BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 2820523 · Received November 2, 2012

    Report

    Report Number
    1720753-2012-09010
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 16, 2012
    Report Date
    November 2, 2012
    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

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE IDENTIFIED OR DUPLICATED. THE SYSTEM WAS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WENT INTO SAFETY MODE AND WOULD NOT DISPLAY A FLUOROSCOPY IMAGE. THERE IS NO REPORT OF PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1