BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3910197 · Received July 2, 2014

    Report

    Report Number
    1031452-2014-02838
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IRC5PO2 CONCENTRATOR PILOT VALVE IS BAD CAUSING THE UNIT TO ALARM AND SHUT DOWN (OHMS ARE OVER 200).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386668 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other