BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 3120986 · Received May 20, 2013

    Report

    Report Number
    9611451-2013-00407
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 23, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290 AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION REVEALED A BREAK IN THE WATER FEEDSET TUBE WHERE IT CONNECTS TO THE CHAMBER DOME. THE SURFACE OF THE BREAK WAS ROUGH. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 120503. CONCLUSION: THE DAMAGE APPEARS TO BE THE RESULT OF THE TUBE BEING PULLED AWAY FROM THE DOME, POSSIBLY DUE TO THE FEEDSET BEING CAUGHT OR UNDER TENSION. THE CUSTOMER HAD REPORTED THAT THE FEEDSET TUBE HAD BECOME SEPARATED FROM THE WATER BAG SPIKE BUT THIS WAS NOT THE CASE WITH THE RETURNED COMPLAINT DEVICE. IT IS POSSIBLE THAT THE CUSTOMER HAD EXPERIENCED ISSUES WITH THE BAG SPIKE DETACHING FROM THE FEEDSET TUBE AS A RESULT OF THE USER PULLING ON THE TUBING TO REMOVE THE BAG SPIKE, RATHER THAN GRASPING THE SPIKE ITSELF. 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 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 THAT THEY WERE HAVING PROBLEMS WITH THE CONNECTION OF THE BAG SPIKE AND THE WATER FEEDSET ON THE MR290V HUMIDIFICATION CHAMBERS. THEY STATED THAT THE BAG SPIKE WAS REMAINING IN THE WATER BAG FOLLOWING REMOVAL OF THE WATER FEEDSET. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222240 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 120503

    Patients

    Seq Age Sex Outcome Treatment
    1