BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 2954106 · Received November 15, 2007

    Report

    Report Number
    9617766-2007-00341
    Event Type
    Malfunction
    Date Received
    November 15, 2007
    Date of Event
    October 22, 2007
    Report Date
    November 14, 2007
    Manufacturer
    GE OBC MEDICAL SYSTEM INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION COULD NOT BE REPRODUCED NOR BE VERIFIED. THE MONITOR HANDLES WERE FOUND TO BE BROKEN BUT WERE UNRELATED TOT HE ORIGINAL COMPLAINT. THE HANDLES WERE REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENOSCOP SYSTEM HAD TROUBLE INITIALIZING AND THAT THE INTERCONNECT CABLE WAS PRESENTING DIFFICULTY CONNECTING TO THE SYSTEM. THESE PROBLEMS CREATED DELAY. THERE WAS NO ADVERSE PT INVOLVEMENT REPORTED. THERE WAS NO PT INFO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STENOSCOP FLUOROSCOPIC X-RAY JAA GE OBC MEDICAL SYSTEM INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1