BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT REUSABLE HUMIDIFICATION CHAMBER

    MDR report key: 3457068 · Received November 7, 2013

    Report

    Report Number
    9611451-2013-00874
    Event Type
    Malfunction
    Date Received
    November 7, 2013
    Report Date
    October 11, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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 FIVE COMPLAINT MR340 HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE'S REGIONAL OFFICE IN (B)(4), WHERE THEY WERE VISUALLY INSPECTED. THE CHAMBERS WERE ALSO TESTED FOR LEAKAGE. RESULTS: THE VISUAL INSPECTION REVEALED THAT THERE WAS NO VISIBLE CRACKING OR OTHER DAMAGE TO THE CHAMBERS. DURING TESTING, IT WAS NOTED THAT THE CHAMBERS WERE LEAKING AT THE SEAL WHERE THE CHAMBER DOME ATTACHES TO THE BASE. OF THE FIVE COMPLAINT DEVICES, ONE CHAMBER WAS FROM LOT DATE 111220 (20 DECEMBER 2011), TWO FROM LOT DATE 111223 (23 DECEMBER 2011) AND THE REMAINING TWO CHAMBERS WERE FROM LOT DATE 120109 (9 JANUARY 2012). A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR THE PROVIDED LOT DATES. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE LEAK, BUT IT IS POSSIBLE THAT THE LEAK WAS CAUSED WHEN THE CHAMBERS WERE BEING CLEANED AT THE USER FACILITY. THE MR340 IS A REUSABLE CHAMBER AND THE BASE IS DESIGNED IN SUCH A WAY THAT IT CAN BE DETACHED FROM THE CHAMBER DOME FOR CLEANING AND THEN RE-ATTACHED. IT IS POSSIBLE FOR RESIDUE OF CLEANING SOLUTION TO GRADUALLY WEAKEN THE PLASTIC OF THE CHAMBER WHICH CAN RENDER THE DEVICE MORE SUSCEPTIBLE TO DAMAGE CAUSED BY, FOR INSTANCE, ACCIDENTAL IMPACT. ALL CHAMBERS ARE PRESSURE TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. OUR USER INSTRUCTIONS SPECIFIES RECOMMENDED METHODS FOR CLEANING THE CHAMBER AS WELL AS A WARNING AGAINST UTILISING SOLUTIONS CONTAINING PARTICULAR COMPOUNDS THAT MAY WEAKEN THE CHAMBER. OUR USER INSTRUCTIONS ALSO SPECIFY: -"TO PREVENT CRACKING, ENSURE THAT THE WATER INLET PORT PLUG, AND ANY OTHER REUSABLE COMPONENTS, ARE DISCONNECTED FROM THE CHAMBER BEFORE CLEANING." DEVICE EVALUATED BY REGIONAL OFFICE.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT FIVE MR340 REUSABLE HUMIDIFICATION CHAMBERS WERE LEAKING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575189 INFANT REUSABLE HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR340

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL HEALTHCARE MR810 HUMIDIFIER