BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV

    MDR report key: 2481182 · Received March 1, 2012

    Report

    Report Number
    2031702-2012-00066
    Event Type
    Death
    Date Received
    March 1, 2012
    Date of Event
    January 11, 2012
    Report Date
    March 1, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED PROBLEM WAS ORIGINALLY REPORTED BY THE PT'S MOTHER. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD STOPPED BREATHING AND PASSED AWAY WHILE CONNECTED TO THE VENTILATOR. THE VENTILATOR DID NOT ALARM FOR APNEA. THE PT USES THE VENTILATOR NON-INVASIVELY WITH A MASK

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LTV VENTILATOR, CONTINUOUS / CBK CBK CAREFUSION 203, INC. LTV 950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death