BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3950964 · Received July 22, 2014

    Report

    Report Number
    1031452-2014-04126
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 16, 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

    IT WAS REPORTED THAT THE XPO100B CONCENTRATOR IS ALARMING WITH ERROR CODE 3 AND 4 THEN SHUTS DOWN ABOUT A MINUTE AFTER STARTING UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428822 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS XPO100B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other