BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVERFLO OXYGEN CONCENTRATOR

    MDR report key: 11931538 · Received June 3, 2021

    Report

    Report Number
    2518422-2021-01627
    Event Type
    Death
    Date Received
    June 3, 2021
    Date of Event
    January 17, 2019
    Report Date
    September 1, 2021
    Manufacturer
    PHILIPS RESPIRONICS INC.
    Product Code
    CAW
    UDI-DI
    00606959014954
    PMA / PMN Number
    K061261
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED A PATIENT ALLEGED RECEIVED BURNS TO HER FACE AND NECK FROM A HOUSE FIRE AND EXPIRED AT A LATER DATE. THE DEVICE IS NOT RETURNING TO THE MANUFACTURER FOR EVALUATON.. 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 RECEIVED BURNS TO HER FACE AND NECK FROM A HOUSE FIRE AND EXPIRED AT A LATER DATE. IT WAS REPORTED THAT 2 EVERFLO OXYGEN CONCENTRATORS WERE IN THE HOUSE AT THE TIME OF THE FIRE. IT IS UNKNOWN WHICH DEVICE WAS BEING USED AT THE TIME OF THE EVENT. THE EVERFLO OXYGEN CONCENTRATOR SERIAL NUMBER (B)(4) WAS REPORTED ON MDR 2518422-2021-01625. THE INVESTIGATION IS STILL ONGOING. 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
    824288 EVERFLO OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE CAW PHILIPS RESPIRONICS INC. 1020000 00606959014954

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death