BEUDAMED
    FDA Adverse Event Death Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 22857415 · Received August 20, 2025

    Report

    Report Number
    9611451-2025-00793
    Event Type
    Death
    Date Received
    August 20, 2025
    Date of Event
    July 18, 2025
    Report Date
    August 21, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    UDI-DI
    09420012422354102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D1, G4: PT101UK IS NOT SOLD IN THE USA BUT IS SIMILAR TO THE PT101US WHICH IS SOLD IN THE USA. THE 510K OF THE PT101US IS: K131895, PRODUCT CODE: BTT. PRODUCT BACKGROUND: THE PT101 AIRVO 2 HUMIDIFIER (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. 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 DEVICE SHOULD NOT BE USED FOR LIFE SUPPORT PURPOSES, AND APPROPRIATE PATIENT MONITORING MUST BE USED AT ALL TIMES. METHOD: THE SUBJECT AIRVO 2 DEVICE WAS NOT RETURNED TO F&P FOR EVALUATION. OUR INVESTIGATION HAS NECESSARILY BEEN LIMITED THEREFORE TO THE INFORMATION REPORTED AND PROVIDED BY THE HEALTHCARE FACILITY AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE HEALTHCARE FACILITY REPORTED THAT THE POWER PLUG OF THE SUBJECT DEVICE WAS INADVERTENTLY DISCONNECTED FROM THE HEALTHCARE FACILITY'S WALL SOCKET DUE TO A NURSING ERROR. IT WAS REPORTED BY THE HEALTHCARE FACILITY THAT A FUNCTIONALITY TEST WAS PERFORMED ON THE SUBJECT DEVICE AT THE HEALTHCARE FACILITY BY A TRAINED TECHNICIAN ON THE 21ST OF JULY 2025, AND THAT THE SUBJECT DEVICE PASSED ALL F&P PERFORMANCE CHECKS AND WAS CONFIRMED TO BE OPERATIONAL. F&P MADE REQUESTS FOR DEVICE AND EVENT DETAILS TO THE HEALTHCARE FACILITY, HOWEVER THE HEALTHCARE FACILITY STATED THAT THE FUNCTIONALITY OF THE DEVICE WAS CONFIRMED TO BE OPERATIONAL AND DID NOT PROVIDE INFORMATION IN RESPONSE TO THESE REQUESTS NOR AGREE TO RETURN THE SUBJECT DEVICE TO F&P FOR EVALUATION. THE DEVICE LOGS WERE RETRIEVED FROM THE SUBJECT DEVICE AND INSPECTED BY A TRAINED F&P INVESTIGATION ENGINEER. THE DEVICE LOG FILES RECORDED THAT THERAPY DELIVERY ASSOCIATED WITH THE REPORTED EVENT BEGAN ON THE (B)(6) 2025. THE DATA LOGS RECORDED THAT A SHUTDOWN OF THE SUBJECT DEVICE WAS RECORDED ON THE (B)(6) 2025, BETWEEN APPROXIMATELY 10:57AM AND 11:02AM. THE DATA LOGS RECORDED THAT THE SUBJECT DEVICE WAS POWERED ON AGAIN ON THE (B)(6) 2025 AT APPROXIMATELY 11:22AM. THE REVIEW OF THE DATA LOGS SHOWED THERE WERE NO FAULTS OR ERRORS RECORDED IN THE SUBJECT DEVICE NEAR THE TIME OF THE REPORTED EVENT. CONCLUSION: F&P'S INVESTIGATION DID NOT IDENTIFY ANY FAULTS OR ERRORS WITH THE SUBJECT DEVICE. THE HEALTHCARE FACILITY REPORTED THAT THE POWER PLUG OF THE SUBJECT DEVICE WAS INADVERTENTLY DISCONNECTED FROM THE HEALTHCARE FACILITY'S WALL SOCKET DUE TO A NURSING ERROR. THE HEALTHCARE FACILITY REPORTED THAT A FUNCTIONALITY TEST WAS PERFORMED ON THE SUBJECT DEVICE AT THE HEALTHCARE FACILITY BY A TRAINED TECHNICIAN, AND THAT THE SUBJECT DEVICE PASSED ALL F&P PERFORMANCE CHECKS AND WAS CONFIRMED TO BE OPERATIONAL. F&P MADE REQUESTS FOR DEVICE AND EVENT DETAILS, HOWEVER THE HEALTHCARE FACILITY STATED THAT THE FUNCTIONALITY OF THE DEVICE WAS CONFIRMED TO BE OPERATIONAL AND DID NOT PROVIDE INFORMATION IN RESPONSE TO THESE REQUESTS NOR AGREE TO RETURN THE SUBJECT DEVICE TO F&P FOR EVALUATION. THE USER INSTRUCTION (UI) OF THE PT101 AIRVO 2 HUMIDIFIER STATES: - "APPROPRIATE PATIENT MONITORING MUST BE USED AT ALL TIMES. LOSS OF POWER MEANS LOSS OF THERAPY." - "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."

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN HONG KONG REPORTED THAT ON (B)(6) 2025, BETWEEN APPROXIMATELY 10AM AND 11AM, THE POWER PLUG OF A PT101 AIRVO 2 HUMIDIFIER WAS INADVERTENTLY DISCONNECTED FROM THE HEALTHCARE FACILITY'S WALL SOCKET DUE TO A NURSING ERROR. THE HEALTHCARE FACILITY REPORTED THAT THE PATIENT SUBSEQUENTLY DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466006 FISHER & PAYKEL HEALTHCARE RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD PT101UK 2101802876 09420012422354102

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death