BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 5874858 · Received August 14, 2016

    Report

    Report Number
    9611451-2016-00429
    Event Type
    Malfunction
    Date Received
    August 14, 2016
    Date of Event
    July 12, 2016
    Report Date
    July 19, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K103767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS RETURNED TO FPH IN (B)(4) FOR INSPECTION. IT WAS VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: THE SWIVEL WAS RETURNED DISASSEMBLED FROM THE ELBOW. NO DAMAGE WAS OBSERVED TO THE SWIVEL, ELBOW AND OTHER PARTS OF THE RETURNED BREATHING CIRCUIT. THE SWIVEL AND THE ELBOW WERE REASSEMBLED, AND THE WHOLE BREATHING CIRCUIT WAS PRESSURE TESTED. THE PRESSURE TEST RESULT WAS WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 160202. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE PROBLEM REPORTED BY THE HOSPITAL. THE INFANT SWIVEL AND ELBOW ARE ASSEMBLED USING A MACHINE TO ENSURE A CONSISTENT TIGHTNESS OF CONNECTION. THE SWIVEL IS THEN 100% PRESSURE AND FLOW TESTED AS PART OF THE INFANT BREATHING CIRCUIT BEFORE LEAVING THE PRODUCTION LINE. ANY BREATHING CIRCUITS THAT FAIL THESE TESTS ARE REJECTED. THE SUBJECT RT265 INFANT BREATHING CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT ALSO 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 AND THE ELBOW OF AN RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT HAD LOOSE CONNECTION. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526849 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT265 160202

    Patients

    Seq Age Sex Outcome Treatment
    1