BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9600

    MDR report key: 1030878 · Received April 17, 2008

    Report

    Report Number
    1720753-2008-20589
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 31, 2008
    Report Date
    April 11, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE TUBE WAS REPLACED BY A THIRD PARTY. 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 ARCING FROM THE TUBE. ALSO, THERE WAS TEMPERATURE SENSOR, PRECHARGE, AND CHANNEL FAILURE ERROR MESSAGE. 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