BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F&P NEOPUFF

    MDR report key: 25212180 · Received May 19, 2026

    Report

    Report Number
    9611451-2026-01711
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Report Date
    May 19, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). 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. SECTION D4: DEVICE DETAILS WERE NOT RECEIVED FROM CUSTOMER. SECTION G4: RD062 IS THE NEOPUFF SPARE FASCIA & VALVE ASSEMBLY FOR RD900 NEOPUFF AND THE 510(K) FOR THE NEOPUFF IS K971695. SECTION H4: DEVICE MANUFACTURER DATE DETAILS WERE NOT RECEIVED FROM CUSTOMER.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN MICHIGAN HAS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THERE WAS NO CHANGE IN PRESSURE WHEN THE KNOBS WERE TURNED ON A RD062 NEOPUFF SPARE FASCIA & VALVE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48950 F&P NEOPUFF NEOPUFF SPARE FASCIA & VALVE ASSEMBLY FMT FISHER & PAYKEL HEALTHCARE LTD RD062

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown