BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 1011857 · Received March 11, 2008

    Report

    Report Number
    9617766-2008-00127
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 7, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS 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 REP PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. REPLACED THE INTERCONNECT CABLE. 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 HIGH VOLTAGE CABLE ON THE STENOSCOP SYSTEM C-ARM CRACKED. IT WAS NOTED THAT THE UNIT IS FUNCTIONAL, BUT THE CABLE NEEDS REPLACEMENT. THERE WAS NO REPORT OF PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1