BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA EMG ET TUBE

    MDR report key: 8734113 · Received June 26, 2019

    Report

    Report Number
    8734113
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    February 11, 2019
    Report Date
    June 11, 2019
    Manufacturer
    NEUROVISION MEDICAL PRODUCTS INC
    Product Code
    ETN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NEURO MONITORING PERSON, INFORMED THE WHOLE TEAM, THAT THERE IS SOMETHING WRONG IN THE ET TUBE. DIFFICULTY IN READING THE MONITOR. HOWEVER, ON THE ANESTHESIA SIDE THERE IS NO PROBLEM. THE NEURO MONITOR PERSON GAVE THIS NOTICE AT CLOSE OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530418 COBRA EMG ET TUBE STIMULATOR, NERVE ETN NEUROVISION MEDICAL PRODUCTS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 12045 DA