BEUDAMED
    FDA Adverse Event Death Summary report: N

    PNEUPAC VR1 EMERGENCY VENTILATOR/RESUSCITATOR

    MDR report key: 4274170 · Received November 17, 2014

    Report

    Report Number
    2183502-2014-00871
    Event Type
    Death
    Date Received
    November 17, 2014
    Report Date
    November 14, 2014
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    BTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE WAS RETURNED TO OUR SERVICE CENTER IN (B)(4). FUNCTIONAL TESTING PERFORMED BY THE TECHNICAL SERVICE PERSONNEL FOUND THE DEVICE TO OPERATE AS SPECIFIED. NO DEVICES ISSUES WERE FOUND. THE DEVICE WAS RETURNED TO THE CUSTOMER AND IS PRESUMED TO HAVE BEEN PLACED BACK INTO SERVICE. THIS INFORMATION WAS ENTERED INTO THE MANUFACTURER'S COMPLAINT DATABASE FOR TRACKING AND REPORTING PURPOSES.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING THAT THE LISTED DEVICE WAS IN USE ON A PATIENT WHEN THE DEVICE STOPPED FUNCTIONING. THE PATIENT WAS THEN MANUALLY VENTILATED USING AN AMBU BAG. THE REPORT STATES THAT TWO DAYS LATER, THE PATIENT EXPIRED DUE TO CARDIOPULMONARY ARREST. THE USER FACILITY IS UNSURE OF ANY RELATION BETWEEN CESSATION OF VENTILATOR AND THE PATIENT'S EXPIRATION TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741063 PNEUPAC VR1 EMERGENCY VENTILATOR/RESUSCITATOR BTL - VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) BTL SMITHS MEDICAL INTERNATIONAL LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death