BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULMONETIC

    MDR report key: 1263147 · Received December 12, 2008

    Report

    Report Number
    2031702-2008-00228
    Event Type
    Death
    Date Received
    December 12, 2008
    Report Date
    December 12, 2008
    Manufacturer
    CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DIED. THERE WERE ALLEGATIONS OF VENTILATOR MALFUNCTION CAUSING PT HARM. IT IS UNK IF THE VENTILATOR ALARMED. THE DETAILS REGARDING THE VENTILATOR MALFUNCTION IS UNK AT THIS TIME.

    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