BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4001581 · Received August 12, 2014

    Report

    Report Number
    1031452-2014-05624
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Report Date
    July 7, 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

    Description of Event or Problem · 1

    DURING TESTING AND REPAIR AT THE INDEPENDENT REPAIR CENTER, THE IRC5PO2 CONCENTRATOR WAS REPORTED TO BE ALARMING (RED LIGHT). THIS WAS DUE TO A LOOSE GEAR CLAMP WHICH LED TO THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479903 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other