BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE STENOSCOPE

    MDR report key: 1113006 · Received August 15, 2008

    Report

    Report Number
    9617766-2008-01098
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 24, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENOSCOPE SYSTEM HAD A DATA BASE ERROR MESSAGE DISPLAYED. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1