BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 2892698 · Received December 27, 2012

    Report

    Report Number
    1720753-2012-10811
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    December 7, 2012
    Report Date
    December 27, 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 REP EVALUATED THE SYS AND FOUND A CABLE NEEDED TO BE REPLACED AND PROVIDED THE CUSTOMER A REPAIR QUOTE, BUT NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM TURNS ON, BUT DOES NOT DISPLAY AN IMAGE. THE FIELD ENGINEER NOTED THAT IT WAS AN INTERMITTENT ISSUE. THIS ISSUE WILL CAUSE THE SYSTEM TO BE UNUSABLE DUE TO THE INABILITY TO SEE THE LIVE IMAGE. 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
    1 STENOSCOP FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) STENOSCOP

    Patients

    Seq Age Sex Outcome Treatment
    1