BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 24354956 · Received February 16, 2026

    Report

    Report Number
    9611451-2026-00552
    Event Type
    Malfunction
    Date Received
    February 16, 2026
    Date of Event
    December 29, 2025
    Report Date
    May 18, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    UDI-DI
    09420012431158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). SECTION G4: THE RT268 INFANT EVAQUA2 BREATHING CIRCUIT IS NOT SOLD IN THE USA, BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K103767. SECTION H11: THE SUBJECT RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT IS CURRENTLY EN ROUTE TO FISHER & PAYKEL (F&P) HEALTHCARE IN NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(6). SECTION G4: THE RT268 INFANT EVAQUA2 BREATHING CIRCUIT IS NOT SOLD IN THE USA, BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K103767. SECTION H11: METHOD: THE INSPIRATORY AND EXPIRATORY LIMBS OF THE SUBJECT RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WERE RECEIVED AT FISHER & PAYKEL HEALTHCARE (F&P) IN NEW ZEALAND FOR EVALUATION, WHERE THEY WERE VISUALLY INSPECTED AND LEAK TESTED. RESULTS: VISUAL INSPECTION IDENTIFIED NO DAMAGE OR DEFECTS WITH THE RETURNED BREATHING CIRCUIT LIMBS. LEAK TESTING CONFIRMED THAT THE RETURNED COMPONENTS WERE WITHIN SPECIFICATION. CONCLUSION: BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER AND WITHOUT THE RETURN OF THE COMPLETE SUBJECT DEVICE, WE ARE UNABLE TO CONFIRM OR DETERMINE THE EXACT CAUSE OF THE REPORTED FAULT. ALL RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITS ARE VISUALLY INSPECTED, AS WELL AS PRESSURE AND FLOW TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT BREATHING CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT SHOW IN PICTORIAL FORMAT THE CORRECT SET-UP OF THE CIRCUIT AND ALSO STATE THE FOLLOWING: - VISUALLY INSPECT BREATHING SETS FOR DAMAGE (E.G. A CRUSHED TUBE OR CRACKED CONNECTOR) BEFORE USE AND REPLACE IF DAMAGED. - PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT. - CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE. - ENSURE APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS ARE SET BEFORE CONNECTING BREATHING SET TO PATIENT. - APPROPRIATE PATIENT MONITORING (E.G. OXYGEN SATURATION) MUST BE USED AT ALL TIME.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN IRELAND REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT AN RT268 INFANT EVAQUA2 BREATHING CIRCUIT TRIGGERED A VENTILATOR LEAK ALARM ON AN SLE6000 VENTILATOR. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN IRELAND REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT AN RT268 INFANT EVAQUA2 BREATHING CIRCUIT TRIGGERED A VENTILATOR LEAK ALARM ON AN SLE6000 VENTILATOR. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242091 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE LTD RT268 2102393904 09420012431158

    Patients

    Seq Age Sex Outcome Treatment
    1