BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 2934123 · Received January 3, 2013

    Report

    Report Number
    1720753-2013-00070
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 3, 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

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFO WAS NOT REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HALF OF THE IMAGE WAS MISSING ON THE MONITORS AND THIS WAS PREVENTING THEIR WORK. THIS ISSUE COULD CAUSE THE SYSTEM TO BECOME UNUSABLE DUE TO THE INABILITY TO SEE THE LIVE IMAGE FROM THE TRUNCATE IMAGES. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3966 STENOSCOP FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) STENOSCOP

    Patients

    Seq Age Sex Outcome Treatment
    1