BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATER FEEDSET EXTENSION

    MDR report key: 3203172 · Received July 2, 2013

    Report

    Report Number
    9611451-2013-00506
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 3, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAW
    PMA / PMN Number
    K953949
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT WATERFEED EXTENSION SET WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED AND CONNECTED TO A WATER BAG AND CHAMBER TO TEST FOR WATER FLOW. RESULTS: NO EXCESSIVE GLUE OR OTHER OCCLUSIONS WERE FOUND IN THE TUBING. THE DUCKBILL HOUSING WAS DISASSEMBLED AND THE DUCKBILL WAS FOUND TO BE SLIT AS EXPECTED. NO EXCESSIVE GLUE WAS FOUND INSIDE THE DUCKBILL HOUSING. DURING THE PERFORMANCE TEST IT WAS OBSERVED THAT NO WATER WAS SUPPLIED TO THE CHAMBER. A LOT CHECK WAS NOT PERFORMED AS A LOT NUMBER WAS NOT PROVIDED. CONCLUSION: THE WATERFEED EXTENSION IS SUPPLIED AS AN ACCESSORY TO THE MR290 AUTOFEED HUMIDIFICATION CHAMBER, GIVING THE USER AN EXTRA 60CM OF TUBING. WE WERE UNABLE TO DETERMINE WHAT WAS CAUSING THE FEEDSET TO MALFUNCTION. VISUAL INSPECTION OF ALL PARTS OF THE FEEDSET ASSEMBLY REVEALED NO ABNORMALITIES. THIS IS THE ONLY COMPLAINT OF THIS NATURE THAT WE HAVE RECEIVED FOR THE 900MR191 WATERFEED EXTENSION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE WATER FEED EXTENSION TUBE FOR THE MR290V HUMIDIFICATION CHAMBER WAS BLOCKED. THIS WAS FOUND BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302369 WATER FEEDSET EXTENSION WATER FEEDSET EXTENSION CAW FISHER & PAYKEL HEALTHCARE LTD 900MR191

    Patients

    Seq Age Sex Outcome Treatment
    1