BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA

    MDR report key: 9859575 · Received March 20, 2020

    Report

    Report Number
    9859575
    Event Type
    Malfunction
    Date Received
    March 20, 2020
    Date of Event
    February 13, 2020
    Report Date
    February 13, 2020
    Manufacturer
    NEUROVISION MEDICAL PRODUCTS, INC.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER INTUBATION, SURGEON NOTED THAT THE NIM TUBING WAS NOT CONNECTING TO NIM MACHINE. INFORMED CRNA AND CALLED ANESTHESIOLOGIST TO RESOLVE ISSUES. NOTED BLUE ELECTRODE FROM NIM TUBE FAILED TO BE RECOGNIZED BY THE MACHINE. ANESTHESIOLOGIST REPLACED NIM TUBE RIGHT AWAY AND SOLVED THE ISSUES. FAILED NIM TUBE REPORTED DEFECTS TO MANUFACTURER AND SENT REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321742 COBRA TUBE, TRACHEAL (W/WO CONNECTOR) BTR NEUROVISION MEDICAL PRODUCTS, INC. C090319

    Patients

    Seq Age Sex Outcome Treatment
    1