BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3034091 · Received April 4, 2013

    Report

    Report Number
    9611451-2013-00234
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 5, 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 MR290 AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. IT WAS VISUALLY INSPECTED AND CONNECTED TO A WATER BAG TO TEST FOR THE REPORTED LEAK. RESULTS: UPON CONNECTION TO A WATER BAG, WATER LEAKED FROM THE VENT OF THE BAG SPIKE ON THE RETURNED MR290 CHAMBER, CONFIRMING THE REPORTED FAULT. VISUAL INSPECTION REVEALED THAT THE VENT FILTER WAS NOT SEALED IN ONE AREA. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 120702. CONCLUSION: THE SEAL OF THE VENT FILTER WAS NOT SEALED SUFFICIENTLY CAUSING THE REPORTED LEAK. 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. THE USER INSTRUCTIONS THAT ACCOMPANY THE MR290 STATE THE FOLLOWING: "SET APPROPRIATE VENTILATOR ALARMS." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THERE WAS A WATER LEAK FROM THE VENT VALVE ON AN MR290 AUTOFEED HUMIDIFICATION CHAMBER THIS WAS FOUND AFTER ONE DAY OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139507 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 120702

    Patients

    Seq Age Sex Outcome Treatment
    1