BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERFLO OXYGEN CONCENTRATOR

    MDR report key: 10711863 · Received October 21, 2020

    Report

    Report Number
    2518422-2020-02466
    Event Type
    Injury
    Date Received
    October 21, 2020
    Date of Event
    September 3, 2020
    Report Date
    October 21, 2020
    Manufacturer
    PHILIPS RESPIRONICS INC.
    Product Code
    CAW
    PMA / PMN Number
    K061261
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH, REPORT NUMBER 101545-2020-0014, THAT ALLEGED A PATIENT LIT A CIGARETTE WHILE USING AN EVERFLO OXYGEN CONCENTRATOR. THE PATIENT SUFFERED BURNS TO HER FACE AND WAS ADMITTED TO THE HOSPITAL. THE DEVICE IS NOT RETURNING TO THE MANUFACTURER FOR EVALUATION. THE REPORTING FACILITY CONFIRMED THE DEVICE IS IN PATIENT USE WITH NO ISSUES. PRODUCT LABELING STATES,"OXYGEN VIGOROUSLY ACCELERATES COMBUSTION AND SHOULD BE KEPT AWAY FROM HEAT OR OPEN FLAME. NOT SUITABLE FOR USE IN THE PRESENCE OF A FLAMMABLE ANESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE. DO NOT SMOKE, ALLOW OTHERS TO SMOKE OR HAVE OPEN FLAMES NEAR THE CONCENTRATOR WHEN IT IS IN USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176220 EVERFLO OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE CAW PHILIPS RESPIRONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization