BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3911452 · Received July 3, 2014

    Report

    Report Number
    1031452-2014-02967
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 6, 2014
    Report Date
    June 2, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE (B)(4) CONCENTRATOR IS GIVING A 3 & 4 ERROR CODE AND THE CONCENTRATOR IS SHUTTING DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390105 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS XPO100B

    Patients

    Seq Age Sex Outcome Treatment
    1 73 Other