BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2 9153646963

    MDR report key: 4353088 · Received December 22, 2014

    Report

    Report Number
    1031452-2014-20098
    Event Type
    Malfunction
    Date Received
    December 22, 2014
    Report Date
    November 5, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER STATES THE UNIT HAS LOW O2. HE ALSO STATES THIS WILL BE THE 3RD TIME HE HAS SENT THIS UNIT IN FOR REPAIR. THE FIRST TIME WAS ON RA #(B)(4), IT WAS ALARMING AND SHUTTING DOWN. THEY REPLACED THE PILOT VALVE. THE 2ND TIME WAS RA #(B)(4) FOR LOW O2. THEY REPLACED THE 4-WAY VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842382 PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2 9153646963 GENERATOR, OXYGEN, PORTABLE CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other