BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUDSON COMFORT FLO SYSTEM

    MDR report key: 1518984 · Received October 30, 2009

    Report

    Report Number
    3004365956-2009-00062
    Event Type
    Other
    Date Received
    October 30, 2009
    Date of Event
    October 16, 2009
    Report Date
    October 20, 2009
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE IS NOT AVAILABLE FOR EVALUATION. THE INSTRUCTION FOR USE STATES IN THE WARNINGS THAT: "USE ONLY WITH COMPATIBLE HUDSON RCI HEATERS" AND "USE ONLY THE SUPPLIED CONCHA-COLUMN, OTHER CONCHA-COLUMN CONFIGURATIONS ARE NOT COMPATIBLE". IF ADDITIONAL INFORMATION IS RECEIVED FOR THIS COMPLAINT, A FOLLOW UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: A PREMATURE INFANT WAS PLACED ON HEATED HUMIDIFICATION VENTILATION INCORPORATING A TELEFLEX MEDICAL COMFORT FLO SYSTEM. THE COLUMN THAT COMES WITH THE COMFORT FLO SYSTEM WAS CHANGED OUT WITH A HUDSON LOW COMPLIANCE COLUMN RESULTING IN A GUSH OF WATER INTO THE BABY'S NOSE. THE BABY STOPPED BREATHING AND THE OXYGEN SATURATION DECREASED, WHICH REQUIRED CAPA WHILE THE INCORRECT COLUMN WAS CHANGED OUT AND A NEW COMFORT FLO SYSTEM WAS PUT INTO PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON COMFORT FLO SYSTEM COMFORT FLO HUMIDIFICATION SYSTEM BTT TELEFLEX MEDICAL 02D09/00604

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention