BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3100732 · Received May 8, 2013

    Report

    Report Number
    3004493922-2013-01020
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Report Date
    April 12, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT THE CONCENTRATOR DOES NOT ALARM. THIS ISSUE WOULD NOT ALERT THE USER TO SWITCH TO AN ALTERNATE SOURCE OF OXYGEN AND TO SEEK REPAIRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200500 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE SUZHOU IRC5P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other