BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2923600 · Received January 22, 2013

    Report

    Report Number
    1525712-2013-00532
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 20, 2013
    Manufacturer
    UNKNOWN
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT THE IRC5PO2 CONCENTRATOR IS NOT ALARMING, AS DESIGNED, TO ALERT USER TO SWITCH TO AN ALTERNATE SOURCE OF OXYGEN AND TO SEEK REPAIRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29555 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW UNKNOWN IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other