BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7MM NEUROVISION COBRA ET TUBE

    MDR report key: 5895961 · Received August 23, 2016

    Report

    Report Number
    5895961
    Event Type
    Malfunction
    Date Received
    August 23, 2016
    Date of Event
    August 4, 2016
    Report Date
    August 16, 2016
    Manufacturer
    NEUROVISION MEDICAL PRODUCTS INC
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS INTUBATED WITH A COBRA 2-CHANNEL 7.0MM ENDOTRACHEAL TUBE LOT # 071416C, EXP. DATE 01/31/2019. NO READING COULD BE OBTAINED ON THE NIM MONITOR, A NEW MONITOR WAS BROUGHT IN WITH THE SAME RESULT. TUBE WAS DETERMINED TO BE DEFECTIVE. PATIENT WAS REINTUBATED WITH ANOTHER TUBE. MANUFACTURER RESPONSE FOR ENDOTRACHEAL TUBE, NEUROVISION ETT (PER SITE REPORTER): UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548667 7MM NEUROVISION COBRA ET TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR NEUROVISION MEDICAL PRODUCTS INC 071416C

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR