BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2942724 · Received February 4, 2013

    Report

    Report Number
    3004493922-2013-00236
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER DEALER ALARM IS NOT WORKING. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47278 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE SUZHOU IRC5LXO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other