BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1907975 · Received November 24, 2010

    Report

    Report Number
    9611451-2010-00704
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Report Date
    November 2, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MANUFACTURE DATE: 07/29/2009 FOR LOT NUMBER 090729. METHOD: THE TWO MR290V HUMIDIFICATION CHAMBERS THAT WERE RETURNED TO FPH (B)(4) WERE VISUALLY INSPECTED FOR DAMAGE. RESULTS: A CRACK WAS FOUND IN THE DOME OF THE MR290 CHAMBER WITH LOT NUMBER 090515. THE CRACK EXTENDED IN A SLIGHT CURVE FROM THE LEFT SIDE OF THE BAFFLE AND HALFWAY TO THE BASE. NO FAULT WAS FOUND WITH THE CHAMBER WITH LOT NUMBER 090729. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 090515. CONCLUSION: THE MR290V DAMAGE IS CONSISTENT WITH PHYSICAL IMPACT. ALL MR290 CHAMBERS ARE PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. ANY CHAMBER WHICH FAILS EITHER OF THESE TESTS IS REJECTED. THIS SUGGESTS THAT THE CHAMBER WAS DAMAGED POST PRODUCTION, POSSIBLY DURING TRANSPORT OR STORAGE. THE MR290 USER INSTRUCTIONS STATE THE FOLLOWING: "DO NOT USE THE CHAMBER IF THE SEALS ARE NOT INTACT WHEN RECEIVED, OR IF IT HAS BEEN DROPPED." "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) FIELD REPRESENTATIVE THAT TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS LEAKED DURING SET UP. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 090515 AND 090729

    Patients

    Seq Age Sex Outcome Treatment
    1