BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3967725 · Received July 30, 2014

    Report

    Report Number
    1031452-2014-04839
    Event Type
    Malfunction
    Date Received
    July 30, 2014
    Report Date
    June 17, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE REPAIR STATEMENT, THE UNIT WAS ALARMING OR RED LIGHT, AND THE NYLON TIE OF THE OXYGEN SENSOR WAS DISCONNECTED.

    Description of Event or Problem · 1

    NYLON TIES DISCONNECT PER DEALER. ALARMING OR RED LIGHT PER REPAIR DOCUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443120 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other