BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILLENNIUM OXYGEN CONCENTRATOR

    MDR report key: 5460057 · Received February 25, 2016

    Report

    Report Number
    1040777-2016-00008
    Event Type
    Injury
    Date Received
    February 25, 2016
    Date of Event
    September 7, 2015
    Report Date
    February 1, 2016
    Manufacturer
    RESPIRONICS INC
    Product Code
    CAW
    PMA / PMN Number
    K972614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED A FOLLOW UP REPORT, MDR 1040777-2017-00008. THE CORRECT FOLLOW UP REPORT MDR NUMBER IS 1040777-2016-00008. H6: CODE 1918.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED A PATIENT THAT ALLEGEDLY WAS HOSPITALIZED WITH CARBON MONOXIDE WHILE USING A MILLENNIUM OXYGEN CONCENTRATOR. REPEATED ATTEMPTS TO HAVE THE DEVICE RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WAS HOSPITALIZED WITH CARBON MONOXIDE WHILE USING A MILLENNIUM OXYGEN CONCENTRATOR. 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
    117797 MILLENNIUM OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE CAW RESPIRONICS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization