BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 22355177 · Received June 30, 2025

    Report

    Report Number
    9611451-2025-00602
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    May 1, 2025
    Report Date
    October 1, 2025
    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)(6). SECTION D4: AFFECTED LOT NUMBERS 240213 - 2 UNITS, 240131 - 1 UNIT, 231211 - 1 UNIT. THE SUBJECT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS HAVE 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.

    Additional Manufacturer Narrative · 0

    (B)(6). SECTION D4: AFFECTED LOT NUMBERS. LOT# 240213 - 2 UNITS. LOT# 240131 - 1 UNIT. LOT# 231211 - 1 UNIT. METHOD: FOUR MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL (F&P) HEALTHCARE IN NEW ZEALAND FOR EVALUATION, WHERE THEY WERE VISUALLY INSPECTED, AND LEAK TESTED. RESULTS: VISUAL INSPECTION IDENTIFIED NO DAMAGE OR DEFECTS WITH THE RETURNED DEVICES. LEAK TESTING CONFIRMED THAT THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE WITHIN SPECIFICATION. CONCLUSION: THE INVESTIGATION FINDINGS CONFIRMED THAT THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICES. ALL MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS ARE VISUALLY INSPECTED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, EVERY MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER IS LEAK TESTED AT THE COMPLETION OF THE ASSEMBLY PROCESS. ANY CHAMBER WHICH FAILS THESE TESTS IS REJECTED. THE SUBJECT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS FOR MR290V HUMIDIFCATION CHAMBER STATE THE FOLLOWING: - CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE. - PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT. - ENSURE APPROPRIATE VENTILATOR OR 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 FOUR MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS FAILED THE VENTILATOR LEAK TEST PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN, THAT FOUR MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS FAILED THE VENTILATOR LEAK TEST PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755520 VENTED HUMIDIFICATION CHAMBER VENTED HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V SEE H11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown