BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3181141 · Received June 21, 2013

    Report

    Report Number
    9611451-2013-00487
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 24, 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: THE COMPLAINT MR290V VENTED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE IT WAS VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION REVEALED A BREAK IN THE FEEDSET TUBE AT THE CONNECTION TO THE CHAMBER DOME. THE SURFACE OF THE BREAK WAS ROUGH (NOT SMOOTHLY CUT). A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 121123. CONCLUSION: THE DAMAGE OBSERVED ON THE RETURNED MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS MOST LIKELY CAUSED BY THE FEEDSET TUBE BEING CAUGHT OR UNDER TENSION. WE HAVE CONDUCTED EXTENSIVE TESTING OF THE MR290 CHAMBER, WITH PARTICULAR EMPHASIS ON FEEDSET BREAKS. SIGNIFICANTLY WE HAVE NOT BEEN ABLE TO REPLICATE FAILURE OF THE FEEDSET TUBE AT THE CHAMBER DOME IN ANY OF OUR TESTING. THE SPECIFICATION FOR THE CHAMBER REQUIRES THAT THE FEEDSET TUBE SHOULD HAVE A BREAKING STRAIN OF 30 NEWTONS. DURING PRODUCTION, PULL TESTING OF THE FEEDSET STRENGTH AT BOTH SPIKE AND DOME END IS PERFORMED EVERY HOUR ON MR290 CHAMBERS FROM EACH PRODUCTION LINE. 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 TO THE FEEDSET TUBE OCCURRED AFTER THE PRODUCT WAS RELEASED FOR DISTRIBUTION. 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." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE WATER FEEDSET TUBE WAS LEAKING ON AN MR290 AUTOFEED HUMIDIFICATION CHAMBER. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281830 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 121123

    Patients

    Seq Age Sex Outcome Treatment
    1 RT200 ADULT DUAL-HEATED BREATHING CIRCUIT