BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2930979 · Received January 28, 2013

    Report

    Report Number
    1031452-2013-00156
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 26, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. END USER THINKS SHE CANNOT FEEL THE PRESSURE. MDR FILED.,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36824 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other