BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8 ELITE II AMERICA

    MDR report key: 2983227 · Received February 1, 2013

    Report

    Report Number
    3004604967-2013-00002
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K071171
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRELIMINARY EVALUATION OF THE RETURNED UNIT FOUND EVIDENCE OF WATER DAMAGE TO THE INSIDE AND OUTSIDE OF THE DEVICE. A POSSIBLE CAUSE OF THE FAILURE WAS WATER INGRESS LEADING TO A SHORT CIRCUIT OF THE POWER SUPPLY UNIT. THE DEVICE HAS BEEN SENT TO THE DESIGN FACILITY IN SYDNEY AUSTRALIA FOR AN ENGINEERING INVESTIGATION TO CONFORM THE CAUSE OF THE MALFUNCTION. THERE IS NO ADVERSE EVENT REPORTED FOR THIS INCIDENT. ADDITIONALLY, THE S8 ELITE II USER GUIDE CONTAINS A CAUTION: BE CAREFUL TO PLACE THE DEVICE WHERE IT CANNOT BE BUMPED AND WHERE NO ONE WILL TRIP OVER THE POWER CORD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT AN S8 DEVICE BOTTOM CASING WAS BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45324 S8 ELITE II AMERICA BZD RESMED LTD. 33039

    Patients

    Seq Age Sex Outcome Treatment
    1