BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 3101757 · Received April 30, 2013

    Report

    Report Number
    1720753-2013-05502
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM BUT NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD INTERMITTENTLY NOT PRODUCE X-RAYS. THIS COULD CAUSE THE SYSTEM TO INTERMITTENTLY BECOME UNSTABLE DUE TO THE INABILITY TO PRODUCE A 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
    187067 STENOSCOP FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) STENOSCOP

    Patients

    Seq Age Sex Outcome Treatment
    1