BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3183316 · Received June 21, 2013

    Report

    Report Number
    1031452-2013-01171
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 28, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MFR. REPORT # 1031452-2013-01171 INDICATING THE DATE OF THIS REPORT AS 05/27/2013 WHEN THE CORRECT DATE IS 05/28/2013.

    Description of Event or Problem · 1

    PROVIDER STATES SHUTS DOWN AFTER 40 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283867 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other