BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 3210150 · Received July 3, 2013

    Report

    Report Number
    1720753-2013-07841
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 24, 2013
    Report Date
    July 3, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CANCELLED THE SERVICE CALL AND ENGAGED A THIRD PARTY SERVICE PROVIDER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY COULD NOT SELECT A SYSTEM SET-UP, AND THEY COULDN'T SHUT DOWN THE SYSTEM EITHER. THE SYSTEM WAS LOCKED UP. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306319 STENOSCOP FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS STENOSCOP

    Patients

    Seq Age Sex Outcome Treatment
    1