BEUDAMED
    FDA Adverse Event Death Summary report: N

    MILLENNIUM OXYGEN CONCENTRATOR

    MDR report key: 7303282 · Received February 28, 2018

    Report

    Report Number
    1040777-2018-00011
    Event Type
    Death
    Date Received
    February 28, 2018
    Date of Event
    November 29, 2017
    Report Date
    February 26, 2018
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CAW
    UDI-DI
    00606959015678
    PMA / PMN Number
    K043006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER PREVIOUSLY REPORTED A MILLENNIUM M10 OXYGEN CONCENTRATOR WAS ALLEGEDLY INVOLVED IN A HOUSE FIRE. THE PATIENT EXPIRED. THE DEVICE WAS EVALUATED BY A THIRD PARTY INVESTIGATION. THE THIRD PARTY INVESTIGATOR CONFIRMS THE MILLENNIUM OXYGEN CONCENTRATOR WAS NOT THE ORIGIN OF THE FIRE. THE FIRE DID NOT ORIGINATE IN THE ROOM WHERE THE OXYGEN CONCENTRATOR WAS BEING USED. THE TRAIL LEFT IN THE CARPET FROM THE BURNING CANNULA INDICATES THE DEVICE WAS OPERATING AND PRODUCING OXYGEN AS MANUFACTURED AT THE TIME OF THE EVENT. THE MANUFACTURER CONCLUDES THE FIRE ORIGINATED FROM AN EXTERNAL SOURCE.

    Additional Manufacturer Narrative · 1

    EVALUATION CONCLUSION: THIS EVENT WAS ALSO REPORTED ON MDR 1040777-2018-00009. THIS EVENT INVOLVED 2 PEOPLE.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A MILLENNIUM OXYGEN CONCENTRATOR THAT WAS INVOLVED IN A HOUSE FIRE. THE CARETAKER EXPIRED. 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
    145617 MILLENNIUM OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE CAW RESPIRONICS, INC. M10600 00606959015678

    Patients

    Seq Age Sex Outcome Treatment
    1 Death