BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 23738772 · Received December 8, 2025

    Report

    Report Number
    9611451-2025-01878
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Report Date
    February 4, 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). 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 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.

    Additional Manufacturer Narrative · 0

    (B)(4). 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. METHOD: THE SUBJECT DEVICE, RD900AZU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO OUR FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTER IN CHINA WHERE IT WAS INSPECTED BY A TRAINED F&P SERVICE TECHNICIAN. OUR INVESTIGATION IS THUS BASED ON THE INFORMATION PROVIDED BY THE F&P SERVICE TECHNICIAN, THE INFORMATION AND PHOTOGRAPHY PROVIDED BY THE DISTRIBUTOR, AND OUR KNOWLEDGE OF THE PRODUCT. THE SERVICE CENTRE ALSO REPORTED THAT THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER. RESULT: UPON EVALUATION OF THE PHOTOGRAPHY PROVIDED AND REVIEW OF SERVICE REPORT, IT WAS OBSERVED THAT THE GAS OUTLET PORT OF THE SUBJECT DEVICE WAS BROKEN. CONCLUSION: WE COULD NOT DETERMINE THE CAUSE OF THE REPORTED EVENT. THE NEOPUFF CAN BE SUSCEPTIBLE TO IMPACT DAMAGE, FOR INSTANCE WHEN ACCIDENTALLY DROPPED OR SUBJECTED TO CONSIDERABLE EXTERNAL FORCE. THE NEOPUFF TECHNICAL MANUAL WARNS AGAINST DROPPING THE NEOPUFF OR SUBJECTING IT TO IMPACT DAMAGE WHICH MAY CAUSE THE UNIT TO OPERATE INCORRECTLY. IF THE NEOPUFF IS SUSPECTED TO HAVE BEEN DAMAGED, THE MANOMETER AND VALVE SYSTEM SHOULD BE PERFORMANCE TESTED. IN ADDITION, THE NEOPUFF USER INSTRUCTIONS STATE THAT THE USER SHOULD "CHECK MANOMETER READS ZERO WITH NO GAS FLOW" AND CHECK THE PRESSURE SETTINGS "PRIOR TO EVERY USE OF THE NEOPUFF". AS MENTIONED, THE NEOPUFF TECHNICAL MANUAL STATES THE FOLLOWING: - DROPPING THE NEOPUFF / PERIVENT INFANT RESUSCITATOR OR OTHER SIMILAR FORMS OF IMPACT MAY CAUSE DAMAGE RESULTING IN INCORRECT OPERATION OF THE UNIT. IF YOU SUSPECT DAMAGE TO HAVE OCCURRED, PLEASE PERFORM CHECKS AS OUTLINED [IN THE MANUAL] BEFORE CONNECTION TO A PATIENT.

    Description of Event or Problem · 0

    A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE GAS OUTLET PORT OF AN RD900AZU NEOPUFF INFANT RESUSCITATOR WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE GAS OUTLET PORT OF AN RD900AZU NEOPUFF INFANT RESUSCITATOR WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2422235 FISHER & PAYKEL HEALTHCARE INFANT RESUSCITATOR FMT FISHER & PAYKEL HEALTHCARE LTD RD900AZU 150422

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown