MAUDE Adverse Event Report: INOGEN, INC. INOGEN ONE G4 BLUETOOTH PORTABLE OXYGEN CONCENTRATOR

Model Number	IO-400
Medical Device Problem Codes	Overheating of Device (1437); Insufficient Flow or Under Infusion (2182); Noise, Audible (3273)
Health Effect - Clinical Codes	Dyspnea (1816); Low Oxygen Saturation (2477)
Date of Event	05/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's device was noisy, overheating, and not providing enough oxygen.Replacement columns did not resolve the issue.As a result, the patient's oxygen levels would drop and they would experience difficulty breathing.When the patient is home, they are able to go to their stationary unit; however, when the patient is at work traveling, they are unable to get access to a backup device.The patient mentioned they have been hospitalized previously due to this issue.A replacement device was sent out to the patient and the patient is doing better.
Additional Manufacturer Narrative
B3: date of event is estimated.As the device is not returned, no other information is available at this time to determine any other probable cause and/or the exact cause of the event.If the device is received an investigation will be conducted and a follow up will be submitted if required.

• Brand Name: INOGEN ONE G4 BLUETOOTH PORTABLE OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ONE G4 BLUETOOTH PORTABLE OXYGEN CONCENTRATOR
• Manufacturer (Section D): INOGEN, INC.; 600 shiloh rd; plano TX 75074
• Manufacturer (Section G): INOGEN, INC.; 600 shiloh rd; plano TX 75074
• Manufacturer Contact: greg porter ; 600 shiloh rd; plano, TX 75074
• MDR Report Key: 25446325
• Report Number: 3004672275-2026-00152
• Device Sequence Number: 5938911
• Product Code: CAW
• UDI-Device Identifier: 00817131020179
• UDI-Public: (01)00817131020179
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2026

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?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Supplement Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 07/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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: Life Threatening
• Patient Sex: Unknown