BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3910893 · Received July 2, 2014

    Report

    Report Number
    1031452-2014-02945
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Report Date
    May 30, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER STATES THAT HER OXYGEN CONCENTRATOR SHUT DOWN ON HER THROUGHOUT THE NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386988 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5LX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other