BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT HUMIDIFICATION CHAMBER

    MDR report key: 2256249 · Received September 21, 2011

    Report

    Report Number
    9611451-2011-00593
    Event Type
    Malfunction
    Date Received
    September 21, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 30, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ONE COMPLAINT MR210 HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND VISUALLY INSPECTED FOR CRACKS. RESULTS: THE VISUAL INSPECTION REVEALED THAT THE CHAMBER HAD A SMALL STRESS CRACK ALONG THE BASE OF THE DOME. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT NUMBER 100925. CONCLUSION: BASED ON THE LOCATION OF THE CRACK, IT IS LIKELY THAT STRESS IN THE MOULDED DOME CAUSED THE DOME TO CRACK DURING THE BASE ROLLING PROCESS AND THESE CRACKS WERE NOT NOTICED BY THE OPERATOR DURING THE VISUAL INSPECTION BEFORE PACKING. IT IS LIKELY THAT THE CRACK DEVELOPED IN SIZE DUE TO TRANSPORT AND STORAGE. EVERY MR210 CHAMBER IS 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. AS PART OF OUR ONGOING PRODUCT IMPROVEMENT INITIATIVES, THE NOZZLE OF THE MOULDER HAS BEEN REPLACED TO REDUCE THE STRESS IN THE MOULDED MR210 DOME.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT WATER LEAKED FROM AN MR210 ADULT HUMIDIFICATION CHAMBER DURING USE AND THAT THERE WAS A CRACK AT THE BASE OF THE CHAMBER. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR210 100925

    Patients

    Seq Age Sex Outcome Treatment
    1