BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 3131832 · Received May 29, 2013

    Report

    Report Number
    9611451-2013-00428
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    March 29, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4). IT WAS VISUALLY INSPECTED AND CONNECTED TO A WATERBAG TO TEST FOR THE REPORTED LEAK. RESULTS: UPON CONNECTING THE RETURNED CHAMBER TO A WATER BAG, A SMALL DROP OF WATER BEGAN TO BUILD AT THE CONNECTION BETWEEN THE FEEDSET TUBE AND THE WATERBAG SPIKE. VISUAL INSPECTION REVEALED THAT THE WATER FEEDSET TUBE WAS SLIGHTLY PULLED OUT OF THE SPIKE. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 120522. CONCLUSION: THE LEAK IDENTIFIED ON THE RETURNED WATER FEEDSET TUBE WAS MOST LIKELY CAUSED BY THE TUBE BEING SET UP IN TENSION OR ACCIDENTALLY PULLED USING EXCESSIVE FORCE. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE, AND ANY HOLES OR LEAKS IN THE FEEDSET TUBE ARE IDENTIFIED DURING THIS PROCESS. 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. (B)(4). THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER STATE THE FOLLOWING: "SET APPROPRIATE VENTILATOR ALARM." "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 TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT WATER WAS FEEDING MORE THAN USUAL FROM THE WATER FEEDSET TUBE ON AN MR290 AUTOFEED HUMIDIFICATION CHAMBER. HOWEVER THE WATER LEVEL DID NOT EXCEED THE MAXIMUM WATER LEVEL LINE. UPON RECEIVING THE DEVICE A LEAK WAS IDENTIFIED FROM THE CONNECTION BETWEEN THE WATERFEED SET TUBE AND THE BAG SPIKE. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236875 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 120522

    Patients

    Seq Age Sex Outcome Treatment
    1