BEUDAMED
    FDA Adverse Event Death Summary report: N

    DISPOSABLE CANNULA LOW PRESSURE TRACH TUBE

    MDR report key: 31471 · Received February 20, 1996

    Report

    Report Number
    31471
    Event Type
    Death
    Date Received
    February 20, 1996
    Date of Event
    February 12, 1996
    Report Date
    February 20, 1996
    Manufacturer
    MALLINCKRODT MEDICAL TPI, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT 2:15 AM, IT WAS DISCOVERED THAT THE RESIDENT WAS UNRESPONSIVE AND HAD NO VITAL SIGNS. IT WAS NOTED IN THE NURSES NOTES THAT HIS INNER CANNULA WAS LYING ON HIS CHEST AND ATTACHED TO THE VENT CIRCUIT. THE VENT ALARM WAS IN THE ON POSITION BUT THE ALARM DID NOT SOUND WHEN THE INNER CANNULA CAME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE CANNULA LOW PRESSURE TRACH TUBE TRACH TUBE BTO MALLINCKRODT MEDICAL TPI, INC. 8DCT

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death