BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULMONETIC

    MDR report key: 739936 · Received July 26, 2006

    Report

    Report Number
    2031702-2006-00175
    Event Type
    Death
    Date Received
    July 26, 2006
    Date of Event
    October 24, 2004
    Report Date
    July 25, 2006
    Manufacturer
    PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    PMA / PMN Number
    na
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE LTV MODEL, SERIAL, OR CATALOG NUMBER(S) ARE NOT KNOWN AT THIS TIME.

    Description of Event or Problem · 1

    MFR REC'D A REPORT OF A PT DEATH ON OR ABOUT 10/24/04. REPORTEDLY, THE "DECEDENT PASSED AWAY WHEN THE VENTILATOR, WHICH WAS REQUIRED TO SUSTAIN HER LIFE, WAS ALLOWED TO FAIL. IT WAS ALLEGED THE MFR FAILED TO MAKE CERTAIN THAT THE VENTILATOR WAS IN PROPER WORKING CONDITION AND THAT AN ALARM SYSTEM OR OTHER TYPE OF WARNING SYSTEM WAS IN EFFECT AND WORKING IN THE EVENT THAT THE VENTILATOR FAILED. AS A RESULT, THE PT BECAME COMATOSE AND BRAIN DEAD. SHE WAS UNABLE TO SURVIVE AND DIED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death