BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2 9153646963

    MDR report key: 5396185 · Received January 28, 2016

    Report

    Report Number
    1031452-2016-00346
    Event Type
    Malfunction
    Date Received
    January 28, 2016
    Report Date
    January 19, 2016
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    JC (B)(6) 2016 THIS PRODUCT WAS EVALUATED AND REPAIRED BY AN INDEPENDENT REPAIR CENTER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    PER THE INDEPENDENT REPAIR CENTER, THE CUSTOMER ALLEGED PROBLEM IS THE UNIT ALARMS ARE NOT FUNCTIONAL. THE KEY FAILURE IS THE ON OFF SWITCH HAS NO AUDIBLE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54928 PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2 9153646963 GENERATOR, OXYGEN, PORTABLE CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1