MAUDE Adverse Event Report: INOGEN, INC. INOGEN AT HOME OXYGEN CONCENTRATOR

Model Number	GS-100
Medical Device Problem Codes	Overheating of Device (1437); Unexpected Shutdown (4019)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event is estimated.The inogen team attempted to contact the patient for further information three times with no response.A return of the device has been initiated.Once the device is received an investigation will be conducted and a follow up will be submitted if required.
Event or Problem Description
It was reported that the patient's device shutdown by itself.The system hot error message was prior.As a result, the patient was without oxygen for a couple of hours.No additional information is available at this time as multiple attempts to contact the patient were unsuccessful.

• 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: 24745141
• Report Number: 3004672275-2026-00068
• Device Sequence Number: 12970302
• Product Code: CAW
• UDI-Device Identifier: 00817131020148
• UDI-Public: (01)00817131020148
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K132489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2023
• 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