BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC XOMED

    MDR report key: 1077212 · Received July 7, 2008

    Report

    Report Number
    1077212
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 6, 2008
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING THYROID SURGERY. PHYSICIAN WANTED TO UTILIZE THE NIM MONITOR WHICH REQUIRES A SPECIAL INTUBATION TUBE. ANESTHESIOLOGIST INTUBATED PATIENT AND WAS NOT ABLE TO VENTILATE. THERE WERE NO SOUNDS OF AIR EXCHANGES WHILE HE LISTENED WITH THE STETHOSCOPE. THE ANESTHESIOLOGIST PULLED OUT THE TUBE AND PHYSICALLY EXAMINED IT. HE THEN TRIED TO REINTUBATE THE PATIENT, AND THE RESULT WAS THE SAME. THE TUBE WAS REMOVED AND A REGULAR INTUBATION TUBE WAS PLACED. THE PATIENT WAS VENTILATED WITHOUT ANY PROBLEM.====================== MANUFACTURER RESPONSE FOR NIM CONTACT EMG ENDOTRACHEAL TUBE, MEDTRONICE XOMED======================MANUFACTURER PROVIDED TRACKING NUMBER FOR RETURN EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC XOMED TUBE, ENDOTRACHEAL, NERVE MONITORING BTR MEDTRONIC XOMED, INC. 8229507 55076900

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR