BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 23034832 · Received September 12, 2025

    Report

    Report Number
    9611451-2025-00871
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Report Date
    October 16, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    UDI-DI
    09420012477453
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: THE RD065 NEOPUFF SPARE MANOMETER KIT IS AN ACCESSORY OF RD900AEU WHICH IS SOLD IN THE UNITED STATES OF AMERICA (USA). THE 510(K) OF THE RD900AEU IS K971695. METHOD: THE SUBJECT DEVICE RD065 NEOPUFF SPARE MANOMETER KIT WAS RETURNED TO OUR FISHER & PAYKEL HEALTHCARE (F&P) NEW ZEALAND, WHERE IT WAS VISUALLY INSPECTED, AND PERFORMANCE TESTED. OUR INVESTIGATION IS THUS BASED ON THE EVALUATION OF THE SUBJECT DEVICE, THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY, AND OUR KNOWLEDGE OF THE PRODUCT. RESULT: THE SUBJECT DEVICE WAS INSPECTED AND PERFORMANCE TESTED. THE DEVICE HAS SUCCESSFULLY PASSED THE PERFORMANCE TESTING AT THE FISHER & PAYKEL HEALTHCARE (F&P). NO DEFECTS WERE FOUND WITH RETURNED DEVICE. CONCLUSION: WE ARE UNABLE TO CONFIRM THE REPORTED EVENT. NO DEFECTS WERE FOUND WITH RETURNED DEVICE.

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: THE RD065 NEOPUFF SPARE MANOMETER KIT IS AN ACCESSORY OF RD900AEU WHICH IS SOLD IN THE UNITED STATES OF AMERICA (USA). THE 510(K) OF THE RD900AEU IS K971695. FISHER & PAYKEL HEALTHCARE (F&P) IS CURRENTLY IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN (B)(6) HAS REPORTED THAT THE RD065 NEOPUFF SPARE MANOMETER KIT HAS FAILED THE PERFORMANCE TESTING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN MICHIGAN HAS REPORTED THAT THE RD065 NEOPUFF SPARE MANOMETER KIT HAS FAILED THE PERFORMANCE TESTING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2232315 FISHER & PAYKEL HEALTHCARE NEOPUFF INFANT RESUSCITATOR FMT FISHER & PAYKEL HEALTHCARE LTD RD065 2103698133 09420012477453

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown