BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 3042336 · Received April 4, 2013

    Report

    Report Number
    1720753-2013-04610
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    February 27, 2013
    Report Date
    April 4, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. A REPLACEMENT INTERCONNECT CABLE WAS ORDERED FOR THE SYSTEM. THERE IS NO FURTHER REPAIR INFORMATION AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INTERMITTENT LOSS OF THE LIVE FLUOROSCOPIC IMAGE. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138503 STENOSCOP FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) STENOSCOP

    Patients

    Seq Age Sex Outcome Treatment
    1