BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERFLO

    MDR report key: 17516267 · Received August 11, 2023

    Report

    Report Number
    MW5123216
    Event Type
    Injury
    Date Received
    August 11, 2023
    Report Date
    June 7, 2012
    Manufacturer
    PHILIPS-RESPIRONICS
    Product Code
    CAW
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    LNOGEN INC., HAS RECEIVED NOTIFICATION OF A POTENTIALLY REPORTABLE MEDICAL EVENT REGARDING PATIENT USE OF A STATIONARY OXYGEN CONCENTRATOR MEDICAL DEVICE THAT IS NOT MANUFACTURED BY LNOGEN. PATIENT WAS ADMITTED TO HOSPITAL EMERGENCY ROOM ON (B)(6) 2012 WITH FIRST AND SECOND DEGREE BURNS TO THE MID-FACE DUE TO THIS EVENT. THE STATIONARY OXYGEN CONCENTRATOR IS MANUFACTURED BY PHILIPS-RESPIRONICS, EVERFLO MODEL, SERIAL NUMBER (B)(6). THIS DEVICE IS NOT MANUFACTURED BY LNOGEN INC. REC'D CALL FROM (B)(6), DISCHARGE PLANNER AT (B)(6) HOSPITAL. PT ATTEMPTED TO LIGHT A CIGARETTE WHILE USING THE STATIONARY OXYGEN CONCENTRATOR WHICH RESULTED IN IGNITION OF THE OXYGEN AND BURNS TO THE FACE. PER HOSPITAL, PT IS OK AND BEING DISCHARGED TODAY. UNDER RECOMMENDATION OF MD, SHE IS BEING ADVISED TO USE HUMIDIFIER WITH HOME 02. NO DAMAGE TO EQUIPMENT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595472 EVERFLO GENERATOR, OXYGEN, PORTABLE CAW PHILIPS-RESPIRONICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown