BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 5902750 · Received August 24, 2016

    Report

    Report Number
    9611451-2016-00480
    Event Type
    Malfunction
    Date Received
    August 24, 2016
    Date of Event
    July 6, 2016
    Report Date
    July 28, 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 RT266 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS RETURNED TO FPH IN (B)(4) FOR INSPECTION. IT WAS VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: VISUAL INSPECTION REVEALED A CRACK ALONG ONE OF THE SWIVEL WYE PORTS. THE PRESSURE TEST RESULT WAS ALSO OUTSIDE OF SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 150915. CONCLUSION: WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE FAULT REPORTED BY THE HOSPITAL. ALL INFANT EVAQUA BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED BEFORE LEAVING THE PRODUCTION LINE, AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT INFANT BREATHING CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT266 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT ILLUSTRATE IN PICTORIAL FORMAT THE CORRECT SET-UP AND USE OF THE BREATHING CIRCUIT KIT. IT ALSO STATES 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 DISTRIBUTOR THAT THE SWIVEL WYE OF AN RT266 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND CRACKED WHEN THE BOX WAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554577 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT266 150915

    Patients

    Seq Age Sex Outcome Treatment
    1