BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3091026 · Received May 3, 2013

    Report

    Report Number
    9611451-2013-00354
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 4, 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). DEVICES RETURNED FOR INVESTIGATION: DEVICE 1: MR290V LOT#: 121001; DEVICE 2: MR290V LOT#: 121002; DEVICE 3: MR290V LOT#: 120912. METHOD: THREE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WERE VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION REVEALED A BREAK IN THE WATER FEEDSET TUBE AT THE CONNECTION TO THE CHAMBER DOME ON DEVICES 1 AND 3. DEVICE 2 EXHIBITED A BREAK IN THE WATER FEEDSET TUBE WHERE IT IS INSERTED TO THE BAG SPIKE. THE SURFACE OF THE BREAKS ON ALL THREE WATER FEEDSET TUBES WERE ROUGH (NOT SMOOTHLY CUT). A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 121001 AND THREE OTHER COMPLAINTS FOR LOT NUMBER 120912. NO COMPLAINTS OF THIS NATURE WERE IDENTIFIED FOR LOT 121002. CONCLUSION: THE BREAK ON ALL THREE FEEDSET TUBES WAS ROUGH, SUGGESTING THAT THE DAMAGE MAY HAVE OCCURRED AS A RESULT OF THE TUBES BEING PULLED AWAY FROM THE CHAMBERS 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."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO OUR DISTRIBUTOR THAT THE WATER FEEDSET TUBES ON THREE MR290 AUTOFEED HUMIDIFICATION CHAMBERS WERE DAMAGED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193885 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 120912

    Patients

    Seq Age Sex Outcome Treatment
    1