BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2019410 · Received March 15, 2011

    Report

    Report Number
    9611451-2011-00160
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS CONNECTED TO A WATERBAG FOR TESTING AND WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: THE CHAMBER FILLED TO A NORMAL LEVEL DURING TESTING. WHEN THE WATER FLOW STOPPED, SMALL DROPS OF WATER WERE OBSERVED TO LEAK SLOWLY FROM THE CONNECTION BETWEEN THE WATER FEEDSET TUBE AND THE WATERBAG SPIKE. VISUAL INSPECTION SHOWED THAT INSUFFICIENT AMOUNT OF GLUE HAD BEEN APPLIED BETWEEN THE WATER FEEDSET TUBE AND SPIKE, CAUSING THE REPORTED LEAK. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100326. CONCLUSION: BASED ON VISUAL INSPECTION OF THE FEEDSET TUBE AND WATERBAG SPIKE OF THE RETURNED MR290 CHAMBER, THE LEAK WAS CAUSED BY AN INSUFFICIENT AMOUNT OF GLUE APPLIED. 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." AS PART OF OUR ONGOING PRODUCT IMPROVEMENTS, ADDITIONAL GLUE IS NOW APPLIED TO THE FEEDSET SPIKE DURING PRODUCTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT WATER LEAKED BETWEEN THE WATER FEED TUBE AND SPIKE OF AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER. THIS WAS NOTICED BEFORE PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 100326

    Patients

    Seq Age Sex Outcome Treatment
    1