BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8 AUTOSET VANTAGE -AMERICAS

    MDR report key: 3041203 · Received April 2, 2013

    Report

    Report Number
    3004604967-2013-00011
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 2, 2013
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K041209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENGINEERING INVESTIGATION OF THE RETURNED UNIT IDENTIFIED THE ROOT CAUSE OF THE FAILURE AS THE AC APPLIANCE INLET CONNECTOR. THE RESULT OF THIS FAILURE WAS A BRIEF EXTERNAL FLAME THAT SELF ARRESTED AND DID NOT REQUIRE EXTERNAL INTERVENTION. THERE IS NO ADVERSE EVENT REPORTED FOR THIS INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT AN S8 AUTOSET VANTAGE WAS SMOKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135343 S8 AUTOSET VANTAGE -AMERICAS BZD RESMED LTD. 33112

    Patients

    Seq Age Sex Outcome Treatment
    1