BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHAILEY TRACH 8DCT

    MDR report key: 418255 · Received September 19, 2002

    Report

    Report Number
    418255
    Event Type
    Injury
    Date Received
    September 19, 2002
    Date of Event
    September 17, 2002
    Report Date
    September 18, 2002
    Manufacturer
    MALLINCKRODT
    Product Code
    JOH
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VENT ALARM FOR LOW EXHALED MINUTE VOLUME AND LOW EXHALED TIDAL VOLUME. AUDIBLE CUFF LEAK, INABILITY BTO MAINTAIN PATENCY OF THE CUFF. THE PILOT BALLOON WAS PLACED IN WATER AND NOTED AIR BUBBLES ALONG THE HEAT SEAL EDGE OF THE BALLOON. PILOT BALLOON CRIMPED OFF AND NEW SHAILEY TRACH PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHAILEY TRACH 8DCT TRACH TUBE 8DCT JOH MALLINCKRODT * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L 603-881-5296