BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC STENOSCOPE

    MDR report key: 1083743 · Received July 29, 2008

    Report

    Report Number
    9617766-2008-01229
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 28, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE HIGH VOLTAGE CONNECTOR WAS TIGHTENED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENOSCOPE SYSTEM HAD LINES IN THE IMAGES. 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