BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 14366666 · Received May 11, 2022

    Report

    Report Number
    3015238204-2022-00051
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    April 12, 2022
    Report Date
    May 11, 2022
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    PMA / PMN Number
    K032818
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS INITIATED TO DETERMINE THE CAUSE OF THE MALFUNCTION. HOWEVER, INOGEN INC IS NOT THE MANUFACTURER OF THE BATTERY COMPONENT OF THE DEVICE. THEREFORE, INOGEN WILL WRITE A SUPPLEMENTAL FILING WITH ANY ADDITIONAL INFORMATION GATHERED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE THE PATIENT VISITED THE HOSPITAL, THE PATIENT'S BATTERY RAN OUT. IN TURN, MEDICAL PERSONNEL PROVIDED A BACK UP SOURCE OF OXYGEN TO NO AVAIL. REPORTEDLY, THE PATIENT SATS WERE AT 64. AS A RESULT, THE PATIENT WAS PUT ON OXYGEN AND MONITORED UNTIL HE GOT TO 90. LATER THE SAME DAY, THE PATIENT WAS PLACED IN THE CAR FOR THE DRIVE HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954684 INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR CAW INOGEN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Unknown Hospitalization