BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8 AUTOSET SPIRIT

    MDR report key: 2251668 · Received August 31, 2011

    Report

    Report Number
    3004604967-2011-00043
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    July 11, 2011
    Report Date
    August 31, 2011
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K041209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO ADVERSE EVENT REPORTED FOR THIS INCIDENT. THE ENGINEERING EVAL OF THE RETURNED UNIT IDENTIFIED THE ROOT CAUSE OF THE FAILURE AS THE AC APPLIANCE INLET CONNECTOR SOLDER JOINT IN THE POWER SUPPLY UNIT. THE RESULT OF THIS FAILURE WAS A BRIEF EXTERNAL FLAME THAT SELF-ARRESTED AND DID NOT REQUIRE EXTERNAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MFR THAT AN S8 DEVICE BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S8 AUTOSET SPIRIT BZD RESMED LTD. 33122

    Patients

    Seq Age Sex Outcome Treatment
    1