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); Unexpected Shutdown (4019)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	08/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's device was getting hot and shutting off while going to the doctor.As a result, the patient experienced shortness of breath.No additional information is available at this time as multiple attempts to contact the patient were unsuccessful.
Additional Manufacturer Narrative
The inogen team attempted to contact the patient for further information three times with no response.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.

• 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: 50547752
• Report Number: 3004672275-2026-00278
• Device Sequence Number: 10311939
• Product Code: CAW
• UDI-Device Identifier: 00817131020179
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K032818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2020
• 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