BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV

    MDR report key: 2574576 · Received May 9, 2012

    Report

    Report Number
    2031702-2012-00122
    Event Type
    Death
    Date Received
    May 9, 2012
    Date of Event
    April 7, 2012
    Report Date
    May 8, 2012
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 VENTILATOR DID NOT ALARM. THE PT WAS ON A FLEX TUBE WHICH WAS KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LTV VENTILATOR, CONTINUOUS/CBK CBK CAREFUSION 203, INC. LTV 1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death