BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILLENNIUM M10 OXYGEN CONCENTRATOR

    MDR report key: 3950541 · Received July 10, 2014

    Report

    Report Number
    1040777-2014-00016
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CAW
    PMA / PMN Number
    K043006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A MILLENIUM M10 OXYGEN CONCENTRATOR WAS NOT PROVIDING THE PRESCRIBED OXYGEN. THE PATIENT REPORTEDLY FELL AND WAS ADMITTED TO THE HOSPITAL FOR EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403848 MILLENNIUM M10 OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE CAW RESPIRONICS, INC. M10600

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization