BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULMONETIC

    MDR report key: 1040563 · Received May 9, 2008

    Report

    Report Number
    2031702-2008-00082
    Event Type
    Death
    Date Received
    May 9, 2008
    Date of Event
    December 15, 2007
    Report Date
    May 9, 2008
    Manufacturer
    CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K051767
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 THAT THE PT TRACH BECAME DISCONNECTED FROM THE VENTRICULAR WITHOUT ALARMING. THE PT WAS FOUND UNRESPONSIVE THE NEXT MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC LTV 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death