BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3110088 · Received May 13, 2013

    Report

    Report Number
    1031452-2013-00889
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Report Date
    April 17, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    NO INJURY OR MEDICAL INTERVENTION ALLEGED. THE DEALER STATED THAT THE IRC5LX CONCENTRATOR ALLEGEDLY CAUGHT FIRE CAUSING THE TUBING TO BURN. THE USER IS ALLEGEDLY A SMOKER AND HAS THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210090 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 BTI INVACARE FLORIDA OPERATIONS IRC5LX

    Patients

    Seq Age Sex Outcome Treatment
    1 60 Other