MAUDE Adverse Event Report: Inogen, Inc. Inogen One G3 High Flow Portable Oxygen Concentrator

Model Number	IO-300
Medical Device Problem Codes	Device Emits Odor (1425); Overheating of Device (1437)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's device was overheating and a burning smell was noted.The patient stated they were hospitalized due to the event.A replacement device was sent.No additional information is available at this time as attempt to follow-up with the patient for more information was unsuccessful.
Additional Manufacturer Narrative
B3: date of event is estimated.The inogen team attempted to contact the patient for further information, but the patient declined.There is no confirmation for the return reason of system hot.Zeolite is found contaminated which possibly caused when it absorbs the moisture.

• Brand Name: Inogen One G3 High Flow Portable Oxygen Concentrator
• Common Device Name: Inogen One G3 High Flow 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: 50117518
• Report Number: 3004672275-2026-00229
• Device Sequence Number: 15971923
• Product Code: CAW
• UDI-Device Identifier: 00817131020063
• UDI-Public: (01)00817131020063
• 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
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

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-300
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/24/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2021
• 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