BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8 ELITE - AMERICAS

    MDR report key: 1376122 · Received February 25, 2009

    Report

    Report Number
    3004604967-2009-00006
    Event Type
    Malfunction
    Date Received
    February 25, 2009
    Date of Event
    November 20, 2008
    Report Date
    February 24, 2009
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POWER SUPPLY MODULE CAUSED THERMAL DAMAGE WITH EVIDENCE OF EXTERNAL FLAME. ON THE EVENT DATE, THE CUSTOMER CONTACTED RESMED CORP. TO INFORM RESMED THAT UNIT "STARTED ON FIRE WHEN PLUGGED IN." THE FOLLOWING MONTH, THE COMPLAINT UNIT WAS RECEIVED AT RESMED CORP. AND PRELIMINARY INVESTIGATION WAS PERFORMED. BASED ON PRELIMINARY INVESTIGATION IT WAS DETERMINED FURTHER EVAL SHOULD BE PERFORMED AT DESIGN FACILITY; THEREFORE, UNIT WAS SHIPPED TO DESIGN ENGINEERING. ON 22JAN2009 DESIGN ENGINEERING COMPLETED THEIR INVESTIGATION CONCLUDING THE EVENT MET THE RESMED CRITERIA FOR REPORTABILITY.

    Description of Event or Problem · 1

    THE DME STATED THAT THE UNIT STARTED ON FIRE WHEN PLUGGED IN. RESMED DETERMINED THE EVENT MAY BE REPORTABLE IN 2009.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1