BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 16403106 · Received February 20, 2023

    Report

    Report Number
    9611451-2023-00051
    Event Type
    Malfunction
    Date Received
    February 20, 2023
    Date of Event
    January 15, 2023
    Report Date
    January 23, 2023
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    UDI-DI
    09420012429728
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PS414786 CORRECTED DATA: SECTION D1. BRAND NAME: VENTED AUTOFEED HUMIDIFICATION CHAMBER SECTION D2. COMMON DEVICE NAME: AUTOFEED CHAMBER DEVICE PRODUCT CODE: BTT SECTION D4. MODEL NUMBER: MR290V CATALOG NUMBER: MR290V SECTION D10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: F&P RT380 ADULT EVAQUA2 BREATHING CIRCUIT SECTION G4. PMA/510(K): K934140 METHOD: THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) IN NEW ZEALAND WHERE IT WAS VISUALLY INSPECTED AND ANALYSED. RESULTS: VISUAL INSPECTION OF THE RETURNED MR290V CHAMBER REVEALED ONE VERTICAL CRACK PROPAGATING FROM THE INLET PORT. THE ROLLED BASE THICKNESS WAS MEASURED ON 4 SIDES OF THE CHAMBER AND WAS FOUND TO BE WITHIN SPECIFICATION. CONCLUSION: WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE CHAMBER CRACK. OUR INVESTIGATION INDICATES THAT THE CRACK WAS DUE TO MECHANICAL STRESS. THE STRESS SOURCE WAS UNABLE TO BE IDENTIFIED. THE MR290 CHAMBERS ARE DESIGNED AND TESTED TO CONFORM TO ISO 5367 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS. EVERY MR290 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 CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER STATE THE FOLLOWING: - "DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS." - "ENSURE APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS ARE SET BEFORE CONNECTING BREATHING SET TO PATIENT." - "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." - "USE OF THE MR290 ABOVE THE MAXIMUM OPERATING PRESSURE MAY LEAD TO CRACKING, WATER LEAKAGE AND, ON RARE OCCASIONS, COULD LEAD TO A LOSS OF VENTILATION PRESSURE." - "ENSURE THERE IS WATER SUPPLY CONNECTED TO THE CHAMBER AND THAT WATER IS PRESENT WITHIN THE CHAMBER." - "DO NOT USE THE CHAMBER IF THE SEALS ARE NOT INTACT WHEN RECEIVED, OR IF IT HAS BEEN DROPPED."

    Additional Manufacturer Narrative · 0

    (B)(4). THE COMPLAINT RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE. WE WILL SEND A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    A DISTRIBUTOR ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE PRE-USE LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A DISTRIBUTOR ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE PRE-USE LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228620 VENTED AUTOFEED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 2102234418 09420012429728
    2094489 VENTED AUTOFEED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 2102234418 09420012429728

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown F&P RT380 ADULT EVAQUA2 BREATHING CIRCUIT