BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 13027965 · Received December 17, 2021

    Report

    Report Number
    3015238204-2021-00036
    Event Type
    Death
    Date Received
    December 17, 2021
    Date of Event
    July 4, 2021
    Report Date
    January 19, 2022
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    UDI-DI
    00817131020179
    PMA / PMN Number
    K032818
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS INITIATED TO DETERMINE THE CAUSE OF THE MALFUNCTION. IT WAS DETERMINED THE NO POWER OUTPUT/INTERMITTENT POWER WAS DUE TO THE BATTERY BEING ALMOST EMPTY. FURTHER INVESTIGATION DISCOVERED THAT THE LEAF SPRINGS ON THE MOTHER-BOARD WERE BENT WHICH CAUSED THE BATTERY TO NON-FUNCTION.

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION CONCLUDED THE CAUSE OF THE MALFUNCTION. FURTHER INVESTIGATION IDENTIFIED THE "BENT LEAF SPRINGS" CAUSED THE POWER FROM THE AC OR DC POWER CORDS TO BE BLOCKED OR INCONSISTENT. HOWEVER, THE UNIT WOULD HAVE WORKED PROPERLY IF CONNECTED TO A CHARGED BATTERY. THE CAUSE OF THE BENT LEAF SPRINGS IS UNCLEAR BUT COULD HAVE RESULTED FROM THE UNIT BEING DROPPED. THE USER INSTRUCTIONS DO TELL THE USER TO CHECK THE BATTERY DISPLAY LIGHTS TO CONFIRM CHARGING STATUS, WHICH WOULD HAVE INFORMED THEM THAT THE BATTERIES WERE NOT CHARGED. FURTHER INVESTIGATION IDENTIFIED THE DEVICE FUNCTIONED AS INTENDED DURING THE QUALITY CONTROL CHECK PRIOR TO SHIPMENT TO THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    INOGEN INVESTIGATION IS STILL PENDING AND WILL FILE A SUPPLEMENTAL REPORT, IF NECESSARY, WHEN INVESTIGATION IS COMPLETED. INOGEN WILL WRITE A SUPPLEMENTAL FILING WITH ANY ADDITIONAL INFORMATION GATHERED.

    Description of Event or Problem · 0

    AFTER FURTHER ASSESSMENT, THEIR WAS NO LINKAGE BETWEEN THE DEATH OF THE PATIENT AND THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED BEING WITHOUT OXYGEN FOR A FIVE-HOUR FLIGHT. IN TURN, THE PATIENT WAS TAKEN TO THE HOSPITAL VIA AMBULANCE. AS A RESULT, THE PATIENT WAS ADMITTED TO THE ICU (B)(6) 2021. REPORTEDLY, THE PATIENT DIED THREE WEEKS LATER WHILE AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1929956 INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR CAW INOGEN, INC. IO-400 00817131020179

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| D