BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4070885 · Received September 9, 2014

    Report

    Report Number
    1031452-2014-08611
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Report Date
    August 12, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER INDEPENDENT REPAIR CENTER STATEMENT THE UNIT HAS LOW O2 OR YELLOW LIGHT. THE KEY FAILURE WAS THE PE VALVE FOR THE SIEVE BEDS WAS DEFECTIVE. ADDITIONAL MALFUNCTIONS IN THE ZIP TIES FOR THE SIEVE BEDS NEEDED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555624 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC10LX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other