BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE STENOSCOPE

    MDR report key: 1052374 · Received April 30, 2008

    Report

    Report Number
    9617766-2008-01101
    Event Type
    Malfunction
    Date Received
    April 30, 2008
    Date of Event
    April 18, 2008
    Report Date
    April 28, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENOSCOPE SYSTEM MADE A LOAD POPPING NOISE THEN NOTHING WORKED. NO PATIENT 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