BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA

    MDR report key: 12306800 · Received August 11, 2021

    Report

    Report Number
    12306800
    Event Type
    Malfunction
    Date Received
    August 11, 2021
    Date of Event
    July 14, 2021
    Report Date
    July 26, 2021
    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

    7.0 NIM TUBE WITH BLUE AND RED CORDS NOT IN NORMAL ORIENTATION ON ET TUBE. RIGHT SIDE MONITORING NOT EXISTENT DURING ENTIRE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205578 COBRA TUBE, TRACHEAL (W/WO CONNECTOR) BTR NEUROVISION MEDICAL PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 13140 DA