BEUDAMED
    FDA Adverse Event Death Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 21382968 · Received February 14, 2025

    Report

    Report Number
    9611451-2025-00137
    Event Type
    Death
    Date Received
    February 14, 2025
    Date of Event
    January 16, 2025
    Report Date
    January 16, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    UDI-DI
    09420012422323
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). [D4,G4: PT101JP 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) HAS REQUESTED FOR THE PT101 AIRVO 2 HUMIDIFIER (AIRVO 2) TO BE RETURNED FOR EVALUATION AND IS SEEKING FURTHER INFORMATION FROM THE HEALTHCARE FACILITY. 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. 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.

    Additional Manufacturer Narrative · 0

    (B)(4) [CORRECTED DATA: B5,D9,G3,G6,H1,H2,H3,H6] [D4,G4: PT101JP 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: THE SUBJECT DEVICE WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE (F&P) IN NEW ZEALAND WHERE IT WAS INSPECTED BY A TRAINED F&P INVESTIGATION ENGINEER. F&P'S INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY, F&P'S EVALUATION OF THE SUBJECT DEVICE, PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, AND F&P'S KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION OF THE SUBJECT DEVICE REVEALED NO SIGNS OF EXTERNAL DAMAGE. THE HEALTHCARE FACILITY STATED THAT THE PATIENT STARTED THERAPY ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT WAS TRANSFERRED FROM THE ICU TO THE HOSPITAL WARD. IT WAS REPORTED THAT ON (B)(6) 2025, THE AIRVO 2 GENERATED AN ALARM AT 12:31AM AND THE PATIENT'S SPO2 DECREASED TO 94%. IT WAS REPORTED THAT THE SUBJECT DEVICE WAS THEN REPLACED. IT WAS FURTHER REPORTED BY THE HEALTHCARE FACILITY THAT ON (B)(6) 2025 THE PATIENT PASSED FROM SEPTIC SHOCK WITH HEMORRHAGIC SHOCK AS THE MEDICAL CAUSE OF DEATH. CONCLUSION: ON THE BASIS OF THE REPORTED INFORMATION, THERE IS NO CONCLUSIVE EVIDENCE OF A CAUSAL RELATIONSHIP BETWEEN THE PATIENT DEATH, AND THE SUBJECT DEVICE. 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 USER INSTRUCTIONS WHICH ACCOMPANY THE AIRVO 2 PROVIDE GUIDANCE ON TROUBLESHOOTING ALARMS GENERATED BY THE DEVICE. THE USER INSTRUCTIONS ALSO STATE THE FOLLOWING: "ALARM CONDITIONS THAT AFFECT OXYGEN DELIVERY REQUIRE AN IMMEDIATE RESPONSE TO ASSESS THE PATIENT'S SATURATION LEVELS" "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." "APPROPRIATE PATIENT MONITORING MUST BE USED AT ALL TIMES" "NEVER OPERATE THE UNIT IF IT IS NOT WORKING PROPERLY" "NEVER OPERATE THE UNIT IF IT HAS BEEN DROPPED OR DAMAGED".

    Description of Event or Problem · 0

    ON 16 JANUARY 2025, A DISTRIBUTOR IN JAPAN REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT A PT101 AIRVO 2 HUMIDIFIER (AIRVO 2) GENERATED AN ALARM DURING PATIENT USE. THE HEALTHCARE FACILITY ALSO REPORTED THAT THE PATIENT'S SPO2 DECREASED AND A DEVICE WAS REPLACED. IT WAS FURTHER REPORTED THAT THE PATIENT LATER DECEASED AFTER AN UNSPECIFIED PERIOD OF TIME. FISHER & PAYKEL HEALTHCARE (F&P) HAS REQUESTED FOR THE AIRVO 2 DEVICE TO BE RETURNED FOR EVALUATION AND IS SEEKING FURTHER INFORMATION FROM THE HEALTHCARE FACILITY. F&P WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    ON 16 JANUARY 2025, A DISTRIBUTOR IN JAPAN REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT A PT101 AIRVO 2 HUMIDIFIER (AIRVO 2) GENERATED AN ALARM DURING PATIENT USE. FURTHER INFORMATION PROVIDED BY THE HEALTHCARE FACILITY ON 18 FEBRUARY 2025 STATED THAT THE PATIENT STARTED THERAPY ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT WAS TRANSFERRED FROM THE ICU TO THE HOSPITAL WARD. IT WAS REPORTED THAT ON (B)(6) 2025, THE AIRVO 2 GENERATED AN ALARM AT 12:31AM AND THE PATIENT'S SPO2 DECREASED TO 94%. IT WAS REPORTED THAT THE SUBJECT DEVICE WAS THEN REPLACED. IT WAS FURTHER REPORTED BY THE HEALTHCARE FACILITY THAT ON (B)(6) 2025 THE PATIENT PASSED FROM SEPTIC SHOCK WITH HEMORRHAGIC SHOCK AS THE MEDICAL CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982338 FISHER & PAYKEL HEALTHCARE RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD PT101EW 2101643111 09420012422323

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other F&P OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTI| F&P OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTI