BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 3823288 · Received March 20, 2014

    Report

    Report Number
    1720753-2014-02514
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 20, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE CONNECTIONS ON MEMORY CARD AND ACQUISITION CARD WERE EVALUATED AND RESEATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEFT MONITOR INTERMITTENTLY FAILED TO DISPLAY A FLUOROSCOPIC IMAGE. THIS ISSUE WILL CAUSE THE SYSTEM TO BE UNUSABLE DUE TO THE INABILITY TO SEE THE LIVE IMAGE. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167732 STENOSCOP FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) STENOSCOP

    Patients

    Seq Age Sex Outcome Treatment
    1