BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 23010895 · Received September 9, 2025

    Report

    Report Number
    9611451-2025-00866
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 15, 2025
    Report Date
    November 7, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    UDI-DI
    09420012431158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: THE RT268 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. FISHER & PAYKEL (F&P) HEALTHCARE IS CURRENTLY IN THE PROCESS OF FINALIZING THE INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: THE RT268 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 CHAMBERS WERE REQUESTED TO BE PROVIDED TO FISHER & PAYKEL (F&P) HEALTHCARE IN NEW ZEALAND FOR EVALUATION. RESULTS: REVIEW OF THE PROVIDED VIDEO CONFIRMED THE REPORTED CRACKS ON THE DOMES OF ALL SEVEN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS. CONCLUSION: THE PRESENCE OF THE REPORTED CRACKS WAS CONFIRMED BY REVIEWING THE VIDEO PROVIDED. THE CAUSE OF THE OBSERVED CRACKS WAS NOT DETERMINED. THE USER INSTRUCTIONS PROVIDED WITH THE RT268 BREATHING CIRCUIT INCLUDE THE FOLLOWING: - "DO NOT USE THE CHAMBER IF THE SEALS ARE NOT INTACT OF IF IT HAS BEEN DROPPED." - "VISUALLY INSPECT BREATHING SETS FOR DAMAGE (E.G. A CRUSHED TUB OR CRACKED CONNECTOR) BEFORE USE AND REPLACE IF DAMAGED." - "DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS." - "ENSURE APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS ARE SET BEFORE CONNECTING BREATHING SET TO PATIENT." - "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT."

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT SEVEN MR290V AUTOFEED HUMIDIFICATION CHAMBERS, PROVIDED AS A PART OF RT268 INFANT EVAQUA2 BREATHING CIRCUITS , WERE FOUND CRACKED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT SEVEN MR290V AUTOFEED HUMIDIFICATION CHAMBERS, PROVIDED AS A PART OF RT268 INFANT EVAQUA2 BREATHING CIRCUITS, WERE FOUND CRACKED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2825690 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE LTD RT268 2103470926 09420012431158

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown