BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 2850263 · Received November 26, 2012

    Report

    Report Number
    1720753-2012-09603
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 26, 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 REP PERFORMED AN ONSITE INVESTIGATION. NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FOOT PEDAL WAS STUCK IN THE ON POSITION WHEN THE SYSTEM WAS TURNED ON AND PRODUCED UNCOMMANDED X-RAYS. 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