BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3048384 · Received April 10, 2013

    Report

    Report Number
    9611451-2013-00255
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 11, 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). LOT NUMBERS OF RETURNED MR290 AUTOFEED HUMIDIFICATION CHAMBERS: DEVICE 1: LOT 110912, DEVICE 2: LOT 120109, DEVICE 3: LOT 120502, DEVICE 4: LOT 120110. METHOD: FOUR MR290 AUTOFEED HUMIDIFICATION CHAMBERS WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A BREAK IN THE WATER FEEDSET TUBES AT THE CONNECTION TO THE CHAMBER DOME ON ALL FOUR MR290 AUTOFEED HUMIDIFICATION CHAMBERS. THE SURFACE OF THE BREAK WAS ROUGH (NOT SMOOTHLY CUT). A LOT CHECK REVEALED TWO OTHER COMPLAINTS OF THIS NATURE ONE FROM LOT 120109 AND ONE FROM LOT 120502. CONCLUSION: THE FEEDSET TUBE BREAK WAS ROUGH ON ALL FOUR MR290 AUTOFEED HUMIDIFICATION CHAMBERS, 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." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO OUR DISTRIBUTOR THAT THE HEATER WIRE ADAPTOR WAS FAULTY ON AN RT200 ADULT BREATHING CIRCUIT. UPON INSPECTING THE RETURNED COMPLAINT DEVICES THE WATER FEEDSET TUBES OF THE MR290 AUTOFEED HUMIDIFICATION CHAMBERS INCLUDED IN THE RT200 BREATHING CIRCUIT KIT WERE FOUND TO BE DAMAGED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149647 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 110912

    Patients

    Seq Age Sex Outcome Treatment
    1 RT200 ADULT BREATHING CIRCUIT