BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4130337 · Received September 30, 2014

    Report

    Report Number
    1031452-2014-11637
    Event Type
    Malfunction
    Date Received
    September 30, 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 ALLEGES THE IRC5PO2 CONCENTRATOR IS ALARMING / RED LIGHT KEY FAILURE - VALVE IS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608265 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other