BEUDAMED
    FDA Adverse Event Death Summary report: N

    840 VENTILATOR

    MDR report key: 1840858 · Received September 15, 2010

    Report

    Report Number
    8020893-2010-00446
    Event Type
    Death
    Date Received
    September 15, 2010
    Date of Event
    July 29, 2010
    Report Date
    August 16, 2010
    Manufacturer
    PURITAN BENNETT CORP.
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE RISK MANAGER, THE VENTILATOR HAS NOT BEEN EVALUATED. IT IS NOT CLEAR IF A THIRD PARTY ORGANIZATION OR COVIDIEN WILL PERFORM EVALUATION TO THE DEVICE. (B)(4). THIS ISSUE IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT AN (B)(6) FEMALE EXPIRED ON AN 840 VENTILATOR. ON (B)(6)2010 AT 0800, NURSE ASSESSED THE PATIENT. NURSE REPORTED PATIENT HYPOXIC AND AGONAL BREATHING, DESPITE BEING ON VENTILATOR. NURSE REPORTED THE 840 VENTILATOR FAILED SPONTANEOUSLY AND IMMEDIATELY STARTED BAGGING PATIENT. NURSE OBSERVED GOOD CHEST RISE WITH BAG MASK VENTILATION. AT THIS TIME, THE RESPIRATORY THERAPIST BROUGHT IN DIFFERENT VENTILATOR. RESPIRATORY THERAPIST STATES INITIAL VENTILATOR WAS STILL PLUGGED INTO THE ELECTRICAL OUTLET WHEN ENTERING ROOM. PATIENT BECOMES BRADYCARDIC DURING BAG MASK VENTILATIONS. PATIENT'S HUSBAND IN ROOM DURING SITUATION AND STATED NO CPR. PATIENT WAS DNR AND HUSBAND STATED HE WANTED HER AT PEACE. ACCORDING TO THE RISK MANAGER, THE VENTILATOR SHUT DOWN AND DID NOT ALARM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death