BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 23012943 · Received September 10, 2025

    Report

    Report Number
    9611451-2025-00877
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    July 28, 2025
    Report Date
    September 10, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). D4, G4: PT101AZ IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA (PT101US). THE 510(K) FOR THE SIMILAR PRODUCT IS K131895. PRODUCT BACKGROUND: THE PT101 AIRVO 2 (AIRVO 2) DEVICE IS AN ACTIVE HUMIDIFIER WITH INTEGRATED FLOW GENERATOR THAT DELIVERS HIGH FLOW WARMED AND HUMIDIFIED RESPIRATORY GASES TO SPONTANEOUSLY BREATHING PATIENTS THROUGH A VARIETY OF PATIENT INTERFACES. IT'S INTENDED USE IS FOR THE TREATMENT OF SPONTANEOUSLY BREATHING PATIENTS WHO WOULD BENEFIT FROM RECEIVING HIGH FLOW WARMED AND HUMIDIFIED RESPIRATORY GASES. THE AIRVO 2 DEVICE SHOULD NOT BE USED FOR LIFE SUPPORT PURPOSES, AND APPROPRIATE PATIENT MONITORING MUST BE USED AT ALL TIMES. METHOD: THE SUBJECT DEVICE WAS NOT RETURNED TO F&P FOR EVALUATION. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE HEALTHCARE FACILITY REPORTED THAT AFTER ADJUSTING THE SUBJECT DEVICE'S SETTINGS, THE PATIENT'S OXYGEN SATURATION LEVELS DECREASED TO 76%. DESPITE F&P'S MULTIPLE REQUESTS FOR FURTHER INFORMATION REGARDING THE EVENT, THE REQUESTED INFORMATION WAS NOT PROVIDED. CONCLUSION: ON THE BASIS OF THE LIMITED INFORMATION AVAILABLE AND THE DATE OF THE REPORTED EVENT, F&P'S INVESTIGATION WAS UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. DURING THE MANUFACTURING PROCESS, QUALITY CONTROL MEASURES ENSURE EACH MANUFACTURED AIRVO 2 MEETS SPECIFICATION. THESE QUALITY CONTROL MEASURES ARE PERFORMED AT THE END OF THE FINAL ASSEMBLY PROCESS ON 100% OF THE MANUFACTURED UNITS. ANY UNIT THAT FAILS ANY OF THESE TESTS WILL BE REJECTED. THE SUBJECT DEVICE THEREFORE WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. THE AIRVO 2 UI ALSO PROVIDES THE FOLLOWING WARNINGS: "THE UNIT IS NOT INTENDED FOR LIFE SUPPORT." "APPROPRIATE PATIENT MONITORING MUST BE USED AT ALL TIMES. LOSS OF POWER MEANS LOSS OF THERAPY." "USE CONTINUOUS OXYGEN MONITORING ON PATIENTS WHO WOULD DESATURATE SIGNIFICANTLY IN THE EVENT OF DISRUPTION TO THEIR OXYGEN SUPPLY." "NEVER OPERATE THE UNIT IF IT IS NOT WORKING PROPERLY."

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN CHINA REPORTED THAT ON (B)(6) 2025, A PATIENT WAS ADMINISTERED THERAPY ON A PT101 AIRVO 2 RESPIRATORY HUMIDIFIER (AIRVO 2). IT WAS REPORTED BY THE HEALTHCARE FACILITY THAT AFTER ADJUSTING THE SUBJECT DEVICE'S SETTINGS, THE PATIENT'S OXYGEN SATURATION LEVELS DECREASED TO 76%. IT WAS REPORTED THAT THE PATIENT WAS THEN MOVED ON TO A VENTILATOR. THERE WAS NO FURTHER PATIENT CONSEQUENCES REPORTED. FISHER AND PAYKEL HEALTHCARE (F&P) MADE MULTIPLE REQUESTS FOR FURTHER INFORMATION SUCH AS DETAILS ON THE SEQUENCE OF EVENTS AND PATIENT INFORMATION; HOWEVER, THE REQUESTED INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1952385 FISHER & PAYKEL HEALTHCARE RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD PT101AZ 2102454027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other