BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERFLO

    MDR report key: 17516417 · Received August 11, 2023

    Report

    Report Number
    MW5123366
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    April 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    PHILIPS-RESPIRONICS
    Product Code
    CAW
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PATIENT STATES SHE WAS SMOKING HER CIGARETTE WHILE USING HER HOME BASED OXYGEN UNIT AND A SPARK FLEW DOWN AND HIT THE OXYGEN TUBING. THIS SPARKED A FIRE. SHE WAS TAKEN TO THE HOSPITAL AND GIVEN TEMPORARY TANKS. HER HOUSE WAS PRETTY MUCH A COMPLETE LOSS IN ADDITION TO ALL OUR EQUIPMENT. THE STATIONARY OXYGEN CONCENTRATOR IS MANUFACTURED BY PHILIPS-RESPIRONICS, EVERFLO MODEL, SERIAL NUMBER (B)(6). THIS DEVICE IS NOT MANUFACTURED BY INOGEN INC. (B)(4). 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
    2117455 EVERFLO GENERATOR, OXYGEN, PORTABLE CAW PHILIPS-RESPIRONICS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Unknown