BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2060491 · Received April 17, 2011

    Report

    Report Number
    9611451-2011-00246
    Event Type
    Malfunction
    Date Received
    April 17, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 24, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY ENDEAVOURING TO OBTAIN FURTHER INFORMATION WITH REGARD TO THIS COMPLAINT. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT CHAMBER HAS NOT BEEN RETURNED FOR EVALUATION. OUR ANALYSIS IS ACCORDINGLY BASED ON THE EVENT DESCRIPTION AND OUR KNOWLEDGE OF THE PRODUCT. WITHOUT THE RETURN OF THE COMPLAINT CHAMBER WE ARE UNABLE TO DETERMINE THE ROOT CAUSE. HOWEVER, BASED ON FINDINGS FROM SIMILAR COMPLAINTS, THE FEEDSET TUBE WAS MOST LIKELY LEAKING DUE TO INSUFFICIENT GLUE HAVING BEEN APPLIED BETWEEN THE TUBE AND WATERBAG SPIKE. A LOT CHECK REVEALED SEVEN OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET WOULD BE IDENTIFIED DURING THIS PROCESS. THIS PRODUCT WOULD HAVE FAILED THE FINAL PRESSURE TEST IF IN A BROKEN STATE DURING TESTING. AS PART OF OUR ONGOING PRODUCT IMPROVEMENTS, ADDITIONAL GLUE IS NOW APPLIED TO THE FEEDSET SPIKE DURING PRODUCTION. 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." (B)(4).

    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 THE MR290V AUTOFEED HUMIDIFICATION CHAMBER DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(4) REPORTED VIA OUR DISTRIBUTOR THAT THERE WAS WATER LEAKAGE FROM THE WATER FEEDSET OF THE MR290V AUTOFEED HUMIDIFICATION CHAMBER 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 100216

    Patients

    Seq Age Sex Outcome Treatment
    1