BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 6394573 · Received March 10, 2017

    Report

    Report Number
    6394573
    Event Type
    Malfunction
    Date Received
    March 10, 2017
    Date of Event
    January 26, 2017
    Report Date
    March 6, 2017
    Manufacturer
    NEUROVISION MEDICAL PRODUCTS INC.
    Product Code
    IKN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS PERFORMING A THYROIDECTOMY AND THE ELECTRODES ON THE ET MONITORING KIT WOULD NOT WORK. THIS OCCURRED AT THE BEGINNING OF THE CASE AFTER INDUCTION. NO HARM NOTED TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179009 NONE ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH IKN NEUROVISION MEDICAL PRODUCTS INC. NONE 010417D

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR