BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULMONETIC

    MDR report key: 1059194 · Received June 10, 2008

    Report

    Report Number
    2031702-2008-00107
    Event Type
    Death
    Date Received
    June 10, 2008
    Date of Event
    April 20, 2006
    Report Date
    June 10, 2008
    Manufacturer
    CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED ON MAY 12, 2008, THAT THE PT DIED WHILE ON THE VENTILATOR. WHEN THE PT WAS FOUND, THE VENTILATOR ALLEGEDLY DID NOT AUDIBLY ALARM ALERTING THE NURSE THAT THE TRACH TUBE WAS LOOSE.

    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 Death