BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN ONE G5 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 12945690 · Received December 6, 2021

    Report

    Report Number
    3015238204-2021-00034
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    November 8, 2021
    Report Date
    December 6, 2021
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    UDI-DI
    00817131020162
    PMA / PMN Number
    K032818
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS INITIATED TO DETERMINE THE CAUSE OF THE MALFUNCTION. THE REASON FOR THE "LOW OXYGEN ERROR" WAS THAT ONE SIDE OF THE COLUMNS WAS LEAKING ZEOLITE FROM THE TOP. THIS WAS DUE TO ZEOLITE BREAKDOWN. ZEOLITE DUST IS CAUSED BY THE BREAKDOWN OF THE ZEOLITE PARTICLES. THIS OCCURS WHEN THE ZEOLITE RUBS AGAINST ONE ANOTHER. WHEN THE COLUMNS ARE NOT FILLED PROPERLY OR THE TENSION SPRING IS NOT UP TO SPECIFICATION, IT WILL CAUSE THE ZEOLITE TO RUB AND VIBRATE AGAINST EACH OTHER CAUSING THE DUST TO FORM. OVER TIME THIS CAN LEAD TO MULTIPLE ERRORS. THIS BREAKDOWN CAUSED THE LEVEL OF THE ZEOLITE RECEDE THUS, DIS-LODGING THE TOP FRIT FROM SEALING THE ZEOLITE IN THE COLUMN. THERE IS NO RISK OF FIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED A "LOW OXYGEN" ERROR MESSAGE. IN TURN THE DEVICE STOPPED OUTPUTTING OXYGEN. AS A RESULT, THE PATIENT VISITED THE EMERGENCY ROOM WHEREIN THEY RECEIVED OXYGEN. REPORTEDLY THE PATIENT IS FEELING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1843694 INOGEN ONE G5 PORTABLE OXYGEN CONCENTRATOR INOGEN ONE G5 PORTABLE OXYGEN CONCENTRATOR CAW INOGEN, INC. IO-500 00817131020162

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization