BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 15686600 · Received October 27, 2022

    Report

    Report Number
    9611451-2022-01004
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Date of Event
    October 16, 2022
    Report Date
    October 18, 2022
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    UDI-DI
    09420012430205
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTED DATA: SECTION B5 DESCRIBE EVENT OR PROBLEM: A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN, VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT A RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST DURING THE PRE-USE INSPECTION. SECTION D1 BRAND NAME:INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT. SECTION D2 COMMON DEVICE NAME: BZE. SECTION D4 MODEL #, CATALOG #: RT265. METHOD: THE COMPLAINT RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS RETURNED TO FPH IN NEW ZEALAND FOR INVESTIGATION, WHERE IT WAS VISUALLY INSPECTED AND LEAK TESTED. RESULTS: VISUAL INSPECTION REVEALED NO VISIBLE DAMAGE WAS FOUND TO ANY PART OF THE RETURNED BREATHING CIRCUIT. THE LEAK TEST REVEALED THAT THE BREATHING CIRCUIT WAS OUTSIDE OF SPECIFICATION AND WAS LEAKING FROM THE SWIVEL DUCKBILL. FURTHER INSPECTION SHOWED THAT DAMAGE TO THE DUCKBILL SLIT WAS FOUND. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE REPORTED FAILURE MODE AT THIS STAGE. ALL RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS 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 SPECIFICATIONS AT THE TIME OF PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT265 INFANT DUAL-HEATED EVAQUA2 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." "ENSURE APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS ARE SET BEFORE CONNECTING BREATHING SET TO PATIENT."

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN, VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER FAILED THE VENTILATOR LEAK TEST DURING THE PRE-USE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN, VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT A RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST DURING THE PRE-USE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2668262 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT265 2101831888 09420012430205
    2724796 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT265 2101831888 09420012430205

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown F&P RT265 INFANT EVAQUA2 BREATHING CIRCUIT.