BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 19555465 · Received June 18, 2024

    Report

    Report Number
    9611451-2024-00443
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    May 16, 2024
    Report Date
    May 31, 2024
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K122432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTIONS: SECTION D1: BRAND NAME UPDATED TO FISHER & PAYKEL HEALTHCARE. SECTION D2A: COMMON DEVICE NAME UPDATED TO BREATHING CIRCUIT. SECTION D2B: PRODUCT CODE UPDATED TO BZE. SECTION D4: MODEL AND CATALOG NUMBER UPDATED TO RT232. SECTION D4: LOT NUMBER AND UDI DETAILS WERE NOT RECEIVED. SECTION D4: PMA/510(K) NUMBER UPDATED TO K122432. METHOD: THE SUBJECT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL (F&P) HEALTHCARE IN NEW ZEALAND WHERE IT WAS VISUALLY INSPECTED AND ANALYSED. RESULTS: VISUAL INSPECTION OF THE RETURNED MR290V CHAMBER IDENTIFIED SEVERAL CRACKS AROUND THE BASE OF THE CHAMBER DOME. WHITE RESIDUE WAS OBSERVED AROUND THE CHAMBER BASE AND INSIDE OF THE CHAMBER DOME. ADDITIONAL MATERIAL ANALYSIS OF THE WHITE RESIDUE IDENTIFIED THAT THE CHAMBER WAS MOST LIKELY EXPOSED TO AN INCOMPATIBLE CHEMICAL. CONCLUSION: THE REPORTED LEAK WAS FOUND TO BE DUE TO SEVERAL CRACKS THAT WERE OBSERVED ON THE CHAMBER DOME. THE CRACKS ARE MOST LIKELY DUE TO EXPOSURE TO AN INCOMPATIBLE CHEMICAL. THE MR290V CHAMBERS ARE DESIGNED AND TESTED TO CONFORM TO ISO 5367 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS. EVERY MR290V CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. ANY CHAMBER WHICH FAILS THIS TEST IS REJECTED. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. NO CRACKS IN THE CHAMBER DOME ARE ACCEPTABLE. ANY CHAMBER THAT FAILS THIS INSPECTION IS REJECTED. THE SUBJECT MR290V CHAMBERS WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT232 BREATHING CIRCUIT STATE THE FOLLOWING: "DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS." "SET APPROPRIATE VENTILATOR ALARMS." "FOR SINGLE PATIENT USE ONLY. REUSE MAY RESULT IN TRANSMISSION OF INFECTIOUS SUBSTANCES, INTERRUPTION TO TREATMENT, OR SERIOUS HARM. ATTEMPTING TO REPROCESS WILL RESULT IN DEGRADATION OF MATERIAL AND RENDER THE PRODUCT DEFECTIVE.

    Additional Manufacturer Narrative · 0

    (B)(4). THE SUBJECT DEVICE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER HAS BEEN REQUESTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN FRANCE REPORTED THAT A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER, PROVIDED AS PART OF A RT232 ADULT OPTIFLOW CIRCUIT KIT, WAS FOUND LEAKING WATER DURING PATIENT USE. THERE WAS NO PATIENT HARM REPORTED.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN FRANCE REPORTED THAT A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER, PROVIDED AS PART OF A RT232 ADULT OPTIFLOW CIRCUIT KIT, WAS FOUND LEAKING WATER DURING PATIENT USE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244841 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE LTD RT232
    1687670 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE LTD RT232

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown