BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1941642 · Received December 29, 2010

    Report

    Report Number
    9611451-2010-00801
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 24, 2010
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE WATER FEEDSET OF THE RETURNED MR290V CHAMBER WAS VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: THE REPORTED FAULT WAS CONFIRMED. A VISUAL INSPECTION REVEALED THAT INSUFFICIENT GLUE HAD BEEN APPLIED BETWEEN THE CONNECTION OF THE FEEDSET SPIKE AND TUBE, CAUSING IT TO LEAK. A LOT CHECK REVEALED 4 OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100220. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT CHAMBERS ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE ((B)(4)) FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE COMPLAINT CHAMBERS AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT WATER LEAKED FROM BETWEEN THE WATER BAG SPIKE AND THE FEEDSET TUBING ON TWO MR290 AUTOFILL HUMIDIFICATION CHAMBERS. NO PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT WATER LEAKED FROM BETWEEN THE WATER BAG SPIKE AND THE FEEDSET TUBING ON TWO MR290 AUTOFILL HUMIDIFICATION CHAMBERS. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 100220

    Patients

    Seq Age Sex Outcome Treatment
    1