BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1565780 · Received December 22, 2009

    Report

    Report Number
    9611451-2009-00722
    Event Type
    Malfunction
    Date Received
    December 22, 2009
    Date of Event
    October 20, 2009
    Report Date
    November 25, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT202 ADULT BREATHING CIRCUIT KIT CONTAINS AN MR290 AUTOFEED HUMIDIFICATION CHAMBER. THE 510 (K) NUMBER FOR THE RT202 ADULT BREATHING CIRCUIT KIT IS K983112. METHOD: THE RETURNED RT202 BREATHING CIRCUIT AND ASSOCIATED MR290 CHAMBER WERE TESTED FOR LEAKS. RESULTS: ALTHOUGH THE RT202 BREATHING CIRCUIT DID NOT LEAK, PRESSURE TESTING REVEALED A LEAK BETWEEN THE DOME AND ALUMINUM BASE OF THE MR290 CHAMBER. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 090926. 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 THAT A NEW RT202 ADULT BREATHING CIRCUIT KIT HAD A LEAK. THE LEAK WAS NOTICED BY HOSPITAL STAFF BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR290V 090926

    Patients

    Seq Age Sex Outcome Treatment
    1