BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4131385 · Received October 1, 2014

    Report

    Report Number
    1031452-2014-11672
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 11, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    REPAIR CENTER ALLEGED - ALARMING / RED LIGHT. KEY FAILURE - SIEVE BED GASKET IS LEAKING.PER INDEPENDENT REPAIR STATEMENT UNIT ALARMING OR RED LIGHT. KEY FAILURE WAS THE SIEVE BED GASKET WAS LEAKING. ADDITIONAL MALFUNCTIONS WAS THE 4 WAY VALVE AND THE MUFFLER WAS CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611282 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other