BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFECTO2 V WITH SENSOR 9153650799

    MDR report key: 4842783 · Received June 13, 2015

    Report

    Report Number
    1031452-2015-14310
    Event Type
    Malfunction
    Date Received
    June 13, 2015
    Report Date
    May 20, 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

    Additional Manufacturer Narrative · 1

    NO END USER INFORMATION PROVIDED. THE 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 ALARMING/RED LIGHT. THE KEY FAILURE IS THE 4-WAY VALVE IS NOT SHIFTING PROPERLY. ADDITIONAL MALFUNCTION IS POWER SWITCH, NO ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386708 PERFECTO2 V WITH SENSOR 9153650799 GENERATOR, OXYGEN, PORTABLE CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other