BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4242239 · Received November 11, 2014

    Report

    Report Number
    1031452-2014-18267
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Report Date
    October 22, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER STATED THAT CONCENTRATOR IS REAL LOUD AND GIVING TWO GREEN LIGHTS, ONE RED LIGHT. THE DEALER ALSO STATED THAT THE UNIT IS GIVING LOW PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725610 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC10LXO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other