BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8 ELITE - AMERICAS

    MDR report key: 2102012 · Received May 20, 2011

    Report

    Report Number
    3004604967-2011-00025
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 20, 2011
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K041209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRELIMINARY EVAL OF THE RETURNED UNIT IDENTIFIED THE POSSIBLE 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 WAS NO ADVERSE EVENT REPORTED FOR THIS INCIDENT. THE INCIDENT AND SEVERITY OF THIS FAILURE TYPE ARE SUBJECTED TO ON-GOING MONITORING.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A CPAP UNIT STARTED SMOKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S8 ELITE - AMERICAS BZD RESMED LTD. 33021

    Patients

    Seq Age Sex Outcome Treatment
    1