BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3143726 · Received June 3, 2013

    Report

    Report Number
    1031452-2013-01035
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT WAS NOT GIVEN TO REGULATORY AFFAIRS FOR PROCESSING UNTIL 05/31/2013.

    Description of Event or Problem · 1

    DEALER STATED THAT THE IRC5PO2 CONCENTRATOR IS NOT ALARMING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244127 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other