BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHILEY

    MDR report key: 1656767 · Received April 8, 2010

    Report

    Report Number
    2936999-2010-00582
    Event Type
    Death
    Date Received
    April 8, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 24, 2010
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CALLER STATED A PT WAS TRANSPORTED TO THE C.T. SUITE FROM ANOTHER FACILITY FOR SCANS. THE PT WAS TRACHED WITH A SIZE 8 UNK MODEL SHILEY TRACHEOSTOMY TUBE AND BEING VENTILATED 24/7 ON A VOLUME VENTILATOR. DURING THE TRANSPORT TO THE CT, THE PT WAS USING AN AMBU BAG AND 100% OXYGEN. THE TRIP TO RADIOLOGY WAS UNEVENTFUL. THE PT WAS MONITORED ON PULSE OXIMETRY AND MAINTAINED AN SPO2 98 TO 99. ON ARRIVAL IN THE CT SUITE, ALL VITAL SIGNS WERE STABLE AS FAR AS THE CALLER KNEW. STAFF PREPARED THE PT FOR A MOVE FROM THE TRANSPORT GURNEY TO THE CT TABLE. DURING THAT MOVE, THE TUBING FROM THE AMBU BAG CAUGHT IN THE SIDERAIL OF THE GURNEY AND THE TRACH BROKE. DUE TO THE BREAK, THE RESPIRATORY THERAPIST WAS NOT ABLE TO VENTILATE THE PT. AN ATTEMPT WAS MADE TO INSERT ANOTHER UNSPECIFIED TRACHEOSTOMY TUBE UNSUCCESSFULLY. THE PT VERY QUICKLY WENT INTO RESPIRATORY DISTRESS AND PROGRESSED TO RESPIRATORY AND CARDIAC ARREST AND THEN EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| R