BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4211411 · Received October 29, 2014

    Report

    Report Number
    1031452-2014-16578
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    October 8, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    INDEPENDENT REPAIR CENTER CUSTOMER ALLEGED UNIT HAS LOW O2 OR YELLOW LIGHT AND THE KEY FAILURE IS THE ZIP TIES FOR THE PE VALVE ARE LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692868 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other