BEUDAMED
    FDA Adverse Event Death Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 22812804 · Received August 14, 2025

    Report

    Report Number
    9611451-2025-00774
    Event Type
    Death
    Date Received
    August 14, 2025
    Date of Event
    May 24, 2025
    Report Date
    November 7, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    QAV
    PMA / PMN Number
    K221338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). [D4, H4: FISHER & PAYKEL HEALTHCARE (F&P) MADE MULTIPLE REQUESTS FOR DEVICE DETAILS FROM THE HEALTHCARE FACILITY, AND FOR THE RETURN OF THE SUBJECT AIRVO 3. HOWEVER, THE HEALTHCARE FACILITY STATED THAT THEY DID NOT RECORD THE DEVICE DETAILS OF THE SUBJECT AIRVO 3.] . 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 AIRVO 3 WAS NOT RETURNED TO F&P FOR EVALUATION. F&P MADE MULTIPLE REQUESTS FOR DEVICE DETAILS FROM THE HEALTHCARE FACILITY, AND FOR THE RETURN OF THE SUBJECT AIRVO 3. HOWEVER, THE HEALTHCARE FACILITY STATED THAT THEY DID NOT RECORD THE DEVICE DETAILS OF THE SUBJECT AIRVO 3 OR KEEP ANY OF THE SET-UP EQUIPMENT. F&P'S INVESTIGATION IS THEREFORE 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 AT APPROXIMATELY 03:59AM ON (B)(6) 2025, A NASAL CANNULA USED TO DELIVER THERAPY TO THE PATIENT WAS FOUND TO BE DISCONNECTED FROM A CIRCUIT, AND THE PATIENT'S PULSE OXIMETER PROBE WAS DETACHED FROM THE PATIENT'S FINGER. THE HEALTHCARE FACILITY ALSO STATED THAT THE SUBJECT AIRVO 3 DID NOT ALARM. THE HEALTHCARE FACILITY SUBSEQUENTLY STATED THAT THE PATIENT EXHIBITED EVIDENCE OF ANOXIC BRAN INJURY AND THE PATIENT'S FAMILY DECIDED TO PURSUE COMFORT MEASURES. IT WAS REPORTED THAT THE PATIENT DECEASED AT 17:35PM. THE HEALTHCARE FACILITY STATED THAT THE PATIENT HAD PRIOR MEDICAL CONDITIONS INCLUDING STAPHYLOCOCCUS AUREUS BACTEREMIA, OSTEOMYELITIS OF LEFT FOOT, CELLULITIS OF RIGHT UPPER EXTREMITY, CIRCULATORY SHOCK, FAILURE TO THRIVE IN ADULT, UNCONTROLLED TYPE 2 DIABETES MELLITUS WITH HYPERGLYCEMIA, ACUTE RESPIRATORY FAILURE WITH HYPOXIA AND ACUTE KIDNEY INJURY. THE HEALTHCARE FACILITY ALSO STATED THAT THE PATIENT WAS ON MEDICATIONS INCLUDING MUCOMYST AND ALBUTEROL BID. THE HEALTHCARE FACILITY ALSO STATED THAT THE PATIENT WAS AT RISK FOR ACUTE DECOMPENSATION. THE HEALTHCARE FACILITY LATER REPORTED THAT THE CAUSE OF DEATH WAS ANOXIC BRAIN INJURY DUE TO CARDIAC ARREST AND HYPOXIC RESPIRATORY FAILURE. THE HEALTHCARE FACILITY REPORTED THAT "ENVIRONMENTAL FACTORS MAY HAVE PLAYED A SIGNIFICANT ROLE". THE HEALTHCARE FACILITY ALSO STATED THAT THE HOSPITAL STAFF ON SHIFT CONFIRMED THAT LEADING UP TO AND DURING THE REPORTED EVENT, IT WAS FOUND THAT THE TUBING CONNECTION AND NASAL CANNULA FIT WAS SECURE AND IN A GOOD POSITION AT THE TIME OF THEIR LAST ASSESSMENT. THE HEALTHCARE FACILITY ALSO STATED THAT THE SUBJECT AIRVO 3 WAS INTERNALLY TESTED FOR AUDIO FUNCTIONALITY AND WAS FOUND TO WORK AS INTENDED. CONCLUSION: WITHOUT THE RETURN OF THE SUBJECT AIRVO 3 AND THE DEVICE LOG, F&P'S INVESTIGATION WAS UNABLE TO DETERMINE THE EXACT CAUSE OF THE CANNULA DISCONNECTION, AND WHETHER THE ALARM CONDITIONS OF THE SUBJECT AIRVO 3 WERE MET. THE HEALTHCARE FACILITY STATED THAT THE SUBJECT AIRVO 3 WAS INTERNALLY TESTED FOR AUDIO FUNCTIONALITY AND WAS FOUND TO WORK AS INTENDED. THE USER INSTRUCTIONS (UI) WHICH ACCOMPANY THE AIRVO 3 STATES: - "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 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."

