BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 20575423 · Received October 30, 2024

    Report

    Report Number
    9611451-2024-00781
    Event Type
    Injury
    Date Received
    October 30, 2024
    Report Date
    October 1, 2024
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    UDI-DI
    09420012422286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). [CORRECTED DATA: B5,D1,G3,G6,H2,H6]. [D4, H10: PT101AN IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K131895.]. PRODUCT BACKGROUND: THE 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: FISHER & PAYKEL HEALTHCARE (F&P) REQUESTED THE RETURN OF THE SUBJECT DEVICE, HOWEVER, THE SUBJECT DEVICE WAS NOT RETURNED TO F&P FOR EVALUATION. F&P ALSO REQUESTED FURTHER INFORMATION ABOUT THE REPORTED EVENT, INCLUDING INFORMATION ABOUT THE PATIENT CONDITION, SEQUENCE OF EVENTS AND THE REPORTED FAULT WITH THE SUBJECT DEVICE. HOWEVER, NO FURTHER INFORMATION WAS PROVIDED. F&P'S INVESTIGATION IS THEREFORE BASED ON THE LIMITED INFORMATION PROVIDED BY THE HEALTHCARE FACILITY, PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, AND F&P'S KNOWLEDGE OF THE PRODUCT. RESULTS: THE HEALTHCARE FACILITY STATED THAT THE SUBJECT DEVICE WAS INVOLVED IN A PATIENT DESATURATION. DESPITE F&P'S REQUESTS FOR FURTHER INFORMATION REGARDING THE EVENT, NO FURTHER INFORMATION WAS PROVIDED. CONCLUSION: ON THE BASIS OF THE LIMITED INFORMATION AVAILABLE, 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."

    Additional Manufacturer Narrative · 0

    (B)(4). [D4, H10: PT101AN IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K131895.] PRODUCT BACKGROUND: THE 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. ITS 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: FISHER & PAYKEL HEALTHCARE (F&P) REQUESTED THE RETURN OF THE SUBJECT DEVICE; HOWEVER, THE SUBJECT DEVICE WAS NOT RETURNED TO F&P FOR EVALUATION. F&P'S INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY, PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, AND F&P'S KNOWLEDGE OF THE PRODUCT. RESULTS: THE HEALTHCARE FACILITY STATED THAT THE SUBJECT DEVICE WAS INVOLVED IN A PATIENT DESATURATION. DESPITE F&P'S REQUESTS FOR FURTHER INFORMATION REGARDING THE EVENT, NO FURTHER INFORMATION WAS PROVIDED AS AT 19 DECEMBER 2024. HOWEVER, ON 29 APRIL 2025, THE HEALTHCARE FACILITY SUBSEQUENTLY PROVIDED ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT. THE HEALTHCARE FACILITY STATED THAT UPON DETECTION, THE SUBJECT DEVICE WAS NOT DELIVERING THE FLOW AT THE SET RATE. IT WAS REPORTED THAT THE HOSPITAL STAFF TRIED TO RESET THE SUBJECT DEVICE, BUT IT DID NOT WORK AND THE SUBJECT DEVICE WAS THEN REPLACED. THE HEALTHCARE FACILITY REPORTED THAT THE PATIENT HAD AN OXYGEN SATURATION OF 75%. F&P THEN REQUESTED FURTHER CLARIFICATION ABOUT THE REPORTED EVENT FOLLOWING THE RECEIPT OF THE ADDITIONAL INFORMATION. F&P REQUESTED INFORMATION INCLUDING THE PATIENT CONDITION, SEQUENCE OF EVENTS AND THE REPORTED FAULT WITH THE SUBJECT DEVICE. HOWEVER, NO FURTHER CLARIFICATION WAS PROVIDED BY THE HEALTHCARE FACILITY. CONCLUSION: ON THE BASIS OF THE LIMITED INFORMATION AVAILABLE, 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 USER INSTRUCTIONS 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."

    Additional Manufacturer Narrative · 0

    (B)(4). PT101AN IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K131895. FISHER & PAYKEL HEALTHCARE (F&P) HAVE REQUESTED THAT THE SUBJECT DEVICE BE RETURNED FOR INVESTIGATION. F&P WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION. PRODUCT BACKGROUND: THE 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. ITS 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.

    Description of Event or Problem · 0

    ON 01 OCTOBER 2024, A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN ITALY VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT A PT101 AIRVO 2 HUMIDIFIER WAS INVOLVED IN A PATIENT DESATURATION. THE LEVEL WAS OF DESATURATION WAS NOT PROVIDED. F&P REQUESTED ON MORE THAN ONE OCCASION FURTHER INFORMATION ABOUT THE REPORTED EVENT, INCLUDING INFORMATION ABOUT THE PATIENT CONDITION, SEQUENCE OF EVENTS AND THE REPORTED FAULT WITH THE SUBJECT DEVICE. HOWEVER, NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    ON 01 OCTOBER 2024, A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN ITALY VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT A PT101 AIRVO 2 HUMIDIFIER WAS INVOLVED IN A PATIENT DESATURATION. THE LEVEL WAS OF DESATURATION WAS NOT PROVIDED. F&P REQUESTED ON MORE THAN ONE OCCASION FURTHER INFORMATION ABOUT THE REPORTED EVENT, INCLUDING INFORMATION ABOUT THE PATIENT CONDITION, SEQUENCE OF EVENTS AND THE REPORTED FAULT WITH THE SUBJECT DEVICE. HOWEVER, NO FURTHER INFORMATION WAS PROVIDED AS AT 19 DECEMBER 2024. HOWEVER, ON 29 APRIL 2025, THE HEALTHCARE FACILITY SUBSEQUENTLY PROVIDED ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT. THE HEALTHCARE FACILITY STATED THAT UPON DETECTION, THE SUBJECT DEVICE WAS NOT DELIVERING THE FLOW AT THE SET RATE. IT WAS REPORTED THAT THE HOSPITAL STAFF TRIED TO RESET THE SUBJECT DEVICE, BUT IT DID NOT WORK AND THE SUBJECT DEVICE WAS THEN REPLACED. THE HEALTHCARE FACILITY REPORTED THAT THE PATIENT HAD AN OXYGEN SATURATION OF 75%. F&P THEN REQUESTED FURTHER CLARIFICATION ABOUT THE REPORTED EVENT FOLLOWING THE RECEIPT OF THE ADDITIONAL INFORMATION. F&P REQUESTED INFORMATION INCLUDING THE PATIENT CONDITION, SEQUENCE OF EVENTS AND THE REPORTED FAULT WITH THE SUBJECT DEVICE. HOWEVER, NO FURTHER CLARIFICATION WAS PROVIDED BY THE HEALTHCARE FACILITY.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN ITALY VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT A PT101 AIRVO 2 HUMIDIFIER WAS INVOLVED IN A PATIENT DESATURATION. THE LEVEL WAS OF DESATURATION WAS NOT PROVIDED. F&P HAVE REQUESTED FURTHER INFORMATION ABOUT THE REPORTED EVENT, INCLUDING INFORMATION ABOUT THE PATIENT CONDITION, SEQUENCE OF EVENTS AND THE REPORTED FAULT WITH THE SUBJECT AIRVO 2 DEVICE. HOWEVER, NO FURTHER INFORMATION WAS PROVIDED. F&P WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2010962 FISHER & PAYKEL HEALTHCARE RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD PT101EW 2101423940 09420012422286

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other