BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 21639289 · Received March 19, 2025

    Report

    Report Number
    9611451-2025-00239
    Event Type
    Injury
    Date Received
    March 19, 2025
    Date of Event
    December 9, 2019
    Report Date
    February 17, 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)(4). 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. THE PRODUCT CODE AND SERIAL NUMBER INITIALLY PROVIDED BY THE HEALTHCARE FACILITY WERE NOT VALID DETAILS THAT ARE ASSOCIATED WITH THE AIRVO 2. DEVICE DETAILS SUCH AS SERIAL NUMBER, LOT NUMBER, AND UDI WERE UNABLE TO BE OBTAINED BY THE HEALTHCARE FACILITY. 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 FISHER & PAYKEL HEALTHCARE (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 THE SUBJECT DEVICE WAS NOT DELIVERING THERAPY. DESPITE F&P'S REQUEST 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: "APPROPRIATE PATIENT MONITORING MUST BE USED AT ALL TIMES. LOSS OF POWER MEANS LOSS OF THERAPY." "THE UNIT IS NOT INTENDED FOR LIFE SUPPORT." "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 4 DECEMBER 2019, A PATIENT BEGAN THERAPY ON A FISHER & PAYKEL HEALTHCARE (F&P) PT101 AIRVO 2 RESPIRATORY HUMIDIFIER (AIRVO 2) WHILST MAINTAINING AN OXYGEN SATURATION LEVEL AT APPROXIMATELY 90% SPO2. ON 9 DECEMBER 2019, IT WAS REPORTED THAT THE AIRVO 2 GENERATED AN ALARM, AND THE AIRVO 2 WAS NO LONGER DELIVERING THERAPY. THE PATIENT'S OXYGEN SATURATION LEVELS DECREASED TO 39% SPO2. THE HEALTHCARE FACILITY REPORTED THAT THE PATIENT WAS THEN IMMEDIATELY PROVIDED WITH NON-INVASIVE VENTILATOR SUPPORT, AND THE PATIENT'S OXYGEN SATURATION LEVELS RECOVERED. FURTHER INFORMATION SUCH AS EXACT LEVELS OF SPO2, CLARIFICATION ON THE REPORTED FAULT INCLUDING DETAILS OF THE ALARM GENERATED AND CURRENT PATIENT CONDITION WERE REQUESTED FROM THE HEALTHCARE FACILITY; HOWEVER, THE REQUESTED INFORMATION WAS NOT PROVIDED. THE PRODUCT CODE AND SERIAL NUMBER INITIALLY PROVIDED BY THE HEALTHCARE FACILITY WERE NOT VALID DETAILS THAT ARE ASSOCIATED WITH THE AIRVO 2. DEVICE DETAILS SUCH AS SERIAL NUMBER, LOT NUMBER, AND UDI WERE UNABLE TO BE OBTAINED BY THE HEALTHCARE FACILITY. THERE WAS NO FURTHER PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186267 FISHER & PAYKEL HEALTHCARE RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD PT101AZ NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other