BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3935216 · Received July 15, 2014

    Report

    Report Number
    3008262382-2014-00287
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    June 10, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PER END USER UNIT SHUTS DOWN AND GETS 1 RED AND 2 GREEN ERROR CODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412660 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE REHABILITATION EQUIP IRC5LX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other