BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8 ELITE - AMERICAS

    MDR report key: 1882871 · Received October 22, 2010

    Report

    Report Number
    3004604967-2010-00037
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 22, 2010
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K041209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO RESMED FOR AN EVALUATION. RESMED HAS REQUESTED THE DEVICE BE RETURNED SO THAT AN ENGINEERING EVALUATION COULD BE PERFORMED. THERE WAS NO ADVERSE EVENT REPORTED FOR THIS INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CPAP UNIT WAS BLACKENED BY SMOKE.

    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