BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT UNHEATED BREATHING CIRCUIT

    MDR report key: 3441287 · Received October 31, 2013

    Report

    Report Number
    9611451-2013-00854
    Event Type
    Malfunction
    Date Received
    October 31, 2013
    Date of Event
    September 27, 2013
    Report Date
    October 4, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZO
    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 COMPLAINT RT134 ADULT UNHEATED BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INSPECTION. IT WAS VISUALLY INSPECTED, PRESSURE TESTED, AND IMMERSED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: THE PRESSURE TEST RESULT WAS OUT OF SPECIFICATION DUE TO EXCESSIVE LEAK. WHEN THE SUBJECT BREATHING CIRCUIT WAS IMMERSED IN THE WATER BATH, THE LEAK WAS OBSERVED AT THE CONNECTION BETWEEN THE LID AND THE BOWL OF THE EXPIRATORY WATER TRAP. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110905. 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 THE SUBJECT RT134 ADULT BREATHING CIRCUIT 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 RT134 ADULT UNHEATED 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 TO A DISTRIBUTOR THAT AN RT134 ADULT UNHEATED BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559381 ADULT UNHEATED BREATHING CIRCUIT BZO BZO FISHER & PAYKEL HEALTHCARE LIMITED RT134 110905

    Patients

    Seq Age Sex Outcome Treatment
    1