BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 21372103 · Received February 13, 2025

    Report

    Report Number
    9611451-2025-00122
    Event Type
    Malfunction
    Date Received
    February 13, 2025
    Report Date
    January 14, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    UDI-DI
    09420012410931
    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)(4). FISHER AND PAYKEL HEALTHCARE (F&P) ARE 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). METHOD: THE SUBJECT DEVICE, RD900AEU NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO OUR FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTER IN CALIFORNIA AND HAS BEEN FORWARDED TO F&P, NZ FOR EVALUATION. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE F&P SERVICE TECHNICIAN, INFORMATION PROVIDED BY THE HEALTHCARE FACILITY, PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION OF THE SUBJECT DEVICE CONFIRMS THE MANOMETER IS IN GOOD CONDITION AND THE NEEDLE POINTING AT 0CMH2O. THE MANOMETER HAS PASSED THE PERFORMANCE TESTING, AND THE REPORTED FAILURE COULD NOT BE REPLICATED. THE REPORTED FAILURE COULD NOT BE CONFIRMED AT F&P NZ. A REVIEW OF F&P SERVICE TECHNICIAN FINDINGS REVEALS THAT THE MANOMETER NEEDLE WAS NONOPERATIONAL DURING AN INSPECTION AT THE SERVICE CENTER IN (B)(6). CONCLUSION: WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THE REPORTED FAULT. 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 THIRD-PARTY VENDOR ON BEHALF OF A HEALTHCARE FACILITY IN VIRGINIA REPORTED THAT THE RD900AEU NEOPUFF INFANT RESUSCITATOR'S MANOMETER NEEDLE WAS STUCK. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.

    Description of Event or Problem · 0

    A THIRD PARTY VENDOR ON BEHALF OF A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE RD900AEU NEOPUFF INFANT RESUSCITATOR'S MANOMETER NEEDLE WAS STUCK. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100838 FISHER & PAYKEL HEALTHCARE NEOPUFF INFANT RESUSCITATOR FMT FISHER & PAYKEL HEALTHCARE LTD RD900AEU 2101302552 09420012410931

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown