BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4190027 · Received October 21, 2014

    Report

    Report Number
    1031452-2014-15357
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Report Date
    October 1, 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

    PER PROVIDER, ALARMING WITH LOW O2. INDICATION IS THAT SIEVE BED FILTERS (BOTTOM) ARE NOT SEATED PROPERLY ALLOWING SIEVE MATERIAL TO BECOME PULVERIZED AND BYPASS FILTER. SIEVE DUST IS MIGRATING INTO THE MANIFOLD VALVE AND MUFFLER. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668669 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other