BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 22102880 · Received May 29, 2025

    Report

    Report Number
    9611451-2025-00480
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    May 1, 2025
    Report Date
    September 19, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    UDI-DI
    09420012431158
    PMA / PMN Number
    SEE H11
    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 + H4: THE LOT NUMBER, EXPIRY DATE, AND DATE OF MANUFACTURE OF THE REPORTED RT268 INFANT EVAQUA2 BREATHING CIRCUITS ARE: - 2102806974, 28-SEP-2028, 28-SEP-2023. - 2101187165, 06-JUL-2025, 06-JUL-2020. - 2102247948, 04-JUL-2027, 04-JUL-2022. - 2100987129, 20-JAN-2025, 20-JAN-2020. 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 EVAQUA2 BREATHING CIRCUITS HAVE BEEN REQUESTED TO BE RETURNED 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 D4 + H4: THE LOT NUMBER, EXPIRATION DATE, AND DEVICE MANUFACTURE DATE OF THE REPORTED RT268 INFANT EVAQUA2 BREATHING CIRCUITS ARE: 2102806974, 28-SEP-2028, 28-SEP-2023. 2101187165, 06-JUL-2025, 06-JUL-2020. 2102247948, 04-JUL-2027, 04-JUL-2022. 2100987129, 20-JAN-2025, 20-JAN-2020. 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 SUBJECT RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS, 900MR869 TEMPERATURE/FLOW PROBES, AND ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT WERE REQUESTED TO BE PROVIDED TO FISHER & PAYKEL (F&P) HEALTHCARE NEW ZEALAND FOR EVALUATION. IN ADDITION, A REVIEW OF THE MANUFACTURING RECORDS FOR THE REPORTED DEVICES WAS COMPLETED. RESULTS: THE HEALTHCARE FACILITY REPORTED THAT THE 900MR869 TEMPERATURE/FLOW PROBES AND THEIR IDENTIFYING INFORMATION WERE NOT AVAILABLE FOR RETURN. THE SUBJECT RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS WERE RECEIVED AT FISHER & PAYKEL HEALTHCARE (F&P) IN NEW ZEALAND FOR EVALUATION, WHERE THEY WERE VISUALLY INSPECTED. VISUAL INSPECTION OF THE RETURNED DEVICES IDENTIFIED NO VISIBLE DAMAGE OR DEFECTS. A REVIEW OF THE MANUFACTURING RECORDS OF THE LOT BATCHES OF THE RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS WAS ALSO PERFORMED. THE DEVICES IN THE MANUFACTURING LOTS PASSED ALL THE REQUIRED QUALITY CONTROL MEASURES, CONFIRMING THEY WERE MANUFACTURED IN ACCORDANCE WITH SPECIFICATIONS. ADDITIONALLY, NO NON-CONFORMANCES WERE NOTED DURING THE MANUFACTURING PROCESS OF THE SUBJECT LOTS. CONCLUSION: BASED ON THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY, OUR INVESTIGATION, AND REVIEW OF THE MANUFACTURING RECORDS, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED ISSUE. AS PART OF DESIGN VALIDATION AND VERIFICATION ACTIVITIES, ALL F&P HEALTHCARE PRODUCTS ARE TESTED TO ENSURE THEY MEET DOCUMENTED PRODUCT REQUIREMENTS AND SPECIFICATIONS. AT THE END OF THE FINAL ASSEMBLY PROCESS, ALL RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS ARE 100% TESTED AS FOLLOWS: FUNCTIONAL TESTING FOR LEAK. VISUAL INSPECTIONS FOR ANY VISIBLE DEFECTS AND CONTAMINATION. RESISTANCE TESTING OF THE HEATER WIRE. AT THE END OF THE FINAL ASSEMBLY PROCESS, ALL 900MR869 TEMPERATURE/FLOW PROBE ARE 100% TESTED AS FOLLOWS: FUNCTIONAL TESTING OF TEMPERATURE/FLOW PROBE. VISUAL INSPECTIONS FOR ANY VISIBLE DEFECTS AND CONTAMINATION. RESISTANCE TESTING. THE INSTRUCTIONS FOR USE ACCOMPANYING THE RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS SHOW IN PICTORIAL FORMAT THE CORRECT