BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULMONETIC

    MDR report key: 1712823 · Received June 4, 2010

    Report

    Report Number
    2031702-2010-00105
    Event Type
    Death
    Date Received
    June 4, 2010
    Date of Event
    February 22, 2010
    Report Date
    June 4, 2010
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 VENTILATOR WAS ALARMING AND WOULD NOT SHUT OFF UNTIL PLUGGED IN. THERE ARE ALLEGATIONS THAT THE VENTILATOR MALFUNCTIONED CAUSING PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR/CBK CBK CAREFUSION 203, INC. LTV 950 C03495

    Patients

    Seq Age Sex Outcome Treatment
    1 21 MO Death