BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8 ELITE - AMERICAS

    MDR report key: 2962041 · Received January 23, 2013

    Report

    Report Number
    3004604967-2013-00001
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 23, 2013
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K041209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 WAS AWAKENED IN THE MIDDLE OF THE NIGHT WHEN HIS S8 DEVICE MADE A LOUD BANG AND HE SAW BLUE FLAMES COMING OUT OF THE DEVICE NEAR THE MOTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33234 S8 ELITE - AMERICAS BZD RESMED LTD. 33021

    Patients

    Seq Age Sex Outcome Treatment
    1