BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2086148 · Received May 12, 2011

    Report

    Report Number
    9611451-2011-00295
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 29, 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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MR290V VENTED HUMIDIFICATION CHAMBER IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED MR290V CHAMBER WAS VISUALLY INSPECTED AND PRESSURE TESTED TO DETERMINE THE ROOT CAUSE OF THE REPORTED LEAK. RESULTS: PRESSURE TEST RESULT WAS OUTSIDE THE REQUIRED SPECIFICATION. UPON IMMERSION OF THE CHAMBER IN A WATERBATH, THE LEAK WAS FOUND TO BE EVENLY SPREAD AROUND THE SEAL BETWEEN THE CHAMBER DOME AND ALUMINIUM BASE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100819. CONCLUSION: EVERY MR290 CHAMBER IS PRESSURE TESTED TO 200CMH20 FOLLOWING THE PRODUCTION PROCESS WHICH DETECTS POTENTIAL LEAKS DUE TO CRACKS AND OTHER SOURCES. ANY CHAMBER WHICH FAILS THE PRODUCTION LEAK TEST IS REJECTED. IT IS POSSIBLE THAT THE COMPLAINT CHAMBER WAS NOT PROPERLY ASSEMBLED ON THE PRODUCTION LINE WHICH MAY HAVE CONTRIBUTED TO THE FORMATION OF A WEAKER SEAL BETWEEN THE GASKET AND THE LIP OF THE CHAMBER DOME. ALTHOUGH THE SUBJECT CHAMBER PASSED POST-PRODUCTION LEAK TESTS, IT IS POSSIBLE THE WEAKER SEAL WAS EXACERBATED WHEN THE CHAMBER WAS SUBJECTED TO HEAT FROM THE HEATER BASE. OUR USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER SPECIFIES TO THE USER TO PERFORM A PRESSURE AND LEAK TEST ON THE SYSTEM PRIOR TO USE. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT WATER LEAKED FROM THE BASE OF AN MR290V VENTED HUMIDIFICATION CHAMBER AFTER ABOUT A WEEK OF USING ON A PATIENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT WATER LEAKED FROM THE BASE OF AN MR290V VENTED HUMIDIFICATION CHAMBER AFTER ABOUT A WEEK OF USING ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 100819

    Patients

    Seq Age Sex Outcome Treatment
    1