BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE OEC 9800

    MDR report key: 768757 · Received October 11, 2006

    Report

    Report Number
    1720753-2006-00073
    Event Type
    Injury
    Date Received
    October 11, 2006
    Date of Event
    September 13, 2006
    Report Date
    October 11, 2006
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9800 SYSTEM LOCKED UP DURING AN ENDOVASCULAR CASE. THE 9800 SYSTEM COULD NOT BE REBOOTED AND HAD TO BE REMOVED. ANOTHER 9800 SYSTEM WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD A THROMBOSIS. THE EVENT WAS REPORTED TO THE ANOTHER COUNTRY REGULATORY AGENCY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other