BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2902265 · Received January 8, 2013

    Report

    Report Number
    1031452-2013-00049
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Report Date
    January 8, 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

    DEALER STATED THAT THE ALARM ON AN IRC5PO2 CONCENTRATOR IS NOT FUNCTIONING. THIS EVENT PREVENTS THE USER FROM BEING ALERTED TO ANY MALFUNCTION WHERE THEY NEED TO SWITCH TO ANOTHER SOURCE OF OXYGEN AND TO SEEK REPAIRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9656 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other