BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3123105 · Received May 21, 2013

    Report

    Report Number
    1031452-2013-00939
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 25, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT THE CONCENTRATOR WAS SHUTTING DOWN UNEXPECTEDLY. IT IS UNKNOWN IF THE UNIT ALARMED AS DESIGNED TO ALERT THE USER TO SEEK AN ALTERNATE SOURCE OF OXYGEN PRIOR TO SHUTTING DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224955 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other