BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 23306938 · Received October 15, 2025

    Report

    Report Number
    9611451-2025-01068
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Report Date
    December 3, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). THE 510(K) NUMBER FOR THE CHAMBER IS: K913368. METHOD: THE SUBJECT MR225 MANUAL FILL HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL (F&P) HEALTHCARE IN NEW ZEALAND WHERE IT WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF THE CHAMBER CONFIRMED THAT THERE WAS A CRACK ON THE CHAMBER DOME NEAR THE BASE. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE OBSERVED CRACK; HOWEVER, IT IS POSSIBLE THAT THE CHAMBER MIGHT BE IMPACT DAMAGED. EVERY MR225 CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. ANY CHAMBER WHICH FAILS THIS TEST IS REJECTED. THE USER INSTRUCTIONS THAT ACCOMPANY THE MR225 HUMIDIFICATION CHAMBER SPECIFY IN THE WARNING SECTION: DO NOT REUSE THIS PRODUCT. DO NOT USE BEYOND 7 DAYS MAXIMUM DURATION OF USE. DO NOT SOAK, WASH OR STERILIZE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS OR HAND SANTIZERS. CHECK ALL CONNECTIONS ARE TIGHT.

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: 510K PREMARKET SUBMISSION NUMBER IS NOT AVAILABLE. THE SUBJECT HUMIDIFICATION CHAMBER HAS BEEN REQUESTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN TAIWAN REPORTED THAT THE CHAMBER DOME OF MR225 CHAMBER PROVIDED AS PART OF THE AA400 OPTIFLOW ANAESTHESIA KIT WAS CRACKED BEFORE USE ON A PATIENT. THERE WAS NO PATIENT INVOVLEMENT.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN TAIWAN REPORTED THAT THE CHAMBER DOME OF MR225 CHAMBER PROVIDED AS PART OF THE AA400 OPTIFLOW ANAESTHESIA KIT WAS CRACKED BEFORE USE ON A PATIENT. THERE WAS NO PATIENT INVOVLEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2375876 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT KIT BTT FISHER & PAYKEL HEALTHCARE LTD AA400 2103370644

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown