BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM EMG ENDOTRACHEAL TUBE

    MDR report key: 2223918 · Received August 15, 2011

    Report

    Report Number
    2223918
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 15, 2011
    Manufacturer
    MEDTRONIC XOMED, 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 MEDTRONIC NIM ENDOTRACHEAL TUBE (ET) WAS USED TO INTUBATE THE PATIENT. THE ET TUBE FAILED TO WORK WITH THE NIM MONITOR SYSTEM. WE SWITCHED ET TUBES AND THE NEW TUBE WORKED.IN ORDER TO SWITCH TUBES THE PATIENT HAD TO BE EXTUBATED AND A NEW TUBE WAS INSERTED.====================== MANUFACTURER RESPONSE FOR NIM ETT, NIM CONTACT ENDOTRACHEAL TUBE (PER SITE REPORTER)======================THE MANUFACTURER IS REQUESTING RETURN OF THE DEVICE AFTER BEING PROCESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIM EMG ENDOTRACHEAL TUBE TUBE, TRACHEAL (W/WO CONNECTOR) ETN MEDTRONIC XOMED, INC. 8229506 0205271416

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR NONE KNOWN