BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFECTO2 V WITH SENSOR 9153650799

    MDR report key: 4953402 · Received July 30, 2015

    Report

    Report Number
    1031452-2015-15166
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Report Date
    July 8, 2015
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. A FOLLOW UP WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    PER THE INDEPENDENT REPAIR CENTER, THE CUSTOMER ALLEGED PROBLEM IS ALARMING/RED LIGHT. THE KEY FAILURE IS THE SIEVE BEDS HAS A MASSIVE LEAK. AS STATED ON THE REPAIR STATEMENT ADDITIONAL MALFUNCTION ON THIS DEVICE: POWER SWITCH HAS NO ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497642 PERFECTO2 V WITH SENSOR 9153650799 GENERATOR, OXYGEN, PORTABLE CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other