BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 21715731 · Received March 27, 2025

    Report

    Report Number
    9611451-2025-00241
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Report Date
    February 27, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) D4, G4: 900PT562 IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO 900PT563 WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K211560. D4, H4: FISHER & PAYKEL HEALTHCARE (F&P) REQUESTED FOR COMPLETE DEVICE IDENTIFICATION INFORMATION, HOWEVER, THIS HAS NOT BEEN PROVIDED AND THE DEVICE HAS BEEN DISCARDED BY THE HEALTHCARE FACILITY. PRODUCT BACKGROUND: THE AUTOFILL CHAMBER AS PART OF 900PT562 AIRVO TUBE AND CHAMBER KIT WITH NEBULISER ADAPTOR IS A COMPONENT DESIGNED FOR USE WITH THE AIRVO 2 HUMIDIFICATION SERIES TO PROVIDE NASAL HIGH FLOW (NHF) THERAPY. AIR AND OXYGEN ARE BLOWN FROM THE AIRVO 2 INTO THE HUMIDIFICATION CHAMBER WITHIN WHICH WATER IS HEATED BY A HEATER PLATE. THE GASES BECOME HUMIDIFIED IN THE CHAMBER AND THEN PASS INTO A HEATED BREATHING TUBE, THEN TO THE PATIENT INTERFACE. NHF THERAPY IS INTENDED FOR USE WITH SPONTANEOUSLY BREATHING PATIENTS WHO WOULD BENEFIT FROM RECEIVING HIGH FLOW WARMED AND HUMIDIFIED RESPIRATORY GASES NHF THERAPY SHOULD NOT BE USED FOR LIFE SUPPORT PURPOSES, AND APPROPRIATE PATIENT MONITORING MUST BE USED AT ALL TIMES. METHOD: THE COMPLAINT AUTOFILL CHAMBER WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. THE HEALTHCARE FACILITY REPORTED THAT THE SUBJECT DEVICE WAS DISCARDED. F&P'S INVESTIGATION IS BASED ON THE INFORMATION AND PHOTOGRAPH PROVIDED BY THE CUSTOMER, PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, AND F&P'S KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION OF THE PHOTOGRAPH PROVIDED BY THE HEALTHCARE FACILITY REVEALED A CRACK ON THE CHAMBER DOME NEAR THE BASE. THE HEALTHCARE FACILITY STATED THAT THERE WERE NO PATIENT CONSEQUENCES. CONCLUSION: WITHOUT THE RETURN OF THE SUBJECT DEVICE, F&P IS UNABLE TO CONFIRM THE CAUSE OF THE REPORTED EVENT. EVERY AUTOFILL CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER. ANY CHAMBER THAT FAILS THIS TEST IS REJECTED. THE SUBJECT CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. F&P'S USER INSTRUCTIONS THAT ACCOMPANY THE 900PT562 AIRVO TUBE AND CHAMBER KIT WITH NEBULISER ADAPTOR STATE THE FOLLOWING: "DO NOT USE THE AUTOFILL CHAMBER IF IT HAS BEEN DROPPED OR BEEN ALLOWED TO RUN DRY AS THIS COULD LEAD TO THE CHAMBER OVER-FILLING." "DO NOT USE THE AUTOFILL CHAMBER IF THE WATER LEVEL RISES ABOVE THE MAXIMUM WATER LEVEL LINE AS THIS MAY LEAD TO WATER ENTERING THE PATIENT'S AIRWAY." "FOR SINGLE PATIENT USE ONLY. REUSE MAY RESULT IN TRANSMISSION OF INFECTIOUS SUBSTANCES. ATTEMPTING TO REPROCESS WILL RESULT IN DEGRADATION OF MATERIALS AND RENDER THE PRODUCT DEFECTIVE." "AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS."

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE AUTOFILL CHAMBER AS PART OF THE 900PT562 AIRVO TUBE AND CHAMBER KIT WITH NEBULISER ADAPTOR WAS FOUND LEAKING WATER FROM THE CHAMBER BASE DURING USE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438054 FISHER & PAYKEL HEALTHCARE AUTOFILL CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD 900PT562 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown F&P PT3XX AIRVO 3 HUMIDIFER