BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC FIRST RESPONDER WITHOUT ALARMS

    MDR report key: 1474118 · Received June 26, 2009

    Report

    Report Number
    2182466-2009-00010
    Event Type
    Malfunction
    Date Received
    June 26, 2009
    Date of Event
    May 23, 2009
    Report Date
    May 28, 2009
    Manufacturer
    SMITHS MEDICAL PM, INC.
    Product Code
    BTL
    PMA / PMN Number
    K960515
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITHS MEDICAL PM, INC. IMPORTS THE VENTILATOR FROM SMITHS MEDICAL INTERNATIONAL, LTD. (B) (4). SMITHS MEDICAL PM, INC. KITS A PT CIRCUIT AND REGULATOR AND PACKAGES IT WITH THE VENTILATOR, THEREFORE, SMITHS MEDICAL PM, INC. IS REPORTING AS THE MANUFACTURER. AFTER THE INCIDENT, THE VENTILATOR WAS EVALUATED BY THE USER FACILITY'S BIOMEDICAL ENGINEERING DEPT, WHERE IT PASSED FUNCTIONAL TESTING. THE VENTILATOR WAS RETURNED TO SMITHS MEDICAL PM, INC. FOR EVALUATION. THE VENTILATOR WAS FOUND TO BE READING LOW. THE RELIEF PRESSURE VALVE WAS LEAKING. THE VALVE WAS TAKEN APART AND WAS MISSING THE INTERNAL PLUNGER. ONCE A NEW RELIEF PRESSURE VALVE WAS USED, THE UNIT PASSED FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    THE PT WAS CONNECTED TO THE VENTILATOR IN PREPARATION OF TRANSFER TO ANOTHER FACILITY. AFTER MOVING THE PT TO EMS UNIT, THE EMT ATTEMPTED TO CONFIRM ENDOTRACHEAL TUBE PLACEMENT VIA AUSCULATION OF BREATH SOUNDS. BREATH SOUNDS AND CHEST RISE NOTED TO BE ABSENT AND NOTED INCREASING CYANOSIS. THE VENTILATOR WAS DISCONNECTED AND THE EMT BEGAN PROVIDING VENTILATIONS VIA BAG VALVE. PT HAD EXPERIENCED BRIEF PERIOD OF CARDIAC ARREST. THE PT REQUIRED CARDIAC RESUSCITATION INCLUDING IV MEDICATIONS AND CHEST COMPRESSIONS. PT CONDITION IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUPAC FIRST RESPONDER WITHOUT ALARMS EMERGENCY VENTILATOR BTL SMITHS MEDICAL PM, INC. 2R

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention