BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV

    MDR report key: 3052539 · Received April 3, 2013

    Report

    Report Number
    2031702-2013-00066
    Event Type
    Death
    Date Received
    April 3, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 3, 2013
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT PASSED AWAY WHILE CONNECTED TO THE VENTILATOR. THE PT DEATH IS CURRENTLY UNDER POLICE INVESTIGATION. THE DETAILS REGARDING THE PT DEATH ARE LIMITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135548 LTV VENTILATOR, CONTINUOUS/CBK CBK CAREFUSION 203, INC LTV 950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 MO Death