BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 5030604 · Received August 25, 2015

    Report

    Report Number
    9611451-2015-00376
    Event Type
    Malfunction
    Date Received
    August 25, 2015
    Date of Event
    July 24, 2015
    Report Date
    July 27, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER : 090916, MANUFACTURING DATE: 09/16/2009, QUANTITY AFFECTED: (B)(4). LOT NUMBER : 110926, MANUFACTURING DATE: 09/26/2011, QUANTITY AFFECTED: (B)(4). THE COMPLAINT (B)(4) VENTED AUTOFEED HUMIDIFICATION CHAMBERS HAVE ONLY RECENTLY BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE AND ARE CURRENTLY BEING INVESTIGATED. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MANUFACTURE DATE: LOT NUMBER: 090916 MANUFACTURING DATE: 09/16/2009 QUANTITY AFFECTED: 1; 110926 , 09/26/2011, 1. METHOD: TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FPH IN NEW ZEALAND FOR INSPECTION. THE RETURNED CHAMBERS WERE VISUALLY INSPECTED AND PERFORMANCE TESTED FOR OVERFILLING BY CONNECTING TO A WATER BAG, ALLOWING THE WATER TO FLOW INTO THE CHAMBERS. THE CHAMBERS WERE ALSO CUT OPEN TO VERIFY THE DIMENSIONS OF THE COMPONENTS INSIDE. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED TO THE RETURNED CHAMBERS. THERE WAS NO ASSEMBLY ERROR, OBSTRUCTIONS OR LOOSE PARTS INSIDE THE CHAMBERS. WHEN CONNECTED TO A WATER BAG, THE WATER WAS OBSERVED TO RISE ABOVE THE MAXIMUM FILL LINE FOR BOTH CHAMBERS. THE WATER CONTINUED TO RISE UNTIL THE CHAMBERS OVERFILLED. WHEN THE CHAMBERS WERE CUT OPEN, A NUMBER OF COMPONENTS' DIMENSIONS WERE OBSERVED TO BE OUTSIDE OF THE SPECIFICATIONS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR BOTH LOT NUMBERS. CONCLUSION: OVERFILLING IS USUALLY CAUSED BY BOTH THE PRIMARY AND SECONDARY FLOAT MECHANISMS IN THE MR290 HUMIDIFICATION CHAMBER BEING DISABLED. IN CIRCUMSTANCES WHERE THE PRIMARY FLOAT IS DISABLED, THE WATER MAY OVERFILL ABOVE THE BLACK WATER LEVEL LINE OF THE CHAMBER BUT THE SECONDARY FLOAT WILL SERVE AS A BACKUP TO PREVENT THE WATER FROM OVERFLOWING OUTSIDE THE CHAMBER PORT AND ENTERING INTO THE BREATHING CIRCUIT. PERFORMANCE TEST CONFIRMED THAT THE PRIMARY AND SECONDARY FLOAT MECHANISMS IN THE RETURNED MR290 CHAMBERS WERE DISABLED, CAUSING THE WATER TO OVERFILL. THE USER INSTRUCTIONS THAT ACCOMPANY THE MR290 HUMIDIFICATION CHAMBER SPECIFY IN THE WARNING SECTION "DO NOT USE THE CHAMBER IF THE WATER RISES ABOVE THE MAXIMUM WATER LEVEL LINE" ALONG WITH A DIAGRAM DIRECTING THE USER TO CHECK THE WATER LEVEL ON THE CHAMBER. A WRITTEN DESCRIPTION OF THE MEANING OF THE SYMBOLS USED IS ALSO INCLUDED IN THE USER INSTRUCTIONS. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS OVERFILLED DURING SET UP.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS OVERFILLED DURING SET UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560071 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1