BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4110912 · Received September 23, 2014

    Report

    Report Number
    1031452-2014-10560
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    August 29, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER REPAIR CENTER, UNIT CONTAMINATED / LOW O2.PER INDEPENDENT REPAIR CENTER STATEMENT, LOW O2 OR YELLOW LIGHT. THE KEY FAILURE WAS THAT THE MANIFOLD VALVE WAS CONTAMINATED. OTHER ISSUES WERE THAT THE SIEVE BEDS WERE CONTAMINATED AND THE MANIFOLD HOSE CLAMPS WERE DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592608 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other