BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 3151023 · Received June 6, 2013

    Report

    Report Number
    9611451-2013-00445
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 8, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE IT WAS VISUALLY EXAMINED FOR THE REPORTED DAMAGE. RESULTS: VISUAL EXAMINIATION REVEALED A CUT IN THE FILTER OF THE WATER BAG SPIKE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 121026. CONCLUSION: WE WERE UNABLE TO DETERMINE THE CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER. ALL MR290 CHAMBERS ARE PRESSURE TESTED AND VISUALLY INSPECTED PRIOR TO BEING RELEASED FOR DISTRIBUTION. ANY CHAMBERS THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE REPORTED LEAK ONLY DEVELOPED AFTER THE CHAMBER WAS RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS THAT ARE SUPPLIED WITH THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER STATE THE FOLLOWING: "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 VIA OUR DISTRIBUTOR THAT WATER WAS LEAKING FROM THE FEEDSET TUBE ON AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251523 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 121026

    Patients

    Seq Age Sex Outcome Treatment
    1