BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8 ELITE - AMERICAS

    MDR report key: 3023290 · Received February 28, 2013

    Report

    Report Number
    3004604967-2013-00005
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 28, 2013
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K041209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESMED HAS REQUESTED THE DEVICE BE RETURNED SO AN ENGINEERING INVESTIGATION COULD BE PERFORMED. SINCE THE DEVICE HAS NOT YET BEEN RETURNED, RESMED IS UNABLE TO CONFIRM THE COMPLAINT OR DETERMINE THE CAUSE OF THE 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 AN S8 DEVICE CAUGHT FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88979 S8 ELITE - AMERICAS BZD RESMED LTD. 33021

    Patients

    Seq Age Sex Outcome Treatment
    1