BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 1030338 · Received April 15, 2008

    Report

    Report Number
    9611451-2008-00169
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    February 6, 2008
    Report Date
    March 3, 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

    METHOD: A MECHANICAL TEST WAS DONE ON THE RETURNED DEVICE BY ATTEMPTING TO MANUALLY REMOVE THE WATER TRAP BOWL. RESULTS: THE WATER BOWL COULD NOT BE REMOVED BY HAND, AS SHOULD NORMALLY HAPPEN WHEN THE OPERATOR NEEDS TO DRAIN THE CONDENSATE FROM THE WATER TRAP. CONCLUSION: THE WATER TRAP BOWL IS HELD IN PLACE BY A TAPERED FIT. SHOULD THE BOWL BE PUSHED INTO THE TAPERED CONNECTION TOO HARD IT WILL BECOME DIFFICULT TO REMOVE. THIS IS COMMON TO ALL TAPERED CONNECTIONS. IT HAD BEEN EITHER ASSEMBLED DURING PRODUCTION OR REASSEMBLED DURING USE TOO TIGHTLY. THIS COMPLAINT IS AN UNUSUAL EVENT. OUR MONITORING AND TRENDING FOR THIS TYPE OF EVENT SHOWS A RATE OF OCCURRENCE OF 0.0006%.

    Description of Event or Problem · 1

    A HOSPITAL IN JAPAN REPORTED TO OUR DISTRIBUTOR THAT DURING USE, THE HOSPITAL STAFF TRIED TO OPEN THE WATER TRAP OF AN RT125 INFANT BIAS FLOW BREATHING CIRCUIT TO DISPOSE OF THE WATER INSIDE. THEY REPORTED THEY WERE UNABLE TO OPEN THE WATER TRAP. 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 050113

    Patients

    Seq Age Sex Outcome Treatment
    1 HUMIDIFIER