BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVERFLO OXYGEN CONCENTRATOR

    MDR report key: 11607148 · Received April 2, 2021

    Report

    Report Number
    2518422-2021-00957
    Event Type
    Death
    Date Received
    April 2, 2021
    Date of Event
    March 29, 2021
    Report Date
    June 9, 2021
    Manufacturer
    PHILIPS RESPIRONICS INC.
    Product Code
    CAW
    UDI-DI
    00606959032774
    PMA / PMN Number
    K061261
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN EVERFLO OXYGEN CONCENTRATOR MAY HAVE BEEN INVOLVED IN AN ALLEGED HOUSE FIRE. THE PATIENT EXPIRED. 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 AN EVERFLO OXYGEN CONCENTRATOR MAY HAVE BEEN INVOLVED IN A HOUSE FIRE. THE PATIENT EXPIRED. THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE FILED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506670 EVERFLO OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE CAW PHILIPS RESPIRONICS INC. 1020020 00606959032774

    Patients

    Seq Age Sex Outcome Treatment
    1 Death