BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3062277 · Received April 16, 2013

    Report

    Report Number
    3004493922-2013-00829
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT THE CONCENTRATOR SHUTS DOWN UNEXPECTEDLY. IT IS UNKNOWN IF THE UNIT ALARMED PRIOR TO TURNING OFF TO ALERT THE USER TO SWITCH TO AN ALTERNATE SOURCE OF OXYGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162383 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE SUZHOU IRC5P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other