BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV 950

    MDR report key: 3112271 · Received April 17, 2006

    Report

    Report Number
    3112271
    Event Type
    Injury
    Date Received
    April 17, 2006
    Date of Event
    April 14, 2006
    Report Date
    April 14, 2006
    Manufacturer
    PULMONETICS
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT'S MONITOR AN LTV 950 VENTILATOR ALARMING, REGISTERED NURSE RESPONDED IMMEDIATELY TO BEDSIDE. HR 26, SATURATION NOT PICKING UP. PATIENT REMOVED FROM VENTILATOR AND HAND VENTILATED. VENTILATOR TUBING FOUND FILLED WITH WATER. PATIENT CYANOTIC AND LIMP. CHEST COMPRESSIONS INITIATED FOR 1 TO 1 1/2 MINUTES AND HEART RATE INCREASED TO 108. LTV TAKEN OUT OF SERVICE. UPON FURTHER INSPECTION OF THE LTV 950 RESPIRATOR WATER FEED CLAMP WAS FOUND TO BE OPEN ALLOWING WATER FROM BAG TO FLOW INTO CIRCUIT. THIS IS NORMALLY IN CLOSED POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LTV 950 RESPIRATOR CBK PULMONETICS

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO Life Threatening| R