BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2970591 · Received February 20, 2013

    Report

    Report Number
    1031452-2013-00351
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Report Date
    February 20, 2013
    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

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. CONSUMER ALLEGES CAR CHARGER SHUTS DOWN, ITEM NUMBER TOP130. THE DEVICE IS A SOLO2 CONCENTRATOR. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74390 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS SOLO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other