BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NERVEANA

    MDR report key: 6232514 · Received January 9, 2017

    Report

    Report Number
    6232514
    Event Type
    Malfunction
    Date Received
    January 9, 2017
    Date of Event
    December 23, 2016
    Report Date
    December 29, 2016
    Manufacturer
    NEUROVISION MEDICAL PRODUCT, INC.
    Product Code
    GWF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS INTUBATED WITH THE NERVEANA ENDOTRACHEAL TUBE. THE TUBE WOULD NOT HOLD AIR WHEN INFLATED. THE TUBE WAS REMOVED AND PATIENT RE-INTUBATED WITH A NEW TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16348 NERVEANA STIMULATOR, ELECTRICAL GWF NEUROVISION MEDICAL PRODUCT, INC. NVTKIT-C8 083016A

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR