BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3123225 · Received May 21, 2013

    Report

    Report Number
    3004493922-2013-01105
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH AN IRC5LX CONCENTRATOR THAT IS SHUTTING DOWN UNEXPECTEDLY. IT IS UNKNOWN IF THE UNIT ALARMS TO WARN THE USER TO SWITCH TO AN ALTERNATIVE SOURCE OF OXYGEN. THIS IS NOT A LIFE-SUSTAINING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224432 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE SUZHOU IRC5LX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other