    X-RAY MACHINE MALFUNCTION. THE MACHINE WAS NOT SAVING RUNS. IT IS NOT KNOWN IF ANY ERROR MESSAGES WERE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OEC 9800 X-RAY SYSTEM, C-ARM, PORTABLE JAA GE MEDICAL SYSTEMS, LLC 9800 *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR