BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3884615 · Received June 19, 2014

    Report

    Report Number
    1031452-2014-02276
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    May 21, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE XPO100 CONCENTRATOR HAS 1,147 HOURS ON IT AND IS GETTING A 3 & 4 ERROR CODE. UNIT IS ALSO ALARMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361495 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS XPO100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other