BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8 VANTAGE - AMERICAS

    MDR report key: 2971447 · Received July 6, 2007

    Report

    Report Number
    3004604967-2007-00005
    Event Type
    Malfunction
    Date Received
    July 6, 2007
    Date of Event
    June 8, 2007
    Report Date
    July 2, 2007
    Manufacturer
    RESMED LTD. BELLA VISTA
    Product Code
    BZD
    Removal / Correction Number
    Z-1006-2007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS WITHIN THE SERIAL NUMBER RANGE OF A CURRENT RESMED RECALL (RECALL#: Z-1006-2007). UPON EXAMINATION, THE DEVICE WAS CONFIRMED TO HAVE THE AC CONNECTOR PROBLEM, THE REASON FOR THE RECALL. DEVICE IS LISTED WITHIN THE SERIAL NUMBER RANGE.

    Description of Event or Problem · 1

    (B)(6) FROM (B)(6), INFORMED RESMED CUSTOMER SERVICE DEPARTMENT THAT A RECALL UNIT CAUGHT FIRE AND CAUSED PROPERTY DAMAGE. (SLIGHT BURN ON CARPET, ACCORDING TO PT.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S8 VANTAGE - AMERICAS S8 FLOW GENERATOR BZD RESMED LTD. BELLA VISTA 33112

    Patients

    Seq Age Sex Outcome Treatment
    1