BEUDAMED
    FDA Adverse Event Death Summary report: N

    MILLENNIUM M10

    MDR report key: 3062764 · Received April 11, 2013

    Report

    Report Number
    1040777-2013-00005
    Event Type
    Death
    Date Received
    April 11, 2013
    Date of Event
    February 23, 2013
    Report Date
    February 23, 2013
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CAW
    PMA / PMN Number
    K043006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ALLEGING A PT EXPIRED WHILE USING A MILLENNIUM M10 OXYGEN CONCENTRATOR. THE DEVICE IS NOT PRESENTLY BEING RELEASED BY THE PATIENT'S FAMILY. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155102 MILLENNIUM M10 GENERATOR, OXYGEN, PORTABLE CAW RESPIRONICS, INC. M10600 M10600

    Patients

    Seq Age Sex Outcome Treatment
    1 Death