BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR/OXYGEN FLOWMETER MODULE

    MDR report key: 2005087 · Received March 2, 2011

    Report

    Report Number
    9611451-2011-00110
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Report Date
    January 31, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE 900IW111 WAS RELEASED WITH AN IW932AEK INFANT WARMER. (SERIAL NUMBER: (B)(4), LOT NUMBER: 100929, DATE OF MANUFACTURE: 29 SEPTEMBER 2010, 510(K) NUMBER: K971695). METHOD: THE COMPLAINT FLOW METER WAS FLOW TESTED. RESULTS: THE FLOW OUTPUT FROM THE FLOW METER WAS LOWER THAN THE MAXIMUM EXPECTED FLOW. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100927. CONCLUSION: THE ROOT CAUSE OF THE FLOW RESTRICTION WAS FOUND TO BE AN OCCLUSION ON THE FILTER. THE OCCLUSION WAS CAUSED BY AN ACCUMULATION OF FOREIGN PARTICLES. THE UNIT PASSED ALL RELEVANT FUNCTIONAL TESTS AFTER THE FILTER WAS REPLACED. THIS FAULT WOULD HAVE BEEN EVIDENT TO THE END USER AS THE LOW OUTPUT WOULD SHOW ON THE FLOW INDICATOR. THE DEVICE RECORDS SHOW THAT THE FLOW METER PASSED PRESSURE LEAK AND FLOW CHECKS PRIOR TO DISTRIBUTION. THE OCCLUSION OF THE FILTER WOULD HAVE OCCURRED POST-PRODUCTION, DURING USE OF THE PRODUCT. A REPLACEMENT DEVICE HAS BEEN PROVIDED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    (B)(4).THE COMPLAINT DEVICE HAS NOT YET BEEN RECEIVED BY FISHER & PAYKEL HEALTHCARE FOR EVALUATION.WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT A 900IW111 OXYGEN AND AIR FLOWMETER MODULE COULD NOT OBTAIN AN OXYGEN FLOW OVER 5 LITERS. NO PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT A (B)(4) OXYGEN & AIR FLOWMETER MODULE COULD NOT OBTAIN AN OXYGEN FLOW OVER 5 LITERS.NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR/OXYGEN FLOWMETER MODULE BYX BTT FISHER & PAYKEL HEALTHCARE LIMITED 900IW111 100927

    Patients

    Seq Age Sex Outcome Treatment
    1