BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 3112977 · Received May 15, 2013

    Report

    Report Number
    9611451-2013-00385
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR290 AUTOFEED HUMIDIFICATION CHAMBER IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR290 AUTOFEED HUMIDIFICATION CHAMBER 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 120712. 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. WE HAVE CONDUCTED EXTENSIVE TESTING OF OUR 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. (B)(4). ADDITIONALLY ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. CHAMBERS THAT FAIL ANY OF THESE TESTS ARE DISCARDED. 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 AN MR290V HUMIDIFICATION CHAMBER HAD A DAMAGED WATER FEEDSET TUBE AND CHAMBER. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN MR290V HUMIDIFICATION CHAMBER HAD A DAMAGED WATER FEEDSET TUBE AND CHAMBER. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215800 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 120712

    Patients

    Seq Age Sex Outcome Treatment
    1