BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3830927 · Received May 23, 2014

    Report

    Report Number
    1031452-2014-01702
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    April 10, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER PROVIDER THE UNIT HAS LOW PURITY AND HE IS NOT AWARE OF THE YELLOW LIGHT OR AN ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308002 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other