BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 22333759 · Received June 25, 2025

    Report

    Report Number
    9611451-2025-00582
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Report Date
    July 31, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    UDI-DI
    09420012478450
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    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: RD061 IS THE NEOPUFF SPARE FASCIA & VALVE ASSEMBLY OF RD900 NEOPUFF AND THE 510(K) FOR THE NEOPUFF IS K971695.

    Additional Manufacturer Narrative · 0

    (B)(4). METHOD: THE SUBJECT RD061 ALONG WITH THE RD900AEU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) IN NEW ZEALAND FOR EVALUATION. OUR INVESTIGATION IS BASED ON THE ANALYSIS OF THE RETURNED DEVICE, INFORMATION PROVIDED BY THE HEALTHCARE FACILITY, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION OF THE SUBJECT DEVICE HAS REVEALED THAT THE MAX PRESSURE RELIEF COVER WAS STUCK AND COULD NOT BE ROTATED, CONFIRMING THE REPORTED FAULT. THE COVER WAS REMOVED BY MANIPULATING IT SIDE TO SIDE AND A TRACES OF GLUE WAS OBSERVED AROUND THE COVER BY THE CONNECTION POINT WITH THE PORT. CONCLUSION: THE CAUSE OF THE REPORTED MALFUNCTION WAS DUE TO EXCESS GLUE APPLIED TO THE INLET PORT, WHICH DID NOT DRY PROPERLY PRIOR TO ASSEMBLING THE MAX PRESSURE COVER DURING MANUFACTURING. G4: RD061 IS THE NEOPUFF SPARE FASCIA & VALVE ASSEMBLY OF RD900 NEOPUFF AND THE 510(K) FOR THE NEOPUFF IS K971695.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN AUSTRALIA HAS REPORTED THAT THE MAXIMUM PRESSURE RELIEF KNOB COVER/ FLAP OF A NEW RD061 NEOPUFF SPARE FASCIA & VALVE ASSEMBLY WAS GLUED TO THE INLET PORT AND CANNOT MOVE ON A RD900AEU NEOPUFF INFANT RESUSCITATOR. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN AUSTRALIA HAS REPORTED THAT THE MAXIMUM PRESSURE RELIEF KNOB COVER/ FLAP OF A NEW RD061 NEOPUFF SPARE FASCIA & VALVE ASSEMBLY WAS GLUED TO THE INLET PORT AND CANNOT MOVE ON A RD900AEU NEOPUFF INFANT RESUSCITATOR. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530344 FISHER & PAYKEL HEALTHCARE NEOPUFF SPARE FASCIA & VALVE ASSEMBLY FMT FISHER & PAYKEL HEALTHCARE LTD RD061 2103771298 09420012478450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown