BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 4215910 · Received October 30, 2014

    Report

    Report Number
    9611451-2014-00837
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Report Date
    October 3, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K103767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ONLY ONE RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. IT WAS VISUALLY INSPECTED AND PRESSURE TESTED FOR A LEAK. RESULTS: VISUAL INSPECTION REVEALED NO DAMAGE TO THE SWIVEL ELBOW AND SWIVEL WYE PIECE. THE INSPIRATORY AND EXPIRATORY CONNECTIONS TO THE SWIVEL WYE WERE FOUND TO BE TIGHT. PRESSURE TEST REVEALED THAT THE RETURNED CIRCUIT WAS WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 140611. CONCLUSION: NO FAULT WAS FOUND WITH THE RETURNED RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT. WE WERE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE REPORTED PROBLEM. ALL RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE AND FLOW TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT265 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 HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT THE SWIVEL WYE DISCONNECTED ON TWO RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITS. ONE WAS FOUND DURING USE AND THE OTHER WAS AFTER PATIENT USE. O PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(4) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT THE SWIVEL WYE DISCONNECTED ON TWO RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITS. ONE WAS FOUND DURING USE AND THE OTHER WAS AFTER PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695982 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT265 140611

    Patients

    Seq Age Sex Outcome Treatment
    1