BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 1743119 · Received June 28, 2010

    Report

    Report Number
    2936999-2010-00944
    Event Type
    Death
    Date Received
    June 28, 2010
    Date of Event
    May 26, 2010
    Report Date
    June 9, 2010
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ANALYSIS OR CONCLUSIONS CAN BE MADE WITH OUT THE DEVICE AND LOT NUMBER.

    Description of Event or Problem · 1

    A COPY OF A VENDOR QUALITY REPORT FROM THE CUSTOMER WAS RECEIVED ON 06/09/2010. THE REPORT IS DATED 06/04/2010. THE PRODUCT BEING REPORTED IS A 6DCT. ACCORDING TO THE REPORT, THE CUSTOMER RECEIVED PRODUCT ON (B) (6) 2009 AND ON (B) (6) 2010. THE DATE OF THE INCIDENT WAS 05/26/2010. THE REPORT STATES AS FOLLOWS: THE PATIENT DISCONNECTED FROM A HOME VENTILATOR; WHEN THE PARENT RECONNECTED THE VENTILATOR, IT STOPPED ALARMING BUT THE PT WAS NOT RESPONSIVE; PARAMEDICS AND HOSPITAL STAFF UNABLE TO INFLATE TRACHEOSTOMY TUBE CUFF; THE MOTHER OF THE PATIENT STATED THAT THE PATIENT NEVER INFLATED THE CUFF BECAUSE HE COULD NOT TALK THAT WAY. A COVIDIEN TECHNICAL SPECIALIST CONTACTED THE CUSTOMER AND IN CONVERSATION THE CUSTOMER REP FURTHER STATED THAT THE CUFF WOULD NOT INFLATE. THE TRACHEOSTOMY TUBE WAS NOT SAVED AND THEY DO NOT HAVE A LOT NUMBER. THE REP DID NOT KNOW WHAT MODEL OF VENTILATOR WAS BEING USED. THE PATIENT WAS A (B) (6) MALE WHO EXPIRED. THE REP HAD NO FURTHER INFO TO PROVIDE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death| R