BEUDAMED
    FDA Adverse Event Death Summary report: N

    PURITAN BENNETT VENTILATOR

    MDR report key: 1678882 · Received May 5, 2010

    Report

    Report Number
    1678882
    Event Type
    Death
    Date Received
    May 5, 2010
    Date of Event
    May 10, 2009
    Report Date
    May 29, 2009
    Manufacturer
    COVIDIEN PURITAN BENNETT
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED FROM OUT LYING FACILITY BEING MANUALLY VENTILATED WITH AMBU BAG - PLACED ON 840 VENT, ALARM SOUNDED, SET TAKEN OFF VENT AND MANUALLY BAGGED WITH 100% O2 VIA AMBU BAG. SYSTEM CHECK PERFORMED, AT THE SAME TIME PT CHECKED AND FOUND TO BE IN PEA; CPR INITIATED AND CODE BLUE CALLED, PT EXPIRED. PT WAS ON VENTILATOR APPROXIMATELY 20-30 SECS BEFORE TAKEN OFF AND MANUALLY VENTILATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PURITAN BENNETT VENTILATOR VENTILATOR CBK COVIDIEN PURITAN BENNETT 840

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death