BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 23835225 · Received December 17, 2025

    Report

    Report Number
    9611451-2025-02171
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Report Date
    April 2, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    UDI-DI
    09420012422286
    Removal / Correction Number
    9611451-09/10/2025-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4,G4: PT101EW 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. FISHER & PAYKEL HEALTHCARE (F&P) IS CURRENTLY IN THE PROCESS OF COMPLETING F&P'S INVESTIGATION. F&P WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF F&P'S INVESTIGATION. PRODUCT BACKGROUND: THE PT101 AIRVO 2 HUMIDIFIER (AIRVO 2) 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 IS NOT INTENDED FOR LIFE SUPPORT, AND APPROPRIATE PATIENT MONITORING MUST BE USED AT ALL TIMES.

    Additional Manufacturer Narrative · 0

    (B)(6). CORRECTED DATA: B4, B5, D9, G2, G3, G6, H2, H6, H11. D4,G4: PT101EW 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 HUMIDIFIER (AIRVO 2) 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 IS NOT INTENDED FOR LIFE SUPPORT, AND APPROPRIATE PATIENT MONITORING MUST BE USED AT ALL TIMES. METHOD: THE SUBJECT AIRVO 2 WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (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 HAS STATED THAT THE POWER OUT ALARM OF THE SUBJECT AIRVO 2 SOUNDED FOR LESS THAN 120 SECONDS. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT. CONCLUSION: BASED ON F&P'S INVESTIGATION, KNOWLEDGE OF THE PRODUCT, AND PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, THE POWER OUT ALARM OF THE SUBJECT AIRVO 2 SOUNDING FOR LESS THAN 120 SECONDS IS LIKELY DUE TO THE AGING OF COMPONENT SUPERCAPACITORS. A REVIEW OF ALL-TIME COMPLAINT DATA HAS CONFIRMED THAT GLOBALLY THERE HAVE BEEN NO EVENTS WITH SERIOUS INJURY OR DEATH RELATED TO THE POWER OUT ALARM SOUNDING FOR LESS THAN 120 SECONDS. F&P'S INVESTIGATION FOUND IT LIKELY THAT DURING THE COVID-19 PANDEMIC, AIRVO 2 DEVICES WERE KEPT CONTINUOUSLY CONNECTED TO MAINS POWER TO ENSURE IMMEDIATE AVAILABILITY, GIVEN THE URGENCY AND UNPREDICTABILITY OF RESPIRATORY DETERIORATION IN COVID-19 PATIENTS. THIS PRACTICE ALIGNS WITH HOSPITAL PROTOCOLS, WHICH EMPHASIZE READINESS AND RAPID DEPLOYMENT OF RESPIRATORY SUPPORT EQUIPMENT IN HIGH-ACUITY SETTINGS. THE ORIGINAL LIFE TESTING CARRIED OUT ON AIRVO 2 DEVICES ASSUMED THAT THE DEVICES WERE DISCONNECTED FROM MAINS BETWEEN THERAPY SESSIONS AND AS PRACTICES HAVE EVOLVED, THIS NO LONGER REFLECTS REAL WORLD USAGE PATTERNS, PARTICULARLY DURING PANDEMIC CONDITIONS WHEN DEVICE AVAILABILITY WAS CRITICAL AND SINCE CLINICAL PRACTICES HAVE SHIFTED. F&P'S INVESTIGATION ALSO ASSESSED THE MANUFACTURING CONTROLS AND DETERMINED THEY WERE SUFFICIENT AND ADEQUATE. IN ADDITION, AS THE ROOT CAUSE POINTED TO USAGE IN FIELD, NO FURTHER CHANGES TO THE MANUFACTURING OR SUPPLIER PROCESSES WAS DEEMED NECESSARY. 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 IS REJECTED. F&P HAVE UPDATED TEST PROTOCOLS TO SPECIFY THAT TEST DEVICES BE POWERED 24 HOURS A DAY I.E. WORST-CASE, AND F&P EXPECT THIS CHANGE TO COVER ANY FURTHER UNEXPECTED OPERATIONAL DEVIATIONS OR UNANTICIPATED CHANGES IN USAGE PATTERNS. THIS UPDATE TO F&P'S TEST PROTOCOLS WILL BE USED IN ANY NEW DEVELOPMENT OR CHANGE TO THE DEVICE. FURTHERMORE, AN UPDATE TO THE DISINFECTION KIT USER MANUAL OF THE AIRVO 2 WAS MADE TO INCLUDE A REGULAR TEST OF THE POWER OUT ALARM, TO BE CARRIED OUT IN BETWEEN EACH PATIENT USE. THIS CHANGE WAS COMMUNICATED TO USERS THROUGH A VOLUNTARY FIELD SAFETY NOTICE IN SEPTEMBER 2025. IN RESPONSE TO THIS CHANGE, CUSTOMERS ARE CONDUCTING THE REGULAR TEST IN BETWEEN PATIENT USE AND REPORTING ANY FAILURES. THE USER INSTRUCTION (UI) OF THE AIRVO 2 HUMIDIFIER STATES: - "IF EITHER ALARM SIGNAL IS ABSENT, DO NOT USE THE UNIT. CONTACT YOUR FISHER & PAYKEL HEALTHCARE REPRESENTATIVE." - "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."

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN ITALY REPORTED THAT THE POWER OUT ALARM OF THE PT101 AIRVO 2 HUMIDIFIER (AIRVO 2) SOUNDED FOR LESS THAN 120 SECONDS. THIS WAS FOUND WHILE THE SUBJECT AIRVO 2 WAS OUT OF USE AND NOT ON A PATIENT. THIS WAS REPORTED SUBSEQUENT TO A FIELD SAFETY NOTICE INFORMING USERS OF A CHANGE TO THE DISINFECTION KIT USER MANUAL OF THE AIRVO 2 TO INCLUDE A REGULAR TEST OF THE POWER OUT ALARM, TO BE CARRIED OUT IN BETWEEN EACH PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN ITALY VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE POWER OUT ALARM OF THE PT101 AIRVO 2 HUMIDIFIER (AIRVO 2) SOUNDED FOR LESS THAN 120 SECONDS. THIS WAS FOUND WHILE THE SUBJECT AIRVO 2 WAS OUT OF USE AND NOT ON A PATIENT. THIS WAS REPORTED SUBSEQUENT TO A FIELD SAFETY NOTICE INFORMING USERS OF A CHANGE TO THE DISINFECTION KIT USER MANUAL OF THE AIRVO 2 TO INCLUDE A REGULAR TEST OF THE POWER OUT ALARM, TO BE CARRIED OUT IN BETWEEN EACH PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113600 FISHER & PAYKEL HEALTHCARE RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD PT101EW 2101400421 09420012422286

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown