BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFECTO2 V WITH SENSOR 9153650799

    MDR report key: 4324884 · Received December 12, 2014

    Report

    Report Number
    1031452-2014-22446
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Report Date
    November 19, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER INDEPENDENT REPAIR CENTER STATEMENT ALLEGED ALARMING AND THE KEY FAILURE IS THE SIEVE BEDS ARE DUSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810388 PERFECTO2 V WITH SENSOR 9153650799 GENERATOR, OXYGEN, PORTABLE CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other