BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAREFUSION

    MDR report key: 4810393 · Received June 1, 2015

    Report

    Report Number
    2021710-2015-01070
    Event Type
    Death
    Date Received
    June 1, 2015
    Date of Event
    March 26, 2015
    Report Date
    April 30, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    CAREFUSION HAS REQUESTED ADDITIONAL INFORMATION FROM THE USER FACILITY ON THE REPORTED EVENT VIA EMAIL. AS OF (B)(6) 2015 THERE HAS BEEN NO ADDITIONAL INFORMATION PROVIDED BY THE USER FACILITY. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION IN RELATION TO THE PT'S DEATH, THEREFORE NO EVALUATION OF THE DEVICE WAS PERFORMED.

    Description of Event or Problem · 1

    THE USER FACILITY'S RESPIRATORY THERAPY DIRECTOR REPORTED THAT THE PT PASSED AWAY WHILE CONNECTED TO THIS DEVICE AND THAT NO ALARM CONDITIONS OCCURRED. THERE ARE NO ALLEGATIONS OF A DEVICE MALFUNCTION ASSOCIATED WITH THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352014 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE/CBK CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ASKU Death ASKU