BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4130310 · Received September 30, 2014

    Report

    Report Number
    3008262382-2014-01369
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Report Date
    September 10, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    INDEPENDENT REPAIR CENTER: STICKING, ALARMING OR RED LIGHT. PER INDEPENDENT REPAIR STATEMENT THE UNIT WAS ALARMING OR RED LIGHT. KEY FAILURE WAS THE VALVE MANIFOLD WAS STICKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607264 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE REHABILITATION EQUIP IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other