BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULMONETIC

    MDR report key: 1321027 · Received February 19, 2009

    Report

    Report Number
    2031702-2009-00027
    Event Type
    Death
    Date Received
    February 19, 2009
    Date of Event
    September 5, 2008
    Report Date
    February 18, 2009
    Manufacturer
    CARDINAL HEALTH 203 / PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2008, THE PT DESATURATED AND THEN WENT INTO CARDIAC ARREST FOR 20 MINUTES WHILE ON THE VENTILATOR (THE CAUSE IS UNKNOWN). THREE DAYS LATER, THE FATHER REPORTED TO HOME HEALTH CARE AGENCY THAT THE PT HAD SEVERE BRAIN DAMAGE. THE PT WAS REMOVED FROM THE VENTILATOR AND PLACED ON THE HOSPITAL EQUIPMENT UNTIL THE PARENTS CANCELLED THE LIFE SUPPORT AND THE PT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK CARDINAL HEALTH 203 / PULMONETIC SYSTEMS, INC. LTV 950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Death