BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPUFF INFANT RESUSCITATOR

    MDR report key: 20061207 · Received August 25, 2024

    Report

    Report Number
    9611451-2024-00616
    Event Type
    Malfunction
    Date Received
    August 25, 2024
    Report Date
    August 5, 2024
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: THE (B)(4) IS NOT MARKETED IN THE UNITED STATES. HOWEVER, A SIMILAR DEVICE HAS BEEN CLEARED UNDER 510(K) K892885. METHOD: THE COMPLAINT (B)(4) NEOPUFF INFANT RESUSCITATOR WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTER IN FRANCE WHERE IT WAS VISUALLY INSPECTED AND PERFORMANCE TESTED BY A TRAINED F&P TECHNICIAN. RESULTS: VISUAL INSPECTION AND THE PERFORMANCE TESTING OF THE COMPLAINT (B)(4) NEOPUFF INFANT RESUSCITATOR REVEALED THAT THE MANOMETER WAS OUT OF SPECIFICATION. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. THE MOST LIKELY CAUSE COULD BE DUE TO MANOMETER BEING SUBJECTED TO AN IMPACT. IF MANOMETER BEING SUBJECTED TO AN IMPACT, IT CAN DISRUPT ITS DELICATE INTERNAL SETUP, POTENTIALLY LEADING TO MISALIGNMENT OF CRITICAL COMPONENTS LIKE CALIBRATED SCREWS. THE NEOPUFF IS A PORTABLE, REUSABLE DEVICE USED TO ASSIST IN THE DELIVERY OF RESPIRATORY BREATHS TO INFANTS UNTIL ADEQUATE SPONTANEOUS BREATHING OCCURS. BEING 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 STATES THE FOLLOWING: - DROPPING THE NEOPUFF 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. 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 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 REQUIRED SPECIFICATION AT TIME OF PRODUCTION.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN FRANCE REQUESTED FOR DEVICE SERVICE VIA A FISHER AND PAYKEL (F&P) HEALTHCARE REPRESENTATIVE ON AN RD900 NEOPUFF INFANT RESUSCITATOR. DURING DEVICE SERVICE IT WAS FOUND OUT THAT THE MANOMETER WAS OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480656 NEOPUFF INFANT RESUSCITATOR BTL BTL FISHER & PAYKEL HEALTHCARE LTD RD900AFU 050715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown