BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 2941156 · Received January 31, 2013

    Report

    Report Number
    1720753-2013-01310
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    October 12, 2012
    Report Date
    January 31, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE VIDEO AND POWER SUPPLY CABLES, ALONG WITH ALL ASSOCIATED CONNECTORS, WERE RESEATED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS NOT EXPOSING. THE FIELD ENGINEER DETERMINED THAT THE LEFT MONITOR WAS NOT WORKING, RESULTING IN A LOSS OF THE LIVE IMAGE. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43599 STENOSCOP FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) STENOSCOP

    Patients

    Seq Age Sex Outcome Treatment
    1