BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2662490 · Received July 19, 2012

    Report

    Report Number
    9611451-2012-00483
    Event Type
    Malfunction
    Date Received
    July 19, 2012
    Date of Event
    June 28, 2012
    Report Date
    June 28, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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). METHOD: THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FPH IN (B)(4) FOR EVALUATION. IT WAS VISUALLY INSPECTED FOR LEAKS AND WAS CONNECTED TO A WATERBAG FOR FUNCTIONAL TESTING. RESULTS: THE CHAMBER FILLED NORMALLY WHEN CONNECTED TO A WATERBAG; HOWEVER, ONCE THE CHAMBER HAD FILLED, SMALL DROPS OF WATER WERE OBSERVED TO LEAK FROM THE CONNECTION BETWEEN THE FEEDSET TUBE AND WATERBAG SPIKE. INSPECTION SHOWED THAT INSUFFICIENT GLUE HAD BEEN APPLIED BETWEEN THE CONNECTION OF THE FEEDSET TUBE AND SPIKE, CAUSING THE LEAK. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 100326. CONCLUSION: ALL CHAMBERS ARE PRESSURE TESTED BEFORE LEAVING THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290 STATE THE FOLLOWING: -"SET APPROPRIATE VENTILATOR ALARMS." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." THE WATERFEED TUBING IS ATTACHED TO THE SPIKE BY AN AUTOMATED GLUING PROCESS. AS PART OF OUR ONGOING IMPROVEMENT PROCESS, ADDITIONAL GLUE IS NOW APPLIED TO THE WATER FEEDSET SPIKE DURING THE AUTOMATED ASSEMBLY. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT WATER LEAKED OCCURRED AT THE CONNECTION BETWEEN THE WATER FEEDSET TUBE AND SPIKE OF AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER AFTER 8 DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 100326

    Patients

    Seq Age Sex Outcome Treatment
    1