BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4001960 · Received August 12, 2014

    Report

    Report Number
    1031452-2014-05661
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Report Date
    July 7, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DURING TESTING AND REPAIR AT THE (B)(6), THE IRC5PO2V CONCENTRATOR IS ALARMING (RED LIGHT). THIS WAS DUE TO A CONTAMINATED PILOT VALVE WHICH LED TO THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478298 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other