BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT REUSABLE HUMIDIFICATION CHAMBER

    MDR report key: 2294645 · Received October 13, 2011

    Report

    Report Number
    9611451-2011-00637
    Event Type
    Malfunction
    Date Received
    October 13, 2011
    Report Date
    September 22, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K913368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR340 HUMIDIFICATION CHAMBERS WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4), WHERE IT WAS VISUALLY INSPECTED. THE CHAMBER WAS ALSO TESTED FOR LEAKAGE. RESULTS: THE VISUAL INSPECTION REVEALED THAT THERE WAS NO VISIBLE CRACKING OR OTHER DAMAGE TO THE CHAMBER. A WHITE/BROWNISH DEPOSIT WAS EVIDENT INSIDE THE DOME AND ON THE BASE OF THE CHAMBER. IN GENERAL, THE CHAMBER SHOWED EVIDENCE OF HAVING BEEN WELL USED. DURING TESTING IT WAS NOTED THAT THE CHAMBER WAS LEAKING AT THE SEAL WHERE THE CHAMBER DOME ATTACHES TO THE BASE. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT NUMBER 100614. CONCLUSION: BASED ON THE AGE OF THE CHAMBER (15 MONTHS) AND THE FACT THAT IT APPEARED WELL USED, IT IS LIKELY THAT THE SEAL BETWEEN THE DOME AND BASE HAD WEAKENED WITH TIME AND USE. THE BASE IS DESIGNED IN SUCH A WAY THAT IT CAN BE DETACHED FROM THE CHAMBER FOR CLEANING AND IS THEN RE-ATTACHED. ALL CHAMBERS ARE PRESSURE TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. WE HAVE ONLY RECEIVED ONE OTHER COMPLAINT OF THIS TYPE IN THE PAST 12 MONTHS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN MR340 INFANT REUSABLE HUMIDIFICATION CHAMBER WAS LEAKING DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT REUSABLE HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR340 100614

    Patients

    Seq Age Sex Outcome Treatment
    1