BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 21521480 · Received March 4, 2025

    Report

    Report Number
    9611451-2025-00194
    Event Type
    Malfunction
    Date Received
    March 4, 2025
    Date of Event
    February 3, 2025
    Report Date
    June 30, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). SECTION D4: DEVICE IDENTIFICATION DETAILS WERE NOT RECEIVED. 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. THE SUBJECT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER HAS BEEN REQUESTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION D4: DEVICE IDENTIFICATION DETAILS WERE NOT RECEIVED. 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 SUBJECT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL (F&P) HEALTHCARE IN NEW ZEALAND WHERE IT WAS VISUALLY INSPECTED AND ANALYSED. RESULTS: VISUAL INSPECTION OF THE RETURNED CHAMBER REVEALED THAT THERE WAS NO VISIBLE DAMAGE TO THE CHAMBER. FURTHER ANALYSIS OF THE CHAMBER CONFIRMED THAT THERE WAS A LEAK AT THE DOME BASE CONNECTION. CONCLUSION: BASED ON OUR INVESTIGATION, THE LEAK IS LIKELY TO HAVE BEEN CAUSED DUE TO AN OUT OF SPECIFICATION CHAMBER BASE. EVERY MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS AND ANY HOLES, CRACKS, OR LEAKS WOULD BE IDENTIFIED DURING THIS PROCESS. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. ANY CHAMBER WHICH FAILS THESE TESTS IS REJECTED. THE SUBJECT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT267 BREATHING CIRCUITS STATE THE FOLLOWING: DO NOT USE THE CHAMBER IF THE SEALS ARE NOT INTACT WHEN RECEIVED, OR IF IT HAS BEEN DROPPED. ENSURE THERE IS A WATER SUPPLY CONNECTED TO THE CHAMBER AND THAT WATER IS PRESENT WITHIN THE CHAMBER. APPROPRIATE PATIENT MONITORING (E.G. OXYGEN SATURATION) MUST BE USED AT ALL TIMES. ENSURE APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS ARE SET BEFORE CONNECTING BREATHING SETS TO PATIENT. VISUALLY INSPECT BREATHING SETS FOR DAMAGE (E.G. CRUSHED TUBE OR CRACKED CONNECTOR) BEFORE USE AND REPLACE IF DAMAGED.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT AN MR290V AUTOFEED HUMIDIFICATION CHAMBER, PROVIDED AS A PART OF AN RT267 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT FOR SLE2000 VENTILATORS, WAS FOUND LEAKING WATER DURING PATIENT USE. THERE WAS NO PATIENT HARM REPORTED.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT AN MR290V AUTOFEED HUMIDIFICATION CHAMBER, PROVIDED AS A PART OF AN RT267 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT FOR SLE2000 VENTILATORS, WAS FOUND LEAKING WATER DURING PATIENT USE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2480248 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE LTD RT267

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown F&P HEALTHCARE MR850 RESPIRATORY HUMIDIFIER| F&P HEALTHCARE MR850 RESPIRATORY HUMIDIFIER| SLE2000 VENTILATOR| SLE2000 VENTILATOR