BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 3011877 · Received March 19, 2013

    Report

    Report Number
    9611451-2013-00057
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 4, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT CHAMBER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RETURNED COMPLAINT CHAMBER WAS CONNECTED TO A WATERBAG FOR FUNCTIONAL TESTING. RESULTS: WHEN THE COMPLAINT CHAMBER WAS CONNECTED TO A WATERBAG, A DROP OF WATER WAS OBSERVED TO LEAK FROM THE CONNECTION BETWEEN THE FEEDSET TUBE AND WATERBAG SPIKE OF THE CHAMBER. ADEQUATE GLUE WAS FOUND ON THE FEEDSET TUBE/SPIKE CONNECTION BUT THE GLUE WAS NOT BONDING. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: WE WERE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED FAULT. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. THIS SUGGESTS THAT THE THE SPIKE BECAME LOOSE POST PRODUCTION, LIKELY AS A RESULT OF FAILURE OF THE GLUE BOND THAT JOINS THE SPIKE TO THE WATER FEEDSET TUBE. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER STATE THE FOLLOWING: "SET APPROPRIATE VENTILATOR ALARM." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT WATER LEAKED AT THE CONNECTION BETWEEN THE WATER FEED TUBE AND THE BAG SPIKE OF AN MR290 AUTOFEED HUMIDIFICATION CHAMBER DURING THE SECOND DAY OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113880 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290 120602

    Patients

    Seq Age Sex Outcome Treatment
    1