BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2327236 · Received November 7, 2011

    Report

    Report Number
    9611451-2011-00685
    Event Type
    Malfunction
    Date Received
    November 7, 2011
    Date of Event
    October 8, 2011
    Report Date
    October 14, 2011
    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

    (B)(4). DEVICE MANUFACTURER DATE: LOT 110126 - 01/26/2011; LOT 110321 - 03/21/2011. METHOD: THE TWO RETURNED COMPLAINT CHAMBERS, LOT 110126 AND LOT 110321, WERE CONNECTED TO A WATERBAG FOR FUNCTIONAL TESTING. RESULTS: WHEN THE TWO COMPLAINT CHAMBERS WERE CONNECTED TO A WATERBAG, DROPS OF WATER WERE OBSERVED TO LEAK FROM THE CONNECTION BETWEEN THE FEEDSET TUBE AND WATERBAG SPIKE OF BOTH CHAMBERS. A LOT CHECK REVEALED ONE OTHER SIMILAR COMPLAINT FOR LOT NUMBER 110126. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110321. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED FAULT. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. THIS SUGGESTS THAT THE LEAK DEVELOPED POST PRODUCTION, POSSIBLY AS A RESULT OF FAILURE OF THE GLUE BOND THAT JOINS THE SPIKE OF THE WATER FEEDSET TUBE. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER STATE "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT". OUR TRENDING AND MONITORING OF MR290 FEEDSET LEAKS HAS A RATE OF OCCURRENCE OF 53 DEVICES PER MILLION SOLD IN THE LAST YEAR TO THE END OF SEPTEMBER 2011.

    Description of Event or Problem · 1

    A HOSPITAL IN JAPAN REPORTED THAT WATER LEAKED FROM THE CONNECTION BETWEEN THE WATER FEEDSET TUBE AND BAG SPIKE OF TWO MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBERS AFTER TWO DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 110126, 110321

    Patients

    Seq Age Sex Outcome Treatment
    1