BEUDAMED
    FDA Adverse Event Death Summary report: N

    MALLINCKRODT

    MDR report key: 4939869 · Received July 24, 2015

    Report

    Report Number
    2936999-2015-00650
    Event Type
    Death
    Date Received
    July 24, 2015
    Date of Event
    June 10, 2015
    Report Date
    June 26, 2015
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    PMA / PMN Number
    K871204
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN HAS A PRODUCT (LASER FLEX) DESIGNED FOR THE PURPOSE OF USE WITH LASERS TO PREVENT AIRWAY FIRES. THE PRODUCT ASSOCIATED WITH THIS REPORT WAS MANUFACTURED APRIL 18, 1996. A LETTER DATED 1/24/2008 WAS SENT TO CUSTOMERS IN REFERENCE TO EXPIRATION DATES FOR MALLINCKRODT ENDOTRACHEAL TUBES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A YAG LASER BRONCHOSCOPY PROCEDURE ON (B)(6) 2015, AN AIRWAY FIRE OCCURRED. THE CUSTOMER WAS USING A 9.5LO-PRO CUFFED ENDOTRACHEAL TUBE WITH MURPHY EYE, DURING THE PROCEDURE. WHEN THE AIRWAY FIRE OCCURRED, THE PROCEDURE WAS STOPPED AND THE OXYGEN TURNED OFF. TREATMENT WAS TO "FLOOD WITH ICE COLD WATER' AND THE PATIENT WAS REINTUBATED AND TAKEN TO ANOTHER HOSPITAL FOR BURN TREATMENT. THE PATIENT SUBSEQUENTLY EXPIRED ON (B)(6) 2015. ATTEMPTS TO OBTAIN THE AFFECTED SAMPLE AND/OR PHOTOS HAVE BEEN UNSUCCESSFUL AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482786 MALLINCKRODT TRACHEAL TUBE BTR COVIDIEN 86056 MK12850

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death