BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3964051 · Received July 29, 2014

    Report

    Report Number
    1031452-2014-04606
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    June 4, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE (B)(4) CONCENTRATOR IS ALARMING. IT WAS DISCOVERED DURING REPAIR THAT THE SIEVE BEDS ARE LEAKING AND THE MANIFOLD VALVE IS CONTAMINATED. PER REPAIR STATEMENT UNIT IS ALARMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441816 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other