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

Model Number	GS-100
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Codes	Dyspnea (1816); Chronic Obstructive Pulmonary Disease (COPD) (2237)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On(b)(6) 2025, the patient called inogen to report that she could not pull the old columns out to replace them on the (gs), and that she had been hospitalize due to her oxygen levels dropping.The patient confirmed receiving oxygen at the hospital and is currently back home recovering.
Additional Manufacturer Narrative
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.

• Brand Name: INOGEN ONE GS HIGH FLOW PORTABLE OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ONE GS 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: 22320549
• Report Number: 3004672275-2025-00074
• Device Sequence Number: 21081854
• Product Code: CAW
• UDI-Device Identifier: 00817131020148
• UDI-Public: (01)00817131020148
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/24/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2019
• 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