BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 2180541 · Received July 27, 2011

    Report

    Report Number
    9611451-2011-00448
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 27, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT206 IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. METHOD: THE RETURNED COMPLAINT BREATHING CIRCUIT WAS VISUALLY INSPECTED, PRESSURE TESTED AND SUBMERGED IN A WATER BATH TO TEST FOR LEAKS. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR THIS PRODUCT FOR THE LOT NUMBER PROVIDED. RESULTS: THE PRESSURE TEST REVEALED THE PRESSURE DROP TO BE OUTSIDE OF SPECIFICATION FOR THIS PRODUCT. THE WATER BATH TEST IDENTIFIED THE LEAK TO BE AT THE CONNECTION BETWEEN THE LID AND BOWL OF THE WATER TRAP. 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 RECONNECTED. THE USER INSTRUCTIONS FOR RT206 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 ALARM." (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 RT206 ADULT BREATHING CIRCUIT BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT206 110317

    Patients

    Seq Age Sex Outcome Treatment
    1