BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2874735 · Received December 15, 2012

    Report

    Report Number
    1031452-2012-00429
    Event Type
    Malfunction
    Date Received
    December 15, 2012
    Report Date
    December 15, 2012
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE OXYGEN CONCENTRATOR HAD STOPPED WORKING. A TECHNICIAN WAS SENT OUT AND WHILE WORKING ON THE CONCENTRATOR A BLACK TONER LIKE SUBSTANCE WAS NOTICED BY THE END USER ON HER THE CARPET. THE TECH STOPPED WORKING ON THE UNIT. THERE IS NO INFORMATION OF INJURY OR ILL EFFECT TO THE END USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other