BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3821694 · Received May 20, 2014

    Report

    Report Number
    1031452-2014-01554
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    April 7, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IRC10LXO2 CONCENTRATOR WILL NOT POWER ON AT TIMES. UNIT DOES NOT ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300737 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC10LXO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other