BEUDAMED
    FDA Adverse Event Death Summary report: N

    COVIDIEN PURRITIN BENNETT

    MDR report key: 3229888 · Received July 10, 2013

    Report

    Report Number
    MW5030867
    Event Type
    Death
    Date Received
    July 10, 2013
    Date of Event
    June 22, 2013
    Report Date
    July 10, 2013
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT'S HEART RATE STARTED TO DROP ON THE MONITOR INTO THE 40'S WHEN THE NURSE ENTERED THE ROOM, SHE NOTED THE PT WAS CYANOTIC AND VENTILATOR WAS CONNECTED TO THE PT BUT THE MACHINE WAS NOT WORKING, NO LIGHTS, NO SOUNDS, NO ALARMS. ONLY THE GREEN LED WAS BLINKING ON AND OFF. PT WAS SEEN BY RESPIRATORY AND NURSING 10 MINUTES PRIOR TO THE EVENT AND ALL WAS BASELINE FOR THIS PT. CODE WAS CALLED BUT UNSUCCESSFUL IN RESUSITATION. PER DOCUMENTATION, THERE WAS NO DELAY IN CARE. PT HAD CODED IN PAST, BUT WAS SUCCESSFULLY REVIVED. PT DID HAVE MULTIPLE CO-MORBIDITIES INCLUDING TYPE 1 DIABETES, OPEN WOUNDS, MORBIDLY OBESE, AND WAS BEING EVALUATED FOR POSSIBLE CARDIAC COMPLICATION ASSOCIATED WITH HIS POOR MEDICAL HISTORY. PRODUCT WAS ASSESSED BY COVIDIEN ENGINEERS ON SITE AND WAS UNABLE TO RETRIEVE DATA OR MAKE UNIT OPERATIONAL. PRODUCT WILL BE SENT TO MFR FOR ANALYSIS. DATES OF USE: (B)(6) 2013 -- (B)(6) 2013. REASON FOR USE: VENTILATOR DEPENDANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315276 COVIDIEN PURRITIN BENNETT 840 VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death