BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2060492 · Received April 17, 2011

    Report

    Report Number
    9611451-2011-00249
    Event Type
    Malfunction
    Date Received
    April 17, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 25, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    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). METHOD: THE TWO COMPLAINT CHAMBERS HAVE NOT BEEN RETURNED TO THE MANUFACTURER. IT HAS BEEN PERFORMANCE TESTED BY A FISHER & PAYKEL HEALTHCARE SERVICE ENGINEER AT OUR REGIONAL OFFICE IN (B)(4). BOTH CHAMBERS HAD LOT NUMBER 100213. RESULTS: THE PERFORMANCE TEST CONFIRMED THE WATER LEAKAGE FOR BOTH CHAMBERS AS OBSERVED BY THE CUSTOMER. A LOT CHECK REVEALED SIX OTHER SIMILAR COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. 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 WHICH ACCOMPANY THE MR290 STATE THE FOLLOWING: "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. OUR MONITORING AND TRENDING OF COMPLAINTS INVOLVING DAMAGED MR290 WATER FEEDSETS HAS A RATE OF OCCURRENCE OF 34 DEVICES PER MILLION SOLD WORLDWIDE IN THE LAST YEAR TO THE END OF MARCH 2011.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THERE WAS WATER LEAKAGE FROM THE WATER FEEDSET OF TWO MR290V AUTOFEED HUMIDIFICATION CHAMBERS DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 100213

    Patients

    Seq Age Sex Outcome Treatment
    1