MAUDE Adverse Event Report: Inogen, Inc. Inogen At Home Oxygen Concentrator

Model Number	GS-100
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	07/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's device was overheating and a system hot error message was seen.As a result, the patient stopped using the machine and had a "crisis on oxygen." a replacement device was sent to the patient.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.There is no confirmation for the return reason of system hot.All parameters are within specifications, and the unit is running well with no issues.

• Brand Name: Inogen At Home Oxygen Concentrator
• Common Device Name: Inogen At Home 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: 50309625
• Report Number: 3004672275-2026-00256
• Device Sequence Number: 10635344
• Product Code: CAW
• UDI-Device Identifier: 00817131020148
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

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: GS-100
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• 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: Other
• Patient Sex: Unknown