BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO TRACHEAL TUBE, 6MM, EMG CONTACT

    MDR report key: 2052198 · Received April 12, 2011

    Report

    Report Number
    1045254-2011-00023
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 17, 2011
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE ANESTHESIOLOGIST REPORTED THAT WHILE USING THE 6MM NIM EMG ET TUBE IN THE O.R., THEY WERE: "NOT ABLE TO VENTILATE, BREATHE AIRWAY" OF THE PATIENT. THE PATIENT HAD DIFFICULTY BREATHING. THE EMG TUBE WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED. THE ANESTHESIOLOGIST ALSO REPORTED THAT POST-OPERATIVELY, THE PATIENT HAD A SORE THROAT BUT WAS OTHERWISE FINE. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER REGARDING PATIENT INFORMATION AND RETURN OF THE PRODUCT IN QUESTION. ANY MISSING OR INCOMPLETE DATA FROM FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED BY THE REPORTER DESPITE DOCUMENTED ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION. THIS PRODUCT IS USED FOR TREATMENT AND NOT FOR DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO TRACHEAL TUBE, 6MM, EMG CONTACT STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8229506 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1