BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT HUMIDIFICATION CHAMBER

    MDR report key: 3120870 · Received May 20, 2013

    Report

    Report Number
    9611451-2013-00404
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 24, 2013
    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: THE COMPLAINT CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND VISUALLY INSPECTED. RESULTS: THE VISUAL INSPECTION REVEALED A CRACK ON THE TOP OF THE CHAMBER DOME NEAR ONE OF THE PORTS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 120717. CONCLUSION: THE CRACK OBSERVED ON THE CHAMBER DOME APPEARS TO HAVE BEEN CAUSED BY PHYSICAL DAMAGE, MOST LIKELY DUE TO SOME FORM OF SIGNIFICANT IMPACT. 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. THIS SUGGESTS THE DAMAGE OCCURRED AFTER RELEASE FOR DISTRIBUTION, EITHER DURING TRANSPORT TO, HANDLING OR STORAGE AT, THE CUSTOMER'S FACILITY.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THERE WAS A CRACK ON ONE OF THE PORTS OF AN MR210 ADULT HUMIDIFICATION CHAMBER. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222043 ADULT HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR210 120717

    Patients

    Seq Age Sex Outcome Treatment
    1