BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULMONETIC

    MDR report key: 951049 · Received November 23, 2007

    Report

    Report Number
    2031702-2007-00201
    Event Type
    Death
    Date Received
    November 23, 2007
    Date of Event
    October 18, 2007
    Report Date
    November 21, 2007
    Manufacturer
    PULMONETIC SYSTEMS, INC., CARDINAL HEALTH 203
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CHILD WITH HISTORY OF SELF DECANNULATION FOUND UNRESPONSIVE, DECANNULATED. CAREGIVER STATED VENTILATOR AND PULSE OXIMETER DID NOT ALARM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death