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

Model Number	GS-100
Medical Device Problem Codes	No Flow (2991); Unexpected Shutdown (4019)
Health Effect - Clinical Codes	Cyanosis (1798); Low Oxygen Saturation (2477); Confusion/ Disorientation (2553)
Date of Event	11/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The unit was returned for evaluation on 25-nov-2025.The return reason of oxygen error is confirmed since zeolite dust existed in the unit, which was possibly caused by the breakdown of the zeolite particles.This occurs when the zeolite rubs against one another.Over time this can lead to multiple errors.This dust is so fine it can escape the column frits and contaminate the muffler with zeolite dust.
Event or Problem Description
It was reported that the patient's stationary unit stopped working.It was beeping and there was a fine white dust coming from the unit.As a result, the patient's oxygen saturation levels had dropped significantly causing their fingers to turn blue and causing them to feel disoriented.They were unable to access their backup portable unit, however the patient's son provided a backup oxygen source to ensure the patient got enough oxygen.The patient did not have to go the hospital nor did they have to contact emergency services.The patient has received a replacement unit and it is working well for them.

• 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: 23729298
• Report Number: 3004672275-2025-00176
• Device Sequence Number: 10615511
• Product Code: CAW
• UDI-Device Identifier: 00817131020148
• UDI-Public: (01)00817131020148
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/05/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2020
• 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: Other; Life Threatening
• Patient Sex: Unknown