BEUDAMED
    FDA Adverse Event Death Summary report: N

    840 VENTILATOR

    MDR report key: 3934127 · Received June 27, 2014

    Report

    Report Number
    8020893-2014-01517
    Event Type
    Death
    Date Received
    June 27, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AT HOSPITAL SITE. THE VENTILATOR WARM UP WAS COMPLETED AND NO ERRORS WERE RECORDED IN THE DEVICE MEMORY. THE UNIT PASSED ALL CALIBRATIONS, THE EXTENDED SELF TEST (EST), THE SHORT SELF TEST (SST), O2 CALIBRATION, ELECTRICAL SAFETY AND THE PERFORMANCE VERIFICATION TEST (PVT). THE DEVICE WAS THEN PLACED BACK IN SERVICE. (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO THAT ALLEGED THAT A PT EXPIRED WHILE ON AN 840 VENTILATOR. THE CUSTOMER REPORTED THAT AN ICU PT WITH KNOW CHRONIC DISEASE WAS INTUBATED FOR A 24 HOUR PERIOD AND THEN SUDDENLY WENT INTO CARDIAC ARREST. THE CUSTOMER REPORTED THAT THE VENTILATOR WAS ALARMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378253 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Death