    Additional Manufacturer Narrative · 0

    (B)(4) [D4, H4: FISHER & PAYKEL HEALTHCARE (F&P) HAS REQUESTED FOR DEVICE DETAILS. HOWEVER, THE DEVICE DETAILS HAVE NOT YET BEEN PROVIDED BY THE HEALTHCARE FACILITY.] F&P HAS REQUESTED FOR FURTHER INFORMATION FROM THE HEALTHCARE FACILITY, INCLUDING THE PATIENT CONDITION, SEQUENCE OF EVENTS, AND THE RETURN OF THE SUBJECT DEVICE. 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.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A HEALTHCARE FACILITY IN OREGON REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT ON (B)(6) 2025, A PATIENT RECEIVING THERAPY VIA A PT301US AIRVO 3 HUMIDIFIER (AIRVO 3) DECEASED. THE HEALTHCARE FACILITY STATED THAT PRIOR TO THE REPORTED EVENT, THE PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2025 FOR OSTEOMYELITIS AND BACTEREMIA REQUIRING SURGICAL INTERVENTION. THE HEALTHCARE FACILITY STATED THAT ON (B)(6) 2025 AT APPROXIMATELY 03:59AM, A NASAL CANNULA USED TO DELIVER THERAPY TO THE PATIENT WAS FOUND TO BE DISCONNECTED FROM THE CIRCUIT, AND THE PATIENT'S PULSE OXIMETER PROBE WAS DETACHED FROM THE PATIENT'S FINGER. THE HEALTHCARE FACILITY STATED THAT THE SUBJECT AIRVO 3 DID NOT ALARM. THE HEALTHCARE FACILITY FURTHER STATED THAT AT 17:35PM THE PATIENT DECEASED.

    Description of Event or Problem · 0

    ON 16 JULY 2025, A HEALTHCARE FACILITY IN OREGON REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT ON (B)(6) 2025, A PATIENT RECEIVING THERAPY VIA A PT301US AIRVO 3 HUMIDIFIER (AIRVO 3) DECEASED. THE HEALTHCARE FACILITY STATED THAT PRIOR TO THE REPORTED EVENT, THE PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2025 FOR OSTEOMYELITIS AND BACTEREMIA REQUIRING SURGICAL INTERVENTION. THE HEALTHCARE FACILITY STATED THAT ON (B)(6) 2025 AT APPROXIMATELY 03:59AM, A NASAL CANNULA USED TO DELIVER THERAPY TO THE PATIENT WAS FOUND TO BE DISCONNECTED FROM THE CIRCUIT, AND THE PATIENT'S PULSE OXIMETER PROBE WAS DETACHED FROM THE PATIENT'S FINGER. THE HEALTHCARE FACILITY STATED THAT THE SUBJECT DEVICE DID NOT ALARM. THE HEALTHCARE FACILITY FURTHER STATED THAT AT 17:35PM THE PATIENT DECEASED. F&P HAS REQUESTED FOR FURTHER INFORMATION FROM THE HEALTHCARE FACILITY, INCLUDING THE PATIENT CONDITION, DEVICE DETAILS, SEQUENCE OF EVENTS, AND THE RETURN OF THE SUBJECT DEVICE. F&P WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF F&P'S INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107501 FISHER & PAYKEL HEALTHCARE RESPIRATORY HUMIDIFIER QAV FISHER & PAYKEL HEALTHCARE LTD PT301US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| O