BEUDAMED
    FDA Adverse Event Death Summary report: N

    S9 VPAP AUTO - AMERICAS

    MDR report key: 3760677 · Received April 10, 2014

    Report

    Report Number
    3004604967-2014-00010
    Event Type
    Death
    Date Received
    April 10, 2014
    Date of Event
    March 8, 2014
    Report Date
    April 10, 2014
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K102513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT A PT USING A S9 VPAP AUTO PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216202 S9 VPAP AUTO - AMERICAS BZD RESMED LTD. 36006

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death