BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4151256 · Received October 8, 2014

    Report

    Report Number
    3008262382-2014-01479
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 16, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    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

    PER INDEPENDENT REPAIR CENTER STATEMENT THE UNIT WAS ALARMING OR RED LIGHT. THE KEY FAILURE WAS THE 4 WAY VALVE NOT SHIFTING. ADDITIONAL MALFUNCTIONS INCLUDE THE LED PANEL WAS DAMAGED, AND THE HOSE CLAMPS WERE LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632544 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE REHABILITATION EQUIP IRC5P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other