BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NERVE¿NA RLN MONITORING KIT WITH COBRA

    MDR report key: 4580214 · Received February 26, 2015

    Report

    Report Number
    4580214
    Event Type
    Malfunction
    Date Received
    February 26, 2015
    Date of Event
    February 5, 2015
    Report Date
    February 26, 2015
    Manufacturer
    NEUROVISION MEDICAL PRODUCTS, INC.
    Product Code
    ETN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ANETHESIOLOGIST REPORTED WHEN THE ENDOTRACHEAL TUBE WAS INSERTED, A LEAK WAS NOTED, THE TUBE WAS REMOVED AND DISCOVERED THAT IT WAS RUPTURED, HE PUT THE TUBE IN A CUP OF WATER AND INFLATED THE BALLOON WITH LEAKING NOTED FROM WHERE THE BALLOON ATTACHES TO THE TUBE.======================MANUFACTURER RESPONSE FOR ENDOTRACHEAL TUBE WITH NERVE MONITORING, COBRA ET TUVE ELECTRODE PRODUCT - NERVEANA THYROIDECTOMY PARTHYRIODECTOMY ENDO TRACHEAL TUBE (PER SITE REPORTER).======================THE OR HAS BEEN IN CONTACT WITH THE QUALITY MANAGER AT NEUROVISION,(B)(6), DIRECTOR OF REGULATORY AFFAIRS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137370 NERVE¿NA RLN MONITORING KIT WITH COBRA STIMULATOR, NERVE ETN NEUROVISION MEDICAL PRODUCTS, INC. * 010915A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR