BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3955219 · Received July 24, 2014

    Report

    Report Number
    1031452-2014-04089
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    June 13, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPAIR STATEMENT, THE DEVICE A YELLOW LIGHT ALARM. THIS WAS DUE TO THE FOUR WAY VALVE BEING DEFECTIVE.

    Description of Event or Problem · 1

    PER THE REPAIR STATEMENT, THE DEVICE DISPLAYED A YELLOW LIGHT ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434504 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other