BEUDAMED
    FDA Adverse Event Death Summary report: N

    PURITAN BENNETT COMPANION 2800

    MDR report key: 125524 · Received October 7, 1997

    Report

    Report Number
    125524
    Event Type
    Death
    Date Received
    October 7, 1997
    Date of Event
    September 17, 1997
    Report Date
    October 7, 1997
    Manufacturer
    NELL COR-PURITAN BENNETT INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN FOUND EXPIRED, THE PT WAS ON A PURITAN BENNETT 2800 VENTILATOR. AN HME (HEAT MOISTURE EXCHANGER) WAS IN PLACE AS THE HUMIDIFICATION DEVICE. THE VENTILATOR WAS RUNNING, HOWEVER, THE PT'S CHEST WAS NOT RISING AND FALLING. THE HME WAS FOUND TO BE PARTIALLY FILLED WITH PULMONARY SECRETIONS, THE PRESSURE MANOMETER WAS RISING TO 40 CMH20 DURING EACH INSPIRATORY CYCLE OF THE VENTILATOR. THE PRESSURE LIMIT (THE PRESSURE AT WHICH THE PRESSURE RELIEF VALVE OPENS, DUMPING AND REMAINING TIDAL VOLUME INTO THE ATMOSPHERE) WAS FOUND TO BE SET AT 40 CMH20 AND THE HIGH PRESSURE ALARM WAS SET AT 54 CMH20. THE COMBINATION OF THE RESISTANCE IT WAS TAKING TO VENTILATE THE PT'S CHEST AND THE ADD'L RESISTANCE CREATED BY THE WET HME CAUSED THE PRESSURE TO INCREASE. DURING EACH INSPIRATORY CYCLE, THE PRESSURE WOULD REACH 40 CMH20, THE PRESSURE LIMIT WOULD BE REACHED, THE VALVE WOULD OPEN, A PORTION OF THE TIDAL VOLUME WAS BEING DUMPED DECREASING THE AMOUNT OF AIR GOING INTO THE PT WITH EACH BREATH. THE HIGH PRESSURE ALARM SHOULD HAVE BEEN SET TO MATCH THE PRESSURE LIMIT SO THAT THE ALARM WOULD HAVE SOUNDED IF A PRESSURE LIMIT SITUATION EXISTED. THE HIGH PRESSURE ALARM NEVER SOUNDED BECAUSE THE ALARM WAS SET HIGHER THAN THE PRESSURE LIMIT (THE POINT AT WHICH THE ALARM WAS SET TO BE TRIGGERED, WAS NEVER REACHED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PURITAN BENNETT COMPANION 2800 VENTILATOR CBK NELL COR-PURITAN BENNETT INC. 2800 N.A.*

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death HME-HEAT MOISTURE EXCHANGER.