BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3230121 · Received July 16, 2013

    Report

    Report Number
    1031452-2013-01387
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    June 25, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY NO ALARMS SOUNDING. A NEW ALARM IS MAKING A VERY WEAK NOISE IN UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329969 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other