BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 3182556 · Received June 14, 2013

    Report

    Report Number
    1720753-2013-07105
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    April 3, 2013
    Report Date
    June 14, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS DECIDED NOT TO REPAIR THE SYSTEM AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT BOTH MONITORS SHUT OFF DURING A PROCEDURE. THIS RESULTED IN A LOSS OF THE LIVE IMAGE. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272273 STENOSCOP FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) STENOSCOP

    Patients

    Seq Age Sex Outcome Treatment
    1