BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4110028 · Received September 23, 2014

    Report

    Report Number
    1031452-2014-10550
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    September 3, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THE UNIT SHUTS DOWN WITH A SINGLE BEEP. CUSTOMER DOES HAVE AN ALTERNATE SOURCE OF OXYGEN IN THE MEANTIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590537 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5LXO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other