BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 23930476 · Received December 30, 2025

    Report

    Report Number
    9611451-2025-02267
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Report Date
    April 6, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    QAV
    PMA / PMN Number
    K221338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4, H4: COMPLETE DEVICE IDENTIFICATION INFORMATION HAS BEEN REQUESTED FROM THE HEALTHCARE FACILITY. FISHER & PAYKEL HEALTHCARE (F&P) HAS REQUESTED FOR THE SUBJECT DEVICE TO BE RETURNED FOR EVALUATION. F&P WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF F&P'S INVESTIGATION. PRODUCT BACKGROUND: THE PT301US 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.

    Additional Manufacturer Narrative · 0

    (B)(6). D4, H4: COMPLETE DEVICE IDENTIFICATION INFORMATION WAS NOT PROVIDED BY THE HEALTHCARE FACILITY. PRODUCT BACKGROUND: THE PT301US 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 POWER CORD AS PART OF THE PT301US AIRVO 3 HUMIDIFIER 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 SUBJECT POWER CORD WAS FRAYED. FISHER & PAYKEL HEALTHCARE (F&P) REQUESTED FOR FURTHER INFORMATION REGARDING THE REPORTED EVENT, HOWEVER, NO RESPONSE WAS PROVIDED BY THE HEALTHCARE FACILITY. THERE WAS NO REPORTED PATIENT INVOLVEMENT. CONCLUSION: WITHOUT THE RETURN OF THE SUBJECT POWER CORD, F&P ARE UNABLE TO CONFIRM THE EXACT CAUSE OF THE REPORTED EVENT. THE USER INSTRUCTIONS (UI) WHICH ACCOMPANY THE AIRVO 3 STATES: - "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 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." - "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 HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE POWER CORD AS PART OF THE PT301US AIRVO 3 HUMIDIFIER HAD FRAYED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN CALIFORNIA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE POWER CORD AS PART OF THE PT301US AIRVO 3 HUMIDIFIER HAD FRAYED. FISHER & PAYKEL HEALTHCARE (F&P) REQUESTED FOR FURTHER INFORMATION REGARDING THE REPORTED EVENT, HOWEVER, NO RESPONSE WAS PROVIDED BY THE HEALTHCARE FACILITY. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399695 FISHER & PAYKEL HEALTHCARE HIGH FLOW HUMIDIFIED OXYGEN DELIVERY DEVICE QAV FISHER & PAYKEL HEALTHCARE LTD PT301US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown