BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 3113086 · Received May 9, 2013

    Report

    Report Number
    1720753-2013-05850
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    February 13, 2013
    Report Date
    May 9, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE COMMUNICATION CABLE WAS REPLACED AND THE SYSTEM SOFTWARE WAS RELOADED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED AN ERROR MESSAGE AND WAS DOWN. THE SYSTEM WAS RENDERED INOPERABLE. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202708 STENOSCOP FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) STENOSCOP

    Patients

    Seq Age Sex Outcome Treatment
    1