BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3840329 · Received May 30, 2014

    Report

    Report Number
    3008262382-2014-00019
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 16, 2014
    Manufacturer
    INVACARE SUZHOU
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER ALLEGES THE UNIT SHUTS DOWN AND ALARMS RED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318164 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE SUZHOU IRC5P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other