BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFECTO2 V WITH SENSOR 9153650799

    MDR report key: 4705257 · Received April 20, 2015

    Report

    Report Number
    1031452-2015-13390
    Event Type
    Malfunction
    Date Received
    April 20, 2015
    Report Date
    April 9, 2015
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER ALLEGED THAT THE UNIT IS VERY HOT TO THE TOUCH AND SMELLS AS THOUGH IT IS BURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261760 PERFECTO2 V WITH SENSOR 9153650799 GENERATOR, OXYGEN, PORTABLE CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other