BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 23069939 · Received September 16, 2025

    Report

    Report Number
    9611451-2025-00906
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Report Date
    March 18, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    QAV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4, G4: PT301IN IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA (PT301US). THE 510(K) FOR THE SIMILAR PRODUCT IS K221338. CORRECTED DATA: B4, B5, D2A, D9, E1, G3, G6, H2, H3, H6. PRODUCT BACKGROUND: THE PT301 HUMIDIFIER (AIRVO 3) IS FOR THE TREATMENT OF SPONTANEOUSLY BREATHING PATIENTS WHO WOULD BENEFIT FROM RECEIVING HIGH FLOW WARMED AND HUMIDIFIED RESPIRATORY GASES. THIS INCLUDES PATIENTS WHO HAVE HAD UPPER AIRWAYS BYPASSED. THE FLOW MAY BE FROM 2 - 70 L/MIN DEPENDING ON THE PATIENT INTERFACE. THE AIRVO 3 IS FOR PATIENTS IN HOSPITALS AND SUBACUTE FACILITIES. THE AIRVO 3 IS NOT INTENDED FOR LIFE SUPPORT. THE AIRVO 3 CAN DELIVER THESE HIGH FLOW GASES THROUGH NASAL CANNULA TO AUGMENT THE BREATHING OF SPONTANEOUSLY BREATHING NEONATE, INFANT, CHILD, ADOLESCENT AND ADULT PATIENTS SUFFERING FROM RESPIRATORY DISTRESS AND/OR HYPOXEMIA IN THE HOSPITAL SETTING. THE AIRVO 3 IS NOT INTENDED TO PROVIDE TOTAL VENTILATORY REQUIREMENTS OF THE PATIENT AND IS NOT FOR USE DURING FIELD TRANSPORT. METHOD: THE SUBJECT AIRVO 3 WAS RECEIVED BY FISHER & PAYKEL HEALTHCARE (F&P) IN NEW ZEALAND WHERE IT WAS INSPECTED BY A TRAINED F&P INVESTIGATION ENGINEER. THE DEVICE WAS PERFORMANCE TESTED AND THE AUDIBLE ALARM FUNCTION WAS CHECKED. F&P'S INVESTIGATION IS BASED ON F&P'S EVALUATION OF THE SUBJECT DEVICE, PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, F&P'S KNOWLEDGE OF THE PRODUCT, AND THE INFORMATION OBTAINED FROM THE DISTRIBUTOR. RESULTS: DURING TESTING IT WAS FOUND THAT THE AIRVO 3 DID NOT HAVE AN AUDIBLE ALARM, CONFIRMING THE REPORTED EVENT. IT WAS IDENTIFIED THAT THE ISSUE WAS DUE TO A FAULTY SPEAKER. THE SPEAKER IS A SUPPLIED COMPONENT THAT IS ASSEMBLED INTO THE AIRVO 3. THERE WAS NO PATIENT INVOLVEMENT REPORTED BY THE DISTRIBUTOR. CONCLUSION: F&P'S INVESTIGATION WAS UNABLE TO DETERMINE THE EXACT CAUSE OF THE REPORTED EVENT. BASED ON THE INFORMATION PROVIDED BY THE DISTRIBUTOR, F&P'S INVESTIGATION, AND KNOWLEDGE OF THE PRODUCT, A POSSIBLE CAUSE OF THE SPEAKER FAULT WAS DUE TO THE SPEAKER COMPONENT BEING OUT OF SPECIFICATION. THE AIRVO 3 WILL GENERATE A VISUAL ALARM IN THE PRESENCE OF AN INAUDIBLE ALARM. THE ALARM IN THE REPORTED EVENT PREVENTS THE OPERATION OF THE SUBJECT DEVICE AND ALERTS THE USER TO TAKE APPROPRIATE AND TIMELY ACTION. THERE WAS NO PATIENT INVOLVEMENT REPORTED BY THE DISTRIBUTOR. THE USER INSTRUCTIONS WHICH ACCOMPANY THE AIRVO 3 PROVIDE GUIDANCE ON TROUBLESHOOTING ALARMS GENERATED BY THE DEVICE. THE USER INSTRUCTIONS STATE THE FOLLOWING: - DEVICE FAULT (FAULT X.X.X): "A TECHNICAL FAULT HAS OCCURRED, AND THE PATIENT MAY NEED PROMPT ATTENTION. RESTART THE DEVICE TO CLEAR THE FAULT CONDITION. IF THE ISSUE PERSISTS, CONTACT YOUR SERVICE REPRESENTATIVE." THE USER INSTRUCTIONS ALSO STATE: - "MAKE SURE THE AUDITORY ALARM SIGNAL IS AUDIBLE TO THE OPERATOR WHO WILL RESPOND TO ALARMS BY FOLLOWING THE INSTRUCTIONS IN SECTION 7.5 TO TEST THE ALARM BEFORE STARTING THERAPY." - "DO NOT USE THE AIRVO 3 IF IT FAILS [THE 7.5 CHECKING THE ALARM SYSTEM] TEST. CONTACT YOUR FISHER & PAYKEL HEALTHCARE REPRESENTATIVE." - "THE AIRVO 3 IS FOR THE TREATMENT OF SPONTANEOUSLY BREATHING PATIENTS WHO WOULD BENEFIT FROM RECEIVING HIGH FLOW WARMED AND HUMIDIFIED RESPIRATORY GASES. THIS INCLUDES PATIENTS WHO HAVE HAD UPPER AIRWAY BYPASSED." - "THE AIRVO 3 IS NOT INTENDED TO PROVIDE TOTAL VENTILATORY REQUIREMENTS OF THE PATIENT AND IS NOT FOR USE DURING FIELD TRANSPORT." - "THE AIRVO 3 IS NOT INTENDED FOR LIFE SUPPORT. DO NOT USE AIRVO 3 ON PATIENTS WHO CANNOT TOLERATE A BRIEF INTERRUPTION OF THERAPY." - "APPROPRIATE PATIENT MONITORING IS REQUIRED FOR ALL PATIENTS USING THE AIRVO 3."

