BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2254725 · Received September 20, 2011

    Report

    Report Number
    9611451-2011-00585
    Event Type
    Malfunction
    Date Received
    September 20, 2011
    Date of Event
    June 18, 2011
    Report Date
    August 30, 2011
    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 RETURNED COMPLAINT MR290 CHAMBER WAS VISUALLY INSPECTED AND CONNECTED TO A WATER BAG FOR TESTING. RESULTS: THE CHAMBER FILLED TO THE EXPECTED FILL LEVEL, AND SMALL DROPS OF WATER BEGAN TO BUILD UP AT THE CONNECTION BETWEEN THE FEEDSET TUBE AND THE WATER BAG SPIKE. VISUAL INSPECTION REVEALED THAT GLUE WAS PRESENT AROUND THE SPIKE TUBING CONNECTION. 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 LEAK DEVELOPED POST PRODUCTION, POSSIBLY AS A RESULT OF FAILURE OF THE GLUE BOND THAT JOINS THE SPIKE TO THE WATER FEEDSET TUBE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS TYPE FOR LOT 110426. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER STATE "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 FEEDSET TUBE AND THE BAG SPIKE OF AN MR290 AUTOFEED HUMIDIFICATION CHAMBER DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 110426

    Patients

    Seq Age Sex Outcome Treatment
    1