BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3130180 · Received May 24, 2013

    Report

    Report Number
    1031452-2013-00999
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 PRIOR TO SHUTTING DOWN 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
    232071 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS TPO100B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other