    Additional Manufacturer Narrative · 0

    (B)(4). D4, G4: PT301IN IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA (PT301US). THE 510(K) FOR THE SIMILAR PRODUCT IS K221338. FISHER & PAYKEL HEALTHCARE (F&P) HAS REQUESTED FOR THE COMPLAINT DEVICE TO BE RETURNED FOR EVALUATION. F&P WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF F&P'S INVESTIGATION. PRODUCT BACKGROUND: THE PT301 HUMIDIFIER (AIRVO 3) IS FOR THE TREATMENT OF SPONTANEOUSLY BREATHING PATIENTS WHO WOULD BENEFIT FROM RECEIVING HIGH FLOW WARMED AND HUMIDIFIED RESPIRATORY GASES. THIS INCLUDES PATIENTS WHO HAVE HAD UPPER AIRWAYS BYPASSED. THE FLOW MAY BE FROM 2 - 70 L/MIN DEPENDING ON THE PATIENT INTERFACE. THE AIRVO 3 IS FOR PATIENTS IN HOSPITALS AND SUBACUTE FACILITIES. THE AIRVO 3 IS NOT INTENDED FOR LIFE SUPPORT. THE AIRVO 3 CAN DELIVER THESE HIGH FLOW GASES THROUGH NASAL CANNULA TO AUGMENT THE BREATHING OF SPONTANEOUSLY BREATHING NEONATE, INFANT, CHILD, ADOLESCENT AND ADULT PATIENTS SUFFERING FROM RESPIRATORY DISTRESS AND/OR HYPOXEMIA IN THE HOSPITAL SETTING. THE AIRVO 3 IS NOT INTENDED TO PROVIDE TOTAL VENTILATORY REQUIREMENTS OF THE PATIENT AND IS NOT FOR USE DURING FIELD TRANSPORT.

    Description of Event or Problem · 0

    A DISTRIBUTOR IN INDIA REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT A PT301 HUMIDIFIER (AIRVO 3) GENERATED A VISUAL ALARM. THE NATURE OF THE VISUAL ALARM SUGGESTS THERE MAY BE A POTENTIAL ISSUE WITH THE SUBJECT DEVICE'S AUDIBLE ALARM. DURING DEVICE EVALUATION AT THE FISHER & PAYKEL HEALTHCARE (F&P) REGIONAL OFFICE IN INDIA, IT WAS FOUND THAT THERE WAS NO AUDIBLE ALARM. 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 IN INDIA VIA A FISHER AND PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT A PT301 HUMIDIFIER (AIRVO 3) GENERATED AN ALARM. THE NATURE OF THE ALARM SUGGESTS THERE MAY BE A POTENTIAL ISSUE WITH THE SUBJECT DEVICE'S AUDIBLE ALARM. DURING DEVICE EVALUATION AT THE FISHER & PAYKEL HEALTHCARE (F&P) REGIONAL OFFICE IN INDIA, IT WAS FOUND THAT THERE WAS NO AUDIBLE ALARM. 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
    1648099 FISHER & PAYKEL HEALTHCARE HIGH FLOW HUMIDIFIED OXYGEN DELIVERY DEVICE QAV FISHER & PAYKEL HEALTHCARE LTD PT301IN 2103735918

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown