BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8 ELITE - AMERICAS

    MDR report key: 2881177 · Received November 15, 2012

    Report

    Report Number
    3004604967-2012-00046
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 1, 2012
    Report Date
    November 15, 2012
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K041209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT AN ENGINEERING INVESTIGATION COULD BE PERFORMED. THE DEVICE HAS NOT YET BEEN RETURNED, THEREFORE, RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. THERE WAS NO ADVERSE EVENT REPORTED FOR THIS INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT A PT USING AN S8 ELITE FLOW GENERATOR SAW FLAMES ON THE POWER SUPPLY.

    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