BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4240629 · Received November 10, 2014

    Report

    Report Number
    1031452-2014-18205
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 21, 2014
    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

    THE PROVIDED STATED THE PLASTIC UNDER THE COMPRESSOR COIL IS MELTED AND HE STATES THE PLASTIC HAS MELTED ALL THE WAY BACK TO THE COMPRESSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723828 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IOH200PV65P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other