BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 1040837 · Received May 9, 2008

    Report

    Report Number
    9611451-2008-00223
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    February 8, 2008
    Report Date
    April 9, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER & PAYKEL HEALTHCARE BY A HOSPITAL IN ANOTHER COUNTRY, THE PRODUCT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE TUBE END CONNECTORS WERE PULL TESTED. ONE OF THE CONNECTORS WAS HELD LOOSELY IN PLACE. THE OTHER CONNECTORS WERE NOT INSERTED FULLY INTO THE TUBE CUFFS BUT WERE FIRMLY IN PLACE. CONCLUSION: THE CONNECTORS ARE MACHINE INSERTED INTO THE END CUFFS OF THE BREATHING TUBE AND HELD TIGHTLY IN PLACE BY AN INTERFERENCE FIT. THE INCORRECT INSERTION LED TO A LOOSE FITTING OF THE CONNECTOR. OUR MONITORING AND TRENDING FOR THIS TYPE OF EVENT SHOWS RATE OF OCCURRENCE WORLDWIDE FOR THE LAST YEAR OF 0.0008 %.

    Description of Event or Problem · 1

    A HOSPITAL IN ANOTHER COUNTRY, REPORTED THROUGH OUR DISTRIBUTOR THAT THE CONNECTOR WAS EASY TO REMOVE FROM THE EXPIRATORY LIMB OF THE RT225 BREATHING CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT225

    Patients

    Seq Age Sex Outcome Treatment
    1