BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4040336 · Received August 27, 2014

    Report

    Report Number
    1031452-2014-07365
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Report Date
    August 1, 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 PROVIDER: UNIT IS ALARMING. PER INDEPENDENT REPAIR CENTER STATEMENT, THE UNIT WAS ALARMING OR RED LIGHT. THE KEY FAILURE IS MANIFOLD ASSY LEAKING. ADDITIONAL ISSUES ARE INLET FILTER DIRTY, ZIP TIE REPLACED AND HOSE CLAMP REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519969 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other