BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F&P NEOPUFF

    MDR report key: 24737095 · Received March 30, 2026

    Report

    Report Number
    9611451-2026-01123
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Report Date
    May 7, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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: UDI DETAILS ARE NOT AVAILABLE BASED ON THE TIME OF MANUFACTURING. SECTION G4: THE RD900AZU IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K971695.

    Description of Event or Problem · 0

    A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE MANOMETER OF A RD900AZU NEOPUFF INFANT RESUSCITATOR WAS NOT ZEROING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466767 F&P NEOPUFF NEOPUFF INFANT RESUSCITATOR FMT FISHER & PAYKEL HEALTHCARE LTD RD900AZU 110524

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown