BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NERVEANA EMG ET TUBE 7MM

    MDR report key: 7685079 · Received July 13, 2018

    Report

    Report Number
    7685079
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    June 26, 2018
    Report Date
    July 5, 2018
    Manufacturer
    NEUROVISION MEDICAL PRODUCTS, INC.
    Product Code
    ETN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS INTUBATED WITH A NERVEANA 7 MM ETT FOR NEURO-MONITORING DURING SURGERY. THE NEURO-MONITORING PORTION OF THE ETT STOPPED WORKING. WHEN THE PATIENT WAS EXTUBATED AT THE END OF THE CASE, NEURO-MONITOR REP NOTICED THAT THE RED ELECTRODE PORTION OF THE TUBE WAS FRAYED INSIDE THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529866 NERVEANA EMG ET TUBE 7MM NEURO-MONITORING ELECTRODE ETN NEUROVISION MEDICAL PRODUCTS, INC. NVTKIT-C7 011818

    Patients

    Seq Age Sex Outcome Treatment
    1 19345 DA