BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3203396 · Received July 2, 2013

    Report

    Report Number
    1031452-2013-01254
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 10, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE PROVIDER STATED THE UNIT HAS LOW O2 AND WILL NOT ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301179 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other