BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2 9153646963

    MDR report key: 4537965 · Received February 24, 2015

    Report

    Report Number
    1031452-2015-08846
    Event Type
    Malfunction
    Date Received
    February 24, 2015
    Report Date
    February 17, 2015
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER ALLEGES THE GFI POPS AND THE IRC5PO2 CONCENTRATOR ALARMS. THE DEALER STATED THE UNIT HAS 12992 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130719 PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2 9153646963 GENERATOR, OXYGEN, PORTABLE CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other