BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 19150072 · Received April 21, 2024

    Report

    Report Number
    9611451-2024-00295
    Event Type
    Malfunction
    Date Received
    April 21, 2024
    Date of Event
    March 18, 2024
    Report Date
    March 25, 2024
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K122432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 RT380. SECTION D4: LOT NUMBER AND UDI DETAILS WERE NOT RECEIVED. SECTION D4: PMA/510(K) NUMBER UPDATED TO K122432. SECTION G1: CONTACT PERSON UPDATED TO MR. (B)(6). 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 A CRACK NEAR THE FLANGE OF THE CHAMBER DOME. ADDITIONALLY, STRESS WHITENING WAS OBSERVED ON THE DOME. CONCLUSION: THE STRESS WHITENING INDICATES THAT THE DOME WAS SUBJECTED TO SIGNIFICANT EXTERNAL MECHANICAL FORCE. WE ARE UNABLE TO CONFIRM THE CAUSE OF THE EXTERNAL MECHANICAL FORCE. 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 RT380 BREATHING CIRCUIT 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."

    Additional Manufacturer Narrative · 0

    (B)(4). 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 A CRACK ON THE FLANGE OF THE CHAMBER DOME. ADDITIONALLY, STRESS WHITENING WAS OBSERVED ON THE DOME. CONCLUSION: THE STRESS WHITENING INDICATES THAT THE DOME WAS SUBJECTED TO SIGNIFICANT EXTERNAL MECHANICAL FORCE. WE ARE UNABLE TO CONFIRM THE CAUSE OF THE EXTERNAL MECHANICAL FORCE. THE MR290 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 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."

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN JAPAN REPORTED THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND LEAKING WATER DURING PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN JAPAN REPORTED THAT A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH A RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT KIT WAS FOUND LEAKING WATER DURING PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN JAPAN REPORTED THAT A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH A RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT KIT WAS FOUND LEAKING DURING PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111115 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE LTD RT380 NOT PROVIDED
    1117708 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE LTD RT380 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown F&P HEALTHCARE MR850 RESPIRATORY HUMIDIFIER| F&P HEALTHCARE MR850 RESPIRATORY HUMIDIFIER| F&P HEALTHCARE MR850 RESPIRATORY HUMIDIFIER