BEUDAMED
    FDA Adverse Event Death Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 20197649 · Received September 12, 2024

    Report

    Report Number
    9611451-2024-00655
    Event Type
    Death
    Date Received
    September 12, 2024
    Report Date
    August 13, 2024
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K131895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FISHER & PAYKEL HEALTHCARE (F&P) HAS MADE MULTIPLE REQUESTS FOR INFORMATION REGARDING THE DEVICE AND FOR THE DEVICE(S) TO BE RETURNED. NO RESPONSE HAS BEEN PROVIDED, HOWEVER, AND THE HEALTHCARE FACILITY HAS NOT RETURNED THE DEVICE(S). 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. IT'S 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(S) WERE NOT RETURNED TO F&P FOR EVALUATION. OUR INVESTIGATION HAS NECESSARILY BEEN LIMITED THEREFORE TO THE INFORMATION REPORTED BY THE HEALTHCARE FACILITY AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE HEALTHCARE FACILITY HAS STATED THAT SEVERAL YEARS AGO, DURING THE COVID-19 PANDEMIC, TWO PATIENTS WERE RECEIVING THERAPY VIA AIRVO 2 DEVICE/S AND SUBSEQUENTLY DECEASED. NO FURTHER INFORMATION REGARDING THESE REPORTED EVENTS WAS PROVIDED BY THE HEALTHCARE FACILITY. THE STAFF MEMBER FROM THE HEALTHCARE FACILITY WHO REPORTED THESE EVENTS STATED THAT THEY DID NOT SEE THESE EVENTS, WAS NOT ON SHIFT WHEN THESE EVENTS OCCURRED, AND DID NOT HAVE FIRSTHAND KNOWLEDGE OF THESE EVENTS. CONCLUSION: OUR INVESTIGATION WAS UNABLE TO CONFIRM ANY DETAILS REGARDING THE REPORTED EVENT. NO FURTHER INFORMATION REGARDING THESE REPORTED EVENTS WAS PROVIDED BY THE HEALTHCARE FACILITY. THE STAFF MEMBER FROM THE HEALTHCARE FACILITY WHO REPORTED THESE EVENTS STATED THAT THEY DID NOT SEE THESE EVENTS, WAS NOT ON SHIFT WHEN THESE EVENTS OCCURRED, AND DID NOT HAVE FIRSTHAND KNOWLEDGE OF THESE EVENTS.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT SEVERAL YEARS AGO, DURING THE COVID-19 PANDEMIC (NO DATE WAS SPECIFIED), TWO PATIENTS WERE RECEIVING THERAPY VIA F&P PT101 AIRVO 2 HUMIDIFIER AIRVO 2 (AIRVO 2) DEVICE(S) AND SUBSEQUENTLY PASSED AWAY. NO FURTHER INFORMATION REGARDING THESE REPORTED EVENTS WAS PROVIDED BY THE HEALTHCARE FACILITY. THE STAFF MEMBER FROM THE HEALTHCARE FACILITY WHO REPORTED THESE EVENTS STATED THAT THEY DID NOT SEE THESE EVENTS, WAS NOT ON SHIFT WHEN THESE EVENTS OCCURRED, AND DID NOT HAVE FIRSTHAND KNOWLEDGE OF THESE EVENTS. THIS REPORT IS RELATED TO MFR REPORT #: 9611451-2024-00656.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622333 FISHER & PAYKEL HEALTHCARE RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD PT101US NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death