MAUDE Adverse Event Report: INOGEN, INC INOGEN ONE G4

Model Number	IO-400
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Chronic Obstructive Pulmonary Disease (COPD) (2237)
Date of Event	01/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The replacement unit has since been received by the patient.
Event or Problem Description
The patient stated experiencing a device issue where no oxygen was being released from her unit.This led to severe shortness of breath and an oxygen saturation level of 75%.Emergency services were contacted, and the patient was hospitalized.After evaluation, she was admitted for five days.During her stay, she received oxygen therapy and medications.The reported issue was attributed to the g4 unit, which was replaced following a troubleshooting attempt involving a hard reset, though the problem persisted.The patient's daughter provided additional details.The patient uses oxygen 24/7 at a setting of 3 due to copd.During the event, the device emitted an audible alarm.Despite having a house unit as an alternative supply, the lack of oxygen from the portable device necessitated emergency intervention.

• Brand Name: INOGEN ONE G4
• Common Device Name: INOGEN ONE G4
• Manufacturer (Section D): INOGEN, INC; 600 shiloh rd; plano TX 75074
• Manufacturer Contact: kevin ford ; 600 shiloh rd; plano, TX 75074
• MDR Report Key: 21688217
• Report Number: 3004672275-2025-00005
• Device Sequence Number: 8730868
• Product Code: CAW
• UDI-Device Identifier: 00817131020117
• UDI-Public: (01)00817131020117
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K032818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: IO-400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown