BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3974815 · Received August 4, 2014

    Report

    Report Number
    1525712-2014-04243
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Report Date
    June 30, 2014
    Manufacturer
    UNKNOWN
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER ALLEGED THAT THE UNIT IS NOT ALARMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453426 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW UNKNOWN CONCENTPULSE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other