BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULMONETIC

    MDR report key: 1590127 · Received January 26, 2010

    Report

    Report Number
    MW5014543
    Event Type
    Death
    Date Received
    January 26, 2010
    Date of Event
    December 26, 2009
    Report Date
    January 26, 2010
    Manufacturer
    CARDINAL HEALTH PULMONETIC SYSTEMS
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VENTILATOR CIRCUIT WAS CHANGED ON A PULMONETIC LTV 1000 VENTILATOR AT 8:30 AM; RESPIRATORY THERAPIST DID NOT SET THE EXTERNAL PEEP VALUE FOR 10 CM H2O WHICH WAS ORDERED BY PHYSICIAN. ALTHOUGH THIS WAS A USER ERROR, I WOULD LIKE TO REPORT THE POTENTIAL FOR HARM WHEN VALUE IS NOT SET AND UNIT HAS NO ALARM SETTING FOR PEEP. PULMONETIC ALLOWS THE CLINICIAN TO SET EXTERNAL PEEP OF UP TO 20 CM H2O WITHOUT HAVING ANY ALARMS IF PEEP IS LOST. IT IS RARE THAT PTS REQUIRE 20 CM H2O, BUT IF THEY NEED IT AND ARE PLACED ON AN LTV 1000, IT COULD LEAD TO A POTENTIALLY DANGEROUS OUTCOME IF PEEP IS LOST AND NO ALARM OCCURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC LTV 1000 CBK CARDINAL HEALTH PULMONETIC SYSTEMS LTV 1000

    Patients

    Seq Age Sex Outcome Treatment
    1 16 MO Death