BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2362634 · Received December 7, 2011

    Report

    Report Number
    9611451-2011-00763
    Event Type
    Malfunction
    Date Received
    December 7, 2011
    Date of Event
    October 31, 2011
    Report Date
    November 15, 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 TWO RETURNED COMPLAINT MR290 CHAMBERS WERE VISUALLY INSPECTED AND CONNECTED TO A WATER BAG FOR TESTING. RESULTS: DURING PERFORMANCE TESTING OF BOTH CHAMBERS SMALL DROPS OF WATER BEGAN TO BUILD UP AT THE CONNECTION BETWEEN THE WATER FEEDSET TUBE AND SPIKE. VISUAL INSPECTION REVEALED THAT SUFFICIENT GLUE WAS PRESENT AROUND THE SPIKE TUBING CONNECTION, BUT THAT THE GLUE WAS ONLY PARTIALLY BONDED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110421. 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, 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 VIA OUR DISTRIBUTOR THAT WATER LEAKED BETWEEN THE WATER FEED TUBE AND THE BAG SPIKE ON TWO MR290 AUTOFEED HUMIDIFICATION CHAMBERS DURING PATIENT USE. THE TWO INCIDENTS OCCURRED ON (B)(6) 2011. 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 110421

    Patients

    Seq Age Sex Outcome Treatment
    1