BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8 COMPACT - AMERICAS

    MDR report key: 859598 · Received June 1, 2007

    Report

    Report Number
    3004604967-2007-00003
    Event Type
    Malfunction
    Date Received
    June 1, 2007
    Date of Event
    May 4, 2007
    Report Date
    May 24, 2007
    Manufacturer
    RESMED LTD.
    Product Code
    MNS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS WITHIN THE SERIAL NUMBER RANGE OF A CURRENT RESMED RECALL. UPON EXAMINATION, THE DEVICE WAS CONFIRMED TO HAVE THE AC CONNECTOR PROBLEM, THE REASON FOR THE RECALL.

    Description of Event or Problem · 1

    UF CALLED RESMED CORP. CUSTOMER SERVICE DEPARTMENT AND REPORTED THAT THE UNIT "FLAMED OUT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S8 COMPACT - AMERICAS S8 FLOW GENERATOR MNS RESMED LTD. 33030

    Patients

    Seq Age Sex Outcome Treatment
    1 YR