BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFECTO2 V WITH SENSOR 9153650799

    MDR report key: 4792350 · Received May 22, 2015

    Report

    Report Number
    1031452-2015-13869
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Report Date
    May 4, 2015
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER STATES THAT THE DEVICE IS ALARMING WITH THE 2 GREEN 1 RED HIGH PRESSURE NO SWITCHING ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337128 PERFECTO2 V WITH SENSOR 9153650799 GENERATOR, OXYGEN, PORTABLE CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other