BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2343044 · Received November 20, 2011

    Report

    Report Number
    9611451-2011-00721
    Event Type
    Malfunction
    Date Received
    November 20, 2011
    Date of Event
    October 20, 2011
    Report Date
    October 25, 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 MR290V CHAMBER WAS VISUALLY INSPECTED, PERFORMANCE TESTED AND IMMERSED IN A WATER BATH TO CHECK FOR LEAKS. RESULTS: THE PRESSURE TEST REVEALED A LEAK IN THE CHAMBER AND IMMERSION IN THE WATER BATH SHOWED THE LOCATION OF THE LEAK WAS AT THE CONNECTION BETWEEN THE WATER FEEDSET TUBE AND THE CHAMBER DOME. THE VISUAL INSPECTION REVEALED THAT THERE WAS GLUE EVENLY DISTRIBUTED AROUND THE CONNECTION, BUT THAT THE GLUE BOND APPEARED TO HAVE FAILED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110428. CONCLUSION: SUFFICIENT GLUE WAS FOUND TO HAVE BEEN APPLIED TO THE FEEDSET TUBE WHERE IT CONNECTS TO THE CHAMBER DOME, HOWEVER THE LEAK AT THIS LOCATION INDICATED THAT THE GLUE HAD NOT ADEQUATELY BONDED. AS PART OF OUR MANUFACTURING PROCESS, EVERY MR290 CHAMBER UNDERGOES PRESSURE TESTING FOR POTENTIAL LEAKS AND THOSE THAT FAIL ARE REJECTED. IT IS AN AUTOMATED PROCESS AND THE COMPLAINT CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THIS SUGGESTS THAT THE GLUE BOND FAILED 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." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AIR LEAKED FROM THE WATER FEEDSET OF AN MR290 AUTOFEED HUMIDIFICATION CHAMBER WHERE IT CONNECTS TO THE CHAMBER. THIS WAS FOUND DURING THE VENTILATOR LEAK TEST, BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 110428

    Patients

    Seq Age Sex Outcome Treatment
    1