BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHILEY

    MDR report key: 2040784 · Received March 25, 2011

    Report

    Report Number
    2936999-2011-00217
    Event Type
    Death
    Date Received
    March 25, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 25, 2011
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN, THEREFORE, THE DATE OF MANUFACTURE CAN NOT BE DETERMINED. THE MODEL OF TRACHEOSTOMY TUBE IS UNKNOWN, THEREFORE, THE 510K CANNOT BE DETERMINED. PATIENT WAS ALSO USING A NELLCOR MODEL N-200 WHICH IS BEING FILED IN A SEPARATE REPORT: 2936999-2011-00165.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT IN REGARDS TO AN INCIDENT RESULTING IN A PATIENT DEATH. CUSTOMER STATED THE PATIENT WAS FOUND UNRESPONSIVE AT 5:30 AM ON (B)(6) 2011. THE PATIENT WAS USING A SHILEY SIZE 6 CUFFLESS DISPOSABLE TRACH THAT APPEARED TO HAVE AN OBSTRUCTION. THE PATIENT RECEIVED CPR AND THE AIR FROM THE AMBUBAG IN USE WENT TO THE PATIENT'S CHEEKS. THE PATIENT EXPIRED HALF AN HOUR LATER. THE MODEL NUMBER OF THE TUBE IS UNKNOWN, AND THE CALLER DOES NOT HAVE A LOT NUMBER OR EXPIRATION DATE. THE TUBE WAS DISPOSED OF. THE PATIENT HAD HAD THE TUBE SUCTIONED PREVIOUSLY WITHOUT INCIDENT. THE TUBE WAS NEVER EXAMINED FOR ANY OBSTRUCTION. THE CALLER STATED IT HAD BEEN IN USE FOR A FEW DAYS. THE PATIENT WAS IN AN ACUTE REHAB DEPARTMENT AND WAS CHECKED HOURLY. ON THE EVENING OF (B)(6), THE PATIENT WAS VERY RESTLESS AND HE PULLED HIS TRACHEOSTOMY TUBE OUT. THE PATIENT WAS TAKEN TO THE ER WHERE THE SAME TUBE WAS REINSERTED. THE PATIENT WAS SCOPED BY A PULMONOLOGIST WHICH REVEALED TRACHEAL SWELLING AND EDEMA. THAT EVENING, THE PATIENT DEVELOPED SUBCUTANEOUS EMPHYSEMA.

    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 75 YR Death NELLCOR MODEL N-200 PULSE OXIMETER