BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC STENOSCOPE

    MDR report key: 1152404 · Received September 10, 2008

    Report

    Report Number
    9617766-2008-01164
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 13, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THIS PRODUCT IS END OF LIFE AND THE PARTS ARE NO LONGER AVAILABLE FOR THE SYSTEM. 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 STENOSCOPE SYSTEM LOCKED UP DURING A CASE. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1