BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM CONTACT

    MDR report key: 7107922 · Received December 12, 2017

    Report

    Report Number
    7107922
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    September 28, 2017
    Report Date
    November 2, 2017
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    BXN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS BROUGHT TO THE OPERATING ROOM AND READIED FOR INTUBATION. PATIENT WAS INTUBATED BY DOCTOR USING THE NIM CONTACT EMG ENDOTRACHEAL TUBE (ETT) SIZE 8 WITHOUT PROBLEM. WHEN THE DOCTOR WENT TO INFLATE THE ETT CUFF, THE INFLATION TUBING CAME OFF IN HIS HAND AND HE WAS UNABLE TO INFLATE THE CUFF. THE DOCTOR THEN UTILIZED AN INTRODUCER (BOUGIE) AND REMOVED THE DEFECTIVE ETT, AND REPLACED IT WITH ANOTHER NIM CONTACT EMG ETT SIZE 8. THE CUFF WAS EASILY INFLATED AND THE CASE PROCEEDED WITHOUT FURTHER PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887851 NIM CONTACT STIMULATOR, NERVE BXN MEDTRONIC XOMED, INC. 8229508 0210050657

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR