BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 22948858 · Received September 2, 2025

    Report

    Report Number
    9611451-2025-00829
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Report Date
    September 3, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). SECTION D4: UDI DETAILS ARE NOT AVAILABLE BASED ON THE TIME OF MANUFACTURING. SECTION G4: THE RD900AGU NEOPUFF INFANT RESUSCITATOR IS NOT SOLD IN THE UNITED STATES OF AMERICA (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, RD900AGU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO OUR FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTRE IN GERMANY EVALUATION WHERE IT WAS INSPECTED BY A TRAINED F&P SERVICE TECHNICIAN. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE F&P SERVICE TECHNICIAN, AND OUR KNOWLEDGE OF THE PRODUCT. THE SERVICE CENTRE ALSO REPORTED THAT THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER. RESULTS: PERFORMANCE TESTING OF THE SUBJECT DEVICE CONFIRMED THAT THE PRESSURE DOESN'T REACH THE SET VALUE. CONCLUSION: BASED ON THE INVESTIGATION, THE EVENT IS LIKELY DUE TO A FAULTY VALVE. THE NEOPUFF IS A PORTABLE, REUSABLE DEVICE USED TO ASSIST IN THE DELIVERY OF RESPIRATORY BREATHS TO INFANTS UNTIL ADEQUATE SPONTANEOUS BREATHING OCCURS. BEING A PORTABLE DEVICE, 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". EACH NEOPUFF UNIT UNDERGOES 100% TESTING ON THE PRODUCTION LINE TO ENSURE COMPLIANCE WITH CRITICAL PRODUCT SPECIFICATIONS. UNITS THAT DO NOT MEET THE SPECIFICATIONS ARE REJECTED. THE SUBJECT NEOPUFF WOULD HAVE MET THE REQUIREMENTS AT THE TIME OF PRODUCTION. 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

    DURING DEVICE EVALUATION AND PERFORMANCE TESTING OF A RD900AGU NEOPUFF INFANT RESUSCITATOR AT OUR FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTRE IN GERMANY, IT WAS FOUND THAT THE DEVICE DOESN'T REACH THE REQUIRED PRESSURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2254880 FISHER & PAYKEL HEALTHCARE INFANT RESUSCITATOR FMT FISHER & PAYKEL HEALTHCARE LTD RD900AGU 080129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown