BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 19327520 · Received May 15, 2024

    Report

    Report Number
    9611451-2024-00364
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Date of Event
    April 11, 2024
    Report Date
    April 16, 2024
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    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

    (B)(4). FISHER & PAYKEL HEALTHCARE HAS REQUESTED FOR THE RETURN OF THE SUBJECT DEVICE FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTION: SECTION D1: BRAND NAME UPDATED TO FISHER & PAYKEL HEALTHCARE. SECTION G4: PMA/510(K) NUMBER UPDATED TO K934140. H11: METHOD: THE SUBJECT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO F&P HEALTHCARE IN NEW ZEALAND, WHERE IT WAS VISUALLY INSPECTED AND ANALYSED. RESULTS: VISUAL INSPECTION OF THE RETURNED MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER CONFIRMED THE REPORTED CRACK NEAR THE FLANGE. THE HEALTHCARE FACILITY ADDITIONALLY REPORTED THAT THE CHAMBER WAS IN USE FOR 16 DAYS. CONCLUSION: WE ARE NOT ABLE TO DETERMINE THE CAUSE OF THE CRACK. EVERY MR290 CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER 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 USER INSTRUCTIONS THAT ACCOMPANY THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER STATE THE FOLLOWING: "DO NOT USE BEYOND 14 DAYS MAXIMUM DURATION OF USE." "DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS." "ENSURE APPROPRIATE VENTILATOR AND FLOW SOURCE ALARMS ARE SET BEFORE CONNECTING BREATHING SET TO 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."

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER PROVIDED WITH AN RT132 INFANT CONTINUOUS BREATHING CIRCUIT WAS FOUND LEAKING WATER FROM A CRACK IN THE WALL OF THE HUMIDIFICATION CHAMBER. THE HEALTHCARE FACILITY ALSO REPORTED THAT THE SUBJECT CHAMBER HAD BEEN IN USE FOR 16 DAYS. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS FOUND LEAKING WATER FROM A CRACK IN THE WALL OF THE HUMIDIFICATION CHAMBER. THE HEALTHCARE FACILITY ALSO REPORTED THAT THE SUBJECT CHAMBER HAD BEEN IN USE FOR 16 DAYS. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476193 FISHER & PAYKEL HEALTHCARE AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 231017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown F&P HEALTHCARE MR850 RESPIRATORY HUMIDIFIER.| F&P HEALTHCARE RT132 BREATHING CIRCUIT.| MR850 HUMIDIFIER.