MAUDE Adverse Event Report: INOGEN, INC. INOGEN ONE GS PORTABLE OXYGEN CONCENTRATOR

Model Number	GS-100
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The unit was received for investigation on june 09, 2025.The unit was received with a reported system hot, which was confirmed through data log analysis.The compressor had low flow, which possibly caused due to damaged piston seals.Zeolite dust was observed in the unit which, is caused by the breakdown of the zeolite particles.That occurs when the zeolite rubs against one another.Over time this can lead to multiple errors.However, due to the mention of a fire hazard in the reported message and no further conclusions can be drawn without the patient's additional information.This complaint is being submitted in an abundance of caution.
Event or Problem Description
On (b)(6) 2025, the patient contacted inogen, to report that an error message indicating a potential fire hazard appeared on their gs home concentrator.The patient did not provide specific details regarding the circumstances of the message, including when or how it occurred.Inogen, attempted to follow up with the patient on three separate occasions to gather more information, but the patient was unreachable.No injuries, fires, or property damage were reported.This complaint is being submitted due to the nature of the error message referencing a potential fire hazard.

• Brand Name: INOGEN ONE GS PORTABLE OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ONE GS 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: 22243197
• Report Number: 3004672275-2025-00086
• Device Sequence Number: 21092827
• 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
• Type of Report: Initial
• Report Date (Section B): 06/17/2025

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: 06/09/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2020
• 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: Hospitalization
• Patient Sex: Unknown