BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 2343006 · Received November 20, 2011

    Report

    Report Number
    9611451-2011-00720
    Event Type
    Malfunction
    Date Received
    November 20, 2011
    Date of Event
    October 14, 2011
    Report Date
    October 25, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K033710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED COMPLAINT BREATHING CIRCUIT WAS PRESSURE TESTED AND SUBMERGED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: A LEAK WAS FOUND IN THE INSPIRATORY AND EXPIRATORY WATER TRAP. THE WATER TRAP OF THE BREATHING CIRCUIT CONSISTS OF TWO PARTS WHERE THE LOWER PART CAN BE REMOVED DURING USE FOR DRAINING WATER. THE WATER TRAP LEAK WAS LOCATED AT THE SEAL BETWEEN THE WATER TRAP BOWL AND THE WATER TRAP LID. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT NUMBER 110907. CONCLUSION: ALL CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS ANY LEAK MUST HAVE DEVELOPED POST PRODUCTION DURING TRANSPORT, STORAGE OR USE, POSSIBLY BY DISTORTION OF THE WATER TRAP WHEN THE BOWL WAS CONNECTED. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT134 ADULT BREATHING CIRCUIT STATE THE FOLLOWING: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE VENTILATOR ALARMS." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT AIR LEAKED FROM THE WATER TRAP OF AN RT134 ADULT BREATHING CIRCUIT. THIS WAS FOUND BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT134 110907

    Patients

    Seq Age Sex Outcome Treatment
    1