BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV

    MDR report key: 2465953 · Received February 16, 2012

    Report

    Report Number
    2031702-2012-00056
    Event Type
    Death
    Date Received
    February 16, 2012
    Date of Event
    December 11, 2011
    Report Date
    February 16, 2012
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT PASSED AWAY WHILE CONNECTED TO THE VENTILATOR. THE PT HAD A MUCUS PLUG IN THE TRACH AND THE VENTILATOR BEGAN ALARMING. THE FAMILY DID NOT AMBU BAG WITH O2 AT THE PT TRACH BUT ATTEMPTED TO BAG THE PT BY MOUTH VIA THE MASK. THE PT HAD A CUFFED TRACH WHICH WAS NOT DEFLATED DURING BAGGING VIA MOUTH. THE DEALER STATED THE VENTILATOR PASSED GENERAL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LTV VENTILATOR, CONTINUOUS/CBK CBK CAREFUSION 203, INC. LTV 1150 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death