BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 5777733 · Received July 8, 2016

    Report

    Report Number
    9611451-2016-00328
    Event Type
    Malfunction
    Date Received
    July 8, 2016
    Date of Event
    June 10, 2016
    Report Date
    June 16, 2016
    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

    Narratives

    Additional Manufacturer Narrative · 1

    PS215305, PS215306, PS215307. WHERE: PS215305 - DEVICE 1, LOT 160212, DATE OF MANUFACTURE: 12 FEBRUARY 2016. PS215306 - DEVICE 2, LOT 160212, DATE OF MANUFACTURE: 12 FEBRUARY 2016. PS215307 - DEVICE 3, LOT 160212, DATE OF MANUFACTURE: 12 FEBRUARY 2016. METHOD: THE THREE COMPLAINT MR290 HUMIFICATION CHAMBERS WERE RECEIVED AT FPH IN (B)(4) FOR EVALUATION AND WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A VERTICAL CRACK IN ALL THREE CHAMBER DOMES NEXT TO THE BRACKET. IN DEVICE 3, A SECOND VERTICAL CRACK WAS OBSERVED BELOW ONE OF THE PORTS. A WHITE MARK WAS FOUND AROUND THE DOME PARALLEL TO THE BASE IN THE THREE CHAMBERS. THE DOMES OF ALL THREE CHAMBERS APPEARED TO BE SLIGHTLY BULGING AT THE WHITE MARK. A LOT CHECK REVEALED A TOTAL OF (B)(4) COMPLAINTS TO DATE FOR LOT 160212 (DEVICE 1, 2 AND 3). CONCLUSION: WE WERE UNABLE TO CONCLUSIVELY DETERMINE WHAT HAD CAUSED THE CHAMBER DOMES TO CRACK. EVERY MR290V 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. THE SUBJECT MR290V CHAMBERS WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THE CRACK ON THE CHAMBER DOME OCCURRED AFTER TWO OR THREE DAYS OF USE SUGGESTS THAT IT WAS INITIALLY FUNCTIONING CORRECTLY. THE USER INSTRUCTIONS THAT ACCOMPANY THE MR290V VENTED AUTOFEED HUMIFICATION CHAMBER STATE THE FOLLOWING: "DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS." "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." "SET APPROPRIATE VENTILATOR ALARM." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT."

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY REPORTED VIA A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT THREE MR290 HUMIDIFICATION CHAMBER DOMES WERE CRACKED. THE FIRST DEVICE CRACKED AFTER 7 DAYS OF USE, THE SECOND DEVICE AFTER 3 DAYS OF USE, AND THE THIRD DEVICE AFTER 4 DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432383 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 2100023915

    Patients

    Seq Age Sex Outcome Treatment
    1 TRILOGY O2 PLUS VENTILATOR