BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 21782054 · Received April 6, 2025

    Report

    Report Number
    9611451-2025-00299
    Event Type
    Malfunction
    Date Received
    April 6, 2025
    Report Date
    March 7, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). METHOD: THE SUBJECT DEVICE, RD900AEU NEOPUFF INFANT RESUSCITATOR WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P), NEW ZEALAND FOR EVALUATION. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY AND OUR KNOWLEDGE OF THE PRODUCT. RESULT: THE HEALTHCARE FACILITY HAS REPORTED THAT THE GAS OUTLET PORT OF THE SUBJECT DEVICE WAS BROKEN. CONCLUSION: WITHOUT THE RETURN OF THE SUBJECT DEVICE FOR EVALUATION WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED COMPLAINT. 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". 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. EACH NEOPUFF UNIT IS ASSEMBLED AND 100% TESTED IN THE PRODUCTION LINE TO VERIFY THAT EACH UNIT CONFORMS TO CRITICAL PRODUCT SPECIFICATIONS. ANY UNIT THAT FAILS IS REJECTED. THE SUBJECT NEOPUFF WOULD HAVE MET THE REQUIREMENTS AT THE TIME OF PRODUCTION.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN PETERSBURG HAS REPORTED THAT AN RD900AEU NEOPUFF INFANT RESUSCITATOR'S GAS OUTLET PORT WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE DEVICE WILL NOT BE SENT TO FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTER FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942886 FISHER & PAYKEL HEALTHCARE NEOPUFF INFANT RESUSCITATOR FMT FISHER & PAYKEL HEALTHCARE LTD RD900AEU 2102540633

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown