BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3973381 · Received August 1, 2014

    Report

    Report Number
    1031452-2014-05090
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POPPET VALVE IS NOT SHIFTING (4 WAY) ON THE IRC5LXO2 CONCENTRATOR. REPAIR STATEMENT: ALARMING OR RED LIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451114 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5LXO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other