BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULMONETIC

    MDR report key: 1657149 · Received April 8, 2010

    Report

    Report Number
    2031702-2010-00060
    Event Type
    Death
    Date Received
    April 8, 2010
    Date of Event
    January 17, 2010
    Report Date
    April 8, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A MUCUS PLUG WHILE CONNECTED TO THE VENTILATOR, BUT THE VENTILATOR DID NOT ALARM. THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK CAREFUSION 203, INC. LTV 900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 MO Death