BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4101902 · Received September 19, 2014

    Report

    Report Number
    1031452-2014-10035
    Event Type
    Malfunction
    Date Received
    September 19, 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

    INDEPENDENT REPAIR CENTER: THE UNIT IS ALARMING OR HAS A RED LIGHT. THE PILOT VALVE IS LEAKING, THE O-RING IS DEFECTIVE, THE OUTLET BARB IS BROKEN, THE TIE WRAPS ARE DEFECTIVE, AND THE TIE STRAPS ARE DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582431 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other