BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BREATHING CIRCUIT

    MDR report key: 1052754 · Received May 23, 2008

    Report

    Report Number
    9611451-2008-00326
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 25, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICES WERE VISUALLY INSPECTED. RESULT: THE NASAL CANNULA USED WAS LONGER THAN EXPECTED FOR OXYGEN THERAPY WITH HUMIDIFIED GAS. THE CANNULA TUBING RECOMMENDED IN THE RT329 INSTRUCTIONS FOR USE ARE APPROX 45CM LONG. THE CANNULA TUBING IN THIS EVENT WAS APPROX TWICE THIS LONG. CONCLUSION: THE LONGER UNHEATED SECTION IN THIS LONGER CANNULA ALLOWED MORE COOLING. COOLING CAUSED THE HUMIDITY TO RAIN OUT AS WATER. THIS WATER THEN FLOWED OUT OF THE NASAL PRONGS OF THE CANNULA. HUMIDITY IS USED TO PREVENT DRYING OF THE NASAL PASSAGE WITH HIGH FLOW VENTILATION. THE CANNULA USED IN THIS EVENT WAS NOT IN THE LIST OF RECOMMENDED CANNULA IN THE RT329 INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    A HOSPITAL IN ANOTHER COUNTRY, REPORTED TO US THAT WATER WAS OBSERVED TO BE SHOOTING OUT OF THE CANNULA AND INTO THE PT'S NOSE WHILE USING A RT329 INFANT BREATHING CIRCUIT. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT329

    Patients

    Seq Age Sex Outcome Treatment
    1