BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3143730 · Received June 3, 2013

    Report

    Report Number
    1031452-2013-01037
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    February 27, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVACARE AWARENESS DATE 02/27/2013. COMPLAINT WAS NOT GIVEN TO REGULATORY AFFAIRS FOR PROCESSING UNTIL 05/24/2013.

    Description of Event or Problem · 1

    DEALER STATED THE IRC10LXO2 CONCENTRATOR IS NOT ALARMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245394 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC10LXO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other