BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8 AUTOSET VANTAGE - AMERICAS

    MDR report key: 1600787 · Received February 3, 2010

    Report

    Report Number
    3004604967-2010-00005
    Event Type
    Malfunction
    Date Received
    February 3, 2010
    Date of Event
    January 3, 2010
    Report Date
    February 3, 2010
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K041209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY EXAMINATION OF THIS DEVICE INDICATES THAT THE DEVICE FAILED WITH THE POSSIBILITY OF A BRIEF EXTERNAL FLAME. THE DEVICE HAS BEEN RETURNED TO THE MFR (RESMED LTD) IN (B)(4) FOR A FULL INVESTIGATION. THERE WAS NO ADVERSE EVENT REPORTED FOR THIS INCIDENT.

    Description of Event or Problem · 1

    A RESMED CPAP UNIT WAS REPORTED TO HAVE CAUGHT ON FIRE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1