BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3872153 · Received June 13, 2014

    Report

    Report Number
    3008262382-2014-00074
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    May 19, 2014
    Manufacturer
    INVACARE SUZHOU
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IRC5LXO2 CONCENTRATOR HAS A DEFECTIVE ON/OFF SWITCH AND UNIT IS NOT ALARMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349704 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE SUZHOU IRC5LXO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other