BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 6042689 · Received October 19, 2016

    Report

    Report Number
    9611451-2016-00682
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 29, 2016
    Report Date
    October 4, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    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) PMA/510(K) THE RT267 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K103767. METHOD: THE COMPLAINT RT267 INFANT BREATHING CIRCUIT WAS RETURNED TO FPH IN (B)(4) FOR INSPECTION. IT WAS VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS. RESULTS: VISUAL INSPECTION REVEALED THAT THE RT267 INFANT BREATHING CIRCUIT HAD A CRACK ON ONE OF THE SWIVEL WYE PORTS. THE PRESSURE TEST RESULT WAS OUTSIDE OF THE SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 151107. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE DAMAGE NOTED ON THE RETURNED RT267 INFANT BREATHING CIRCUIT. ALL RT267 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITS, INCLUDING THE SWIVEL WYES, ARE VISUALLY INSPECTED, AND PRESSURE AND FLOW TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT INFANT BREATHING CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. MOREOVER, THE HOSPITAL REPORTED THAT THE DAMAGE OCCURRED AFTER A PERIOD OF USE, WHICH SUGGESTS THAT THE OBSERVED CRACKING OCCURRED AFTER THE SUBJECT RT267 INFANT BREATHING CIRCUIT WAS RELEASED FOR DISTRIBUTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT267 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITS 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 VENTILATOR ALARMS."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE SWIVEL WYE OF AN RT267 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND CRACKED AFTER FOUR DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690419 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT267 151107

    Patients

    Seq Age Sex Outcome Treatment
    1