BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE, ENDOTRACHEAL

    MDR report key: 8101256 · Received November 26, 2018

    Report

    Report Number
    8101256
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Date of Event
    October 16, 2018
    Report Date
    November 16, 2018
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    LNZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE START, POST INTUBATION, OXYGEN SATURATIONS DECREASED BRIEFLY. TROUBLESHOOTING DONE. ADDITIONAL SUPPORT GIVEN AND OXYGEN LEVEL RETURNED THROUGHOUT PROCEDURE. UPON EXTUBATION, THE BALLOON ON ENDOTRACHEAL TUBE (ETT) WAS MALFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940833 TUBE, ENDOTRACHEAL LNZ MEDTRONIC XOMED, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 6570 DA