BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3970286 · Received July 31, 2014

    Report

    Report Number
    1031452-2014-04808
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    June 13, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING AND REPAIR AT THE SERVICE CENTER THE DEVICE DISPLAYED A RED LIGHT VISUAL ALARM. THIS WAS DUE TO THE BROKEN REGULATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REGULATOR WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447942 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other