BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 3172255 · Received June 5, 2013

    Report

    Report Number
    1720753-2013-06750
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    February 5, 2013
    Report Date
    June 5, 2013
    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

    THE CUSTOMER WAS ABLE TO CLEAR THE PROBLEM THEMSELVES. NO SERVICE WAS REQUIRED.

    Description of Event or Problem · 1

    THE FIELD ENGINEER REPORTED THAT THE LEFT MONITOR WOULD INTERMITTENTLY LOSE 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
    249176 STENOSCOP FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) STENOSCOP

    Patients

    Seq Age Sex Outcome Treatment
    1