BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4098383 · Received September 18, 2014

    Report

    Report Number
    1525712-2014-05987
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Report Date
    August 27, 2014
    Manufacturer
    UNKNOWN
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER DEALER, THE UNIT IS GETTING A 1R, 2GR ERROR. PILOT VALVE AND READ 198 TO HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578647 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other