BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2060473 · Received April 17, 2011

    Report

    Report Number
    9611451-2011-00244
    Event Type
    Malfunction
    Date Received
    April 17, 2011
    Report Date
    March 21, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 FEEDET TUBE WAS MOST LIKELY LEAKING DUE TO INSUFFICIENT GLUE HAVING BEEN APPLIED BETWEEN THE TUBE AND WATERBAG SPIKE. A LOT CHECK REVEALED (B)(4) 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, (B)(4). 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 THAT THERE WAS WATER LEAKAGE FROM THE WATER FEED SET OF AN MR290 VENTED AUTOFEED CHAMBER. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THERE WAS WATER LEAKAGE FROM THE WATER FEED SET OF AN MR290 VENTED AUTOFEED CHAMBER. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290VX 100213

    Patients

    Seq Age Sex Outcome Treatment
    1