BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4093676 · Received September 16, 2014

    Report

    Report Number
    1031452-2014-09464
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 22, 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

    PER INDEPENDENT REPAIR CENTER STATEMENT THE (B)(4) CONCENTRATOR HAS LOW O2 OR YELLOW LIGHT. THE KEY FAILURE WAS THAT THE PE VALVE ASSEMBLY WAS LEAKING. OTHER ISSUES ADDRESSED WERE THE INLET FILTER WAS DIRTY, AND THE ZIP TIE ON THE PE VALVE NEEDED REPLACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572947 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other