BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAGONFLY

    MDR report key: 2822515 · Received October 23, 2012

    Report

    Report Number
    2822515
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 23, 2012
    Manufacturer
    NEUROVISION MEDICAL PRODUCTS, INC.
    Product Code
    ETN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DRAGONFLY ELECTRODE WAS ON A ENDOTRACHEAL TUBE. THE TUBE WAS USED TO INTUBATE THE PATIENT. IT IS USED FOR NERVE MONITORING. AS MD WAS STIMULATING USING THE MONOPOLAR ELECTRODE HE NOTICED THAT THE DRAGONFLY ELECTRODE WAS NOT PICKING UP THE STIMULUS TO THE NERVE. IT WAS WORKING ON EVERYTHING IT TOUCHED.I THEN CALLED THE COMPANY'S 800 NUMBER AND TALKED TO A SPECIALIST FROM THE COMPANY. AFTER WE TOLD HIM HOW WE HAD IT HOOKED UP AND HE DETERMINED WE HAD IT ALL SET UP THE WAY IT SHOULD BE, HE THEN TOLD US IT PROBABLY WAS THE DRAGONFLY ELECTRODE.HE THEN TOLD US IT WAS PROBABLY DEFECTIVE AND INSTRUCTED US IF POSSIBLE TO USE ANOTHER ELECTRODE. SURGEON ASKED ANESTHESIOLOGIST IF HE COULD REPLACE THE ET TUBE WITH ANOTHER TUBE WITH A NEW DRAGONFLY ELECTRODE ON IT. HE DID AND THE NEW ONE WORKED PERFECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAGONFLY ENDOTRACHEAL TUBE, ELECTRODE, NERVE MONITORING ETN NEUROVISION MEDICAL PRODUCTS, INC. LSE500MS 43712

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR