BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4013019 · Received August 15, 2014

    Report

    Report Number
    1031452-2014-06244
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Report Date
    July 18, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER FAX, POWER SWITCH IS OPEN. PER INDEPENDENT REPAIR CENTER STATEMENT, UNIT WILL NOT START. THE KEY FAILURE WAS THE ON/OFF SWITCH FOR THE COMPONENTS PILOT VALVE WAS OPEN. ADDITIONAL MALFUNCTIONS WERE THE CASTER FOR THE BASE WAS MISSING, THE FITTING RECEPTACLE FOR THE BASE WAS MISSING AND THE SMALL CLAMP WAS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489718 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other