BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN

    MDR report key: 16655761 · Received March 31, 2023

    Report

    Report Number
    16655761
    Event Type
    Malfunction
    Date Received
    March 31, 2023
    Date of Event
    March 2, 2023
    Report Date
    March 10, 2023
    Manufacturer
    MEDTRONIC INC.
    Product Code
    LNZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PILOT BALLOON THAT IS A PART OF THE ENDOTRACHEAL TUBE HAD FAILED TO RETAIN INFLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580270 COVIDIEN ENDOTRACHEAL TUBE LNZ MEDTRONIC INC. NOT DOCUMENTED NOT DOCUMENTED

    Patients

    Seq Age Sex Outcome Treatment
    1 730 DA Male