BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2 9153646963

    MDR report key: 4501541 · Received February 10, 2015

    Report

    Report Number
    1031452-2015-06627
    Event Type
    Malfunction
    Date Received
    February 10, 2015
    Report Date
    February 3, 2015
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER IS SWAPPING OUT ALL PILOT VALVES WITH NEW PART # 2003052 UNDER WARRANTY ALONG WITH O'RINGS. DEALER ALLEGES UNITS WHERE SHUTTING DOWN WITH TWO GREEN AND ONE RED ERROR CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94035 PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2 9153646963 GENERATOR, OXYGEN, PORTABLE CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other