BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA 2 CHANNEL EMG ET TUBE

    MDR report key: 3876162 · Received June 5, 2014

    Report

    Report Number
    3876162
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    March 14, 2014
    Report Date
    June 3, 2014
    Manufacturer
    NEUROVISION MEDICAL PRODUCTS, INC.
    Product Code
    ETN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    TRIAL NEUROVISION COBRA 7MM ET TUBE WAS PLACED IN PATIENT AND BALLOON CUFF WAS INFLATED. A LEAK WAS NOTICED AT THE CUFF, MORE AIR WAS ADDED TO BALLOON CUFF, BUT IT CONTINUED TO LEAK. TUBE WAS REPLACED AND SAVED TO SEND FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328555 COBRA 2 CHANNEL EMG ET TUBE STIMULATOR, NERVE ETN NEUROVISION MEDICAL PRODUCTS, INC. 7MM 02514D

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR