BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEWPORT HT50 VENTILATOR

    MDR report key: 719845 · Received May 19, 2006

    Report

    Report Number
    2023050-2006-00027
    Event Type
    Death
    Date Received
    May 19, 2006
    Date of Event
    April 23, 2006
    Report Date
    April 24, 2006
    Manufacturer
    FLIGHT MEDICAL LTD.
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS ABLE TO BREATHE ON HIS OWN FOR APPROX 30 MINUTES AT A TIME. AFTER A FAMILY MEMBER CHANGED BREATHING CIRCUIT ON THE VENTILATOR, PT CLAIMED THAT HE WAS NOT GETTING ENOUGH BREATH FROM THE VENTILATOR. THE FAMILY MEMBER DECIDED TO SWITCH PT TO THE OTHER VENTILATOR. AGAIN PT CLAIMED THAT HE WAS NOT GETTING ENOUGH BREATH. AT THAT POINT, FAMILY DISCONNECTED PT FROM THE SECOND VENTILATOR AND STARTED USING A RESUSCITATION BAG TO VENTILATE HIM. THE PT THEN SEEMED FINE FOR AWHILE. HOWEVER, AFTER A FEW MINUTES, THEY NOTICED A LOT OF BLOOD FROM HIS TRACHEOSTOMY. PARAMEDICS WERE CALLED AND THE PT WAS TAKEN TO THE HOSPITAL. HE WAS STABILIZED, BUT DIED EARLY THE NEXT MORNING. IT IS STILL UNKNOWN WHETHER THE VENTILATOR WAS MALFUNCTIONING AND RESULTED IN THE ADVERSE EVENT. (PLEASE ALSO REFER TO MDR REPORT # 2023050-2006-00028 FOR THE SECOND VENTILATOR.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWPORT HT50 VENTILATOR VENTILATOR CBK FLIGHT MEDICAL LTD. HT50-H1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death