BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT HUMIDIFICATION CHAMBER

    MDR report key: 2120918 · Received June 12, 2011

    Report

    Report Number
    9611451-2011-00351
    Event Type
    Malfunction
    Date Received
    June 12, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 16, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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 RETURNED MR210 CHAMBER WAS VISUALLY INSPECTED FOR CRACKS. RESULTS: VISUAL INSPECTION FOR CHAMBER REVEALED A CRACK NEAR THE PORT OF THE CHAMBER DOME, WHICH IS CONSISTENT WITH THE CHAMBER HAVING SUSTAINED AN EXTERNAL IMPACT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100708. CONCLUSION: ALL HUMIDIFICATION CHAMBERS ARE PRESSURE TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. IT IS POSSIBLE THE PORT OF THE MR210 CHAMBER SUSTAINED AN IMPACT DURING PRODUCTION BUT WAS TOO SMALL TO BE NOTICED DURING VISUAL INSPECTION AND PRESSURE TESTING. IT IS ALSO POSSIBLE THAT THE CRACK WAS EXACERBATED DURING TRANSPORT. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN MR210 ADULT HUMIDIFICATION CHAMBER WAS FOUND CRACKED ABOUT 22MM LONG NEAR THE CHAMBER PORT. THIS WAS NOTICED RIGHT OUT OF THE BOX, PRIOR TO PATIENT USE. 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 LIMITED MR210 100708

    Patients

    Seq Age Sex Outcome Treatment
    1