BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8 COMPACT - AMERICAS

    MDR report key: 3913004 · Received June 26, 2014

    Report

    Report Number
    3004604967-2014-00014
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Manufacturer
    RESMED LTD
    Product Code
    BZD
    PMA / PMN Number
    K033841
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENGINEERING INVESTIGATION OF THE RETURNED UNIT IDENTIFIED THE ROOT CAUSE OF THE FAILURE AS THE AC APPLIANCE INLET CONNECTOR. THE RESULT OF THIS FAILURE WAS A BRIEF EXTERNAL FLAME THAT SELF-ARRESTED AND DID NOT REQUIRE EXTERNAL INTERVENTION. THERE WAS NO PT INJURY REPORTED FOR THIS INCIDENT. RESMED WAS CONDUCTED ONGOING, INTENSIVE MONITORING AND STATISTICAL ANALYSIS OF THE EMPIRICAL FIELD RETURN DATA FOR THIS FAILURE MODE. RESMED'S RISK ANALYSIS CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED CONTINUES TO CLOSELY MONITOR THE INCIDENT AND SEVERITY OF THIS FAILURE TYPE.

    Description of Event or Problem · 1

    REF IMP # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373041 S8 COMPACT - AMERICAS BZD RESMED LTD

    Patients

    Seq Age Sex Outcome Treatment
    1