BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9600

    MDR report key: 1153683 · Received September 11, 2008

    Report

    Report Number
    1720753-2008-22302
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    May 12, 2008
    Report Date
    June 9, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE FILED WHEN ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9600 SYSTEM HAD NO IMAGE DURING A CASE. THE 9600 SYSTEM HAD TO BE REBOOTED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1