BEUDAMED
    FDA Adverse Event Death Summary report: N

    MALLINCKRODT

    MDR report key: 1068543 · Received June 18, 2008

    Report

    Report Number
    1068543
    Event Type
    Death
    Date Received
    June 18, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 21, 2008
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INTUBATION TUBE ETT CUFF DEFLATED CAUSING VENTILATOR ALARMS, LOW O2 SATURATIONS. SECRETIONS, COUGHING AND GURGLING. ATTEMPTS TO ADD AIR TO ETT CUFF WITHOUT SUCCESS. THE CUFF WAS NOT FUNCTIONING AND THE TUBE NEEDED TO BE CHANGED. SINCE THE PT WAS DNR, THE PT'S POA WAS CONTACTED FOR FURTHER GUIDANCE. THE POA DECIDED NOT TO HAVE THE PT REINTUBATED. THE PT WAS EXTUBATED, AND COMFORT MEASURES PUT INTO PLACE. UPON REMOVAL, A LARGE HOLE WAS NOTICED IN THE SIDE WALL OF THE CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT HI-LO EVAC INTUBATION TUBE 8.0MM BTR COVIDIEN HI-LO EVAC 0711200 1609

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death