BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 3325818 · Received September 4, 2013

    Report

    Report Number
    9611451-2013-00665
    Event Type
    Malfunction
    Date Received
    September 4, 2013
    Report Date
    August 8, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT205 ADULT INSPIRATORY HEATED BREATHING CIRCUIT 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. THE COMPLAINT DEVICES ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE PROVIDED ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT205 ADULT INSPIRATORY HEATED BREATHING CIRCUIT 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: FIVE UNSEALED RT205 ADULT BREATHING CIRCUIT KITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INSPECTION. THE RETURNED BREATHING CIRCUITS WERE VISUALLY INSPECTED, PRESSURE TESTED, AND IMMERSED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: THE PRESSURE TEST RESULTS WERE OUT OF SPECIFICATION DUE TO EXCESSIVE LEAK. WHEN THE SUBJECT BREATHING CIRCUITS WERE IMMERSED IN THE WATER BATH, THE LEAK WAS OBSERVED AT THE CONNECTION BETWEEN THE LID AND THE BOWL OF THE WATER TRAP. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 130419 . CONCLUSION: THE BREATHING CIRCUIT WATER TRAP CONSISTS OF A BOWL AND A LID, WHICH CAN BE SEPARATED TO ALLOW THE CAREGIVER TO EMPTY THE WATER TRAP. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS ANY LEAK MUST HAVE DEVELOPED AFTER IT WAS RELEASED FOR DISTRIBUTION, DURING TRANSPORT, STORAGE OR USE, POSSIBLY BY DISTORTION OF THE WATER TRAP WHEN THE BOWL WAS CONNECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT205 ADULT INSPIRATORY HEATED BREATHING CIRCUIT STATE THE FOLLOWING: "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE ALARMS."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THREE RT205 ADULT INSPIRATORY HEATED BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Description of Event or Problem · 1

    A HOSPITAL IN THE UK REPORTED THAT THREE RT205 ADULT INSPIRATORY HEATED BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438694 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT205 130419

    Patients

    Seq Age Sex Outcome Treatment
    1