SET-UP OF THE CIRCUIT AND ALSO STATE THE FOLLOWING: 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. CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE. APPROPRIATE PATIENT MONITORING (E.G. OXYGEN SATURATION) MUST BE USED AT ALL TIMES. FAILURE TO MONITOR THE PATIENT (E.G. IN THE EVENT OF AN INTERRUPTION TO GAS FLOW) MAY RESULT IN SERIOUS HARM, OR DEATH. THE INSTRUCTIONS FOR USE FOR THE 900MR869 TEMPERATURE/FLOW PROBES OUTLINES THE CORRECT SET-UP OF THE TEMPERATURE PROBE AND ALSO STATE THE FOLLOWING: ENSURE THAT BOTH TEMPERATURE PROBE SENSORS ARE CORRECTLY AND SECURELY FITTED. PUSH THE AIRWAY PROBE AND CHAMBER PROBE INTO BREATHING CIRCUIT MAKING SURE THEY ARE CORRECTLY LOCATED AND PUSHED INTO PLACE. PERFORM VENTILATOR LEAK TEST ON THE BREATHING CIRCUIT BEFORE USE. THERE IS A RESIDUAL RISK ASSOCIATED WITH USE OF THIS PRODUCT, EVEN IF USED AS INTENDED. FOLLOWING ALL INSTRUCTIONS AND WARNINGS PROVIDED, THE RISK OF HYPOXIC INJURY, SKIN BURNS, AIRWAY BURNS, AIRWAY INJURY, LUNG INJURY, ELECTRIC SHOCK INJURY, MUSCULOSKELETAL INJURY, AND HYPOTHERMIA REMAINS. THESE RISKS MAY RESULT IN SERIOUS INJURY OR DEATH. THE INSTRUCTIONS FOR USE ACCOMPANYING EACH MR850 RESPIRATORY HUMIDIFIER OUTLINES THE CORRECT SET-UP OF THE DEVICE IN ACCORDANCE WITH INSTRUCTIONS AND WARNINGS, AND ALSO STATES THE FOLLOWING: ENSURE THAT BOTH TEMPERATURE PROBE SENSORS ARE CORRECTLY AND SECURELY FITTED. VISUALLY INSPECT THE HUMIDIFIER AND ACCESSORIES FOR DAMAGE BEFORE USE AND REPLACE IF DAMAGED. THIS PRODUCT IS FOR USE UNDER THE SUPERVISION OF TRAINED MEDICAL PERSONNEL. ENSURE THAT APPROPRIATE VENTILATOR AND/OR PATIENT MONITOR ALARMS ARE SET, CONNECTIONS ARE SECURE AND A LEAK TEST IS COMPLETED BEFORE USE. THE MR850 TECHNICAL MANUAL ALSO OUTLINES THE ACTION REQUIRED WHEN A FLASHING 'AIRWAY PROBE' INDICATOR IS ACCOMPANIED BY AN AUDIBLE ALARM, INCLUDING TO 'CHECK FOR PROPER INSERTION OF THE AIRWAY PROBE INTO A CORRECTLY CONFIGURED BREATHING CIRCUIT', AND TO 'ADJUST AS NECESSARY'. THE TECHNICAL MANUALS ALSO OUTLINE THE 6 MONTHLY AND ANNUAL MAINTENANCE TASKS TO ENSURE THE HUMIDIFIER, AND ITS ACCESSORIES ARE IN WORKING ORDER. IN ADDITION, IT ALSO STATES THAT THE ACCESSORIES USED WITH THE MR850 RESPIRATORY HUMIDIFIER ARE TO BE VISUALLY AND FUNCTIONALLY CHECKED AND REPLACED IN THE CASE OF DAMAGE OR IF IT FAILS THE PERFORMANCE TEST.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN, VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT 900MR869 TEMPERATURE/FLOW PROBES WERE IDENTIFIED TO BE EASILY DISLODGING FROM THE PATIENT-END TEMPERATURE PROBE PORT OF FOUR RT268 INFANT EVAQUA2 BREATHING CIRCUITS DURING SET UP AND PRIOR TO PATIENT USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN, VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT 900MR869 TEMPERATURE/FLOW PROBES WERE IDENTIFIED TO BE EASILY DISLODGING FROM THE PATIENT-END TEMPERATURE PROBE PORT OF FOUR RT268 INFANT EVAQUA2 BREATHING CIRCUITS DURING SET UP AND PRIOR TO PATIENT USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540087 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE LTD RT268 SEE H11 09420012431158

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown F&P HEALTHCARE 900MR869 TEMPERATURE/FLOW PROBE.| F&P HEALTHCARE 900MR869 TEMPERATURE/FLOW PROBES.| F&P HEALTHCARE MR850GJU RESPIRATORY HUMIDIFIER.| F&P HEALTHCARE MR850GJU RESPIRATORY HUMIDIFIER.