BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4112575 · Received September 24, 2014

    Report

    Report Number
    1031452-2014-10602
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 3, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES, YELLOW LIGHT COMES ON, THEN RED LIGHT, BEEPS CONSTANTLY, HE CAN HEAR FAN BLOWING INSIDE. IF LEFT RUNNING IT WILL SHUT DOWN. CUSTOMER REPORTS THAT THIS HAPPENS AFTER ABOUT A HALF HOUR. CUSTOMER STATES HE WILL SHUT UNIT DOWN AND TURN ON THEN IT WILL WORK AGAIN FOR ANOTHER HALF HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593156 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other