BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 24049916 · Received January 12, 2026

    Report

    Report Number
    9611451-2026-00153
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Report Date
    March 3, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

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

    Additional Manufacturer Narrative · 0

    (B)(4). METHOD: THE SUBJECT RD062 IS THE NEOPUFF SPARE FASCIA & VALVE ASSEMBLY WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, INCLUDING A PHOTOGRAPH, AND OUR KNOWLEDGE OF OUR PRODUCT. RESULTS: VISUAL INSPECTION OF THE PROVIDED PHOTOGRAPHY HAS REVEALED THAT THE MANIFOLD PORT ON THE MANOMETER TUBE SIDE WAS BROKEN. CONCLUSION: WE ARE UNABLE TO CONFIRM THE CAUSE OF THE REPORTED EVENT. G4: RD062 IS THE NEOPUFF SPARE FASCIA & VALVE ASSEMBLY FOR RD900 NEOPUFF AND THE 510(K) FOR THE NEOPUFF IS K971695. SECTION D4: DEVICE DETAILS WERE NOT RECEIVED FROM CUSTOMER. SECTION H4: DEVICE MANUFACTURER DATE DETAILS WERE NOT RECEIVED FROM CUSTOMER.

    Description of Event or Problem · 0

    A DISTRIBUTOR IN UNITED STATES HAS REPORTED THAT THE INTERNAL HOSE OF A RD062 NEOPUFF SPARE FASCIA & VALVE ASSEMBLY BROKE OFF DURING INSTALLATION ON A NEOPUFF INFANT RESUSCITATOR. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A DISTRIBUTOR IN UNITED STATES HAS REPORTED THAT THE INTERNAL HOSE OF A RD062 NEOPUFF SPARE FASCIA & VALVE ASSEMBLY BROKE OFF DURING INSTALLATION ON A NEOPUFF INFANT RESUSCITATOR. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106711 FISHER & PAYKEL HEALTHCARE NEOPUFF SPARE FASCIA & VALVE ASSEMBLY FMT FISHER & PAYKEL HEALTHCARE LTD RD062

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown