BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULMONETIC

    MDR report key: 1600971 · Received February 11, 2010

    Report

    Report Number
    2031702-2010-00010
    Event Type
    Death
    Date Received
    February 11, 2010
    Report Date
    January 29, 2010
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B) (6) 2007, THE VENTILATOR ALLEGEDLY FAILED TO ALARM WHEN PATIENT'S TRACH ALLEGEDLY BECAME DISLODGED AND/OR HIS HEART RATE AND/OR O2 LEVEL ALLEGEDLY DROPPED. THE PATIENT ALLEGEDLY SUSTAINED SEVERE BRAIN DAMAGE AND PASSED AWAY ON (B) (6) 2007.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death