BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4100927 · Received September 19, 2014

    Report

    Report Number
    1031452-2014-10050
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 26, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    INDEPENDENT REPAIR CENTER: SIEVE IS SATURATED. PER INDEPENDENT REPAIR CENTER STATEMENT, THE UNIT WAS ALARMING OR RED LIGHT. THE KEY FAILURE WAS SIEVE IS SATURATED. ADDITIONAL MALFUNCTIONS WERE ZIP TIES LEAKS, POWER SWITCH ALARM DOESN'T FUNCTION, PM KIT DIRTY, 4 WAY VALVE NOT SHIFTING AND HOSE CLAMPS LEAKS, AND PVC TORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584176 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other