BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8 AUTOSET VANTAGE - AMERICAS

    MDR report key: 1372327 · Received February 20, 2009

    Report

    Report Number
    3004604967-2009-00002
    Event Type
    Malfunction
    Date Received
    February 20, 2009
    Date of Event
    December 2, 2008
    Report Date
    February 19, 2009
    Product Code
    BZD
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POWER SUPPLY MODULE CAUSED THERMAL DAMAGE WITH EVIDENCE OF EXTERNAL FLAME. REASON FOR DELAY IN REPORTING: -ON 02-DEC-2008, THE COMPLAINT UNIT WAS RECEIVED AT RESMED CORP TO INFORM RESMED OF A UNIT WITH A SYSTEM ERROR. ON 22-DEC-2008, THE COMPLAINANT UNIT WAS RECEIVED AT RESMED CORP, AND PRELIMINARY INVESTIGATION WAS PERFORMED. BASED ON THE PRELIMINARY INVESTIGATION IT WAS DETERMINED FURTHER EVALUATION SHOULD BE PERFORMED AT DESIGN FACILITY IN SYDNEY AUSTRALIA THEREFORE, UNIT WAS SHIPPED TO DESIGN ENGINEERING. -ON 01-FEB-2009, DESIGN ENGINEERING COMPLETED THEIR INVESTIGATION CONCLUDING THE EVENT MET THE RESMED CRITERIA FOR REPORTABILITY.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO RESMED FOR A "SYSTEM ERROR". VISUAL INSPECTION OF THE UNIT SHOWED EVIDENCE OF EXTERNAL FLAME. RESMED DETERMINED THE EVENT MAY BE REPORTABLE ON 01-FEB-2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S8 AUTOSET VANTAGE - AMERICAS S8 AUTOSET VANTAGE - AMERICAS BZD 33112 154638

    Patients

    Seq Age Sex Outcome Treatment
    1