BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3098074 · Received May 7, 2013

    Report

    Report Number
    9611451-2013-00361
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 8, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: TWO MR290V AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE THEY WERE VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION REVEALED A BREAK IN THE WATER FEEDSET TUBES AT THE CONNECTION TO THE CHAMBER DOME ON BOTH OF THE RETURNED MR290V VENTED HUMIDIFICATION CHAMBERS. THE SURFACE OF THE BREAKS WAS ROUGH (NOT SMOOTHLY CUT). A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120524. CONCLUSION: THE BREAK IN THE FEEDSET TUBES ON BOTH OF THE MR290V VENTED HUMIDIFICATION CHAMBERS WAS ROUGH, SUGGESTING THAT THE DAMAGE MAY HAVE OCCURRED AS A RESULT OF THE TUBE BEING PULLED AWAY FROM THE CHAMBER POSSIBLY DUE TO THE FEEDSET BEING CAUGHT OR UNDER TENSION. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. THIS SUGGESTS THAT THE DAMAGE OCCURRED POST PRODUCTION. THE 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."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) RETURNED TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS VIA OUR DISTRIBUTOR. UPON INSPECTING THE RETURNED DEVICES IT WAS REVEALED THAT THE FEEDSET TUBES WERE DAMAGED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199790 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 120524

    Patients

    Seq Age Sex Outcome Treatment
    1