BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1548145 · Received November 17, 2009

    Report

    Report Number
    9611451-2009-00601
    Event Type
    Malfunction
    Date Received
    November 17, 2009
    Report Date
    October 19, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED MR290 AUTOFEED HUMIDIFICATION CHAMBER WAS VISUALLY INSPECTED. RESULTS: A SPLIT WAS OBSERVED IN THE FEEDSET TUBING. THE SPLIT WAS LOCATED NEAR THE END OF THE TUBING WHERE IT CONNECTS TO THE CHAMBER DOME. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 090703. CONCLUSION: THE DRIPPING WATER OBSERVED BY THE HOSPITAL ORIGINATED FROM A SPLIT IN THE TUBING THAT TRANSPORTS WATER FROM A WATER BAG TO THE MR290 AUTOFEED HUMIDIFICATION CHAMBER. ALL HUMIDIFICATION CHAMBERS ARE PRESSURE TESTED DURING THE PRODUCTION PROCESS. ALL CHAMBERS THAT FAIL THE PRESSURE TEST ARE REJECTED. IF THE FEEDSET LINE HAD BEEN SPLIT DURING PRODUCTION, THE COMPLAINT CHAMBER WOULD HAVE FAILED THE PRESSURE TEST AND BEEN REJECTED. FURTHERMORE, THE LEAK WAS OBSERVED DURING USE WHICH SUGGESTS THAT THE FEEDSET TUBING WAS SPLIT DURING USE. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THEY SAW WATER DRIPPING FROM THE HUMIDIFIER. THE TRACED THE WATER BACK TO THE CONNECTION BETWEEN THE FEEDSET TUBING AND THE MR290 AUTOFEED HUMIDIFICATION CHAMBER THAT WERE USED IN THE SET-UP. THE PATIENT WAS PLACED ON A NEOPUFF INFANT RESUSCITATOR WHILE THE BREATHING CIRCUIT AND HUMIDIFICATION CHAMBER WERE REPLACED. THE HOSPITAL REPORTED THAT THEY ARE NOT ABLE TO DETERMINE FOR HOW LONG THE CHAMBER HAD BEEN IN USE, BUT IT WAS REPORTED THAT THE "WATER PUDDLE ON THE FLOOR WAS QUITE SMALL." NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR290 090703

    Patients

    Seq Age Sex Outcome Treatment
    1