BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2923496 · Received January 22, 2013

    Report

    Report Number
    1031452-2013-00114
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    January 18, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(6) ¿THE DEALER REPORTED THAT THE IRC5LXO2 CONCENTRATOR KEPT ON LOGGING OFF WITHOUT COMMAND. IT IS NOT KNOWN IF THE UNIT ALARMED AS DESIGNED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30186 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5LXO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other