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

Model Number	GS-100
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	06/28/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
On (b)(6) 2025, the patient called ingoen, to report that the yellow light appeared there was no oxygen output on his gs home concentrator.The paitent stated 911 was called and he was taken to the hospital but was not admitted.The inogen team attempted to contact patient for further information three times with no response.Intervention is unknown.

• Brand Name: INOGEN GS HOME OXYGEN CONCENTRATOR
• Common Device Name: INOGEN GS 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: 22567003
• Report Number: 3004672275-2025-00104
• Device Sequence Number: 9237456
• Product Code: CAW
• UDI-Device Identifier: 00817131020131
• UDI-Public: (01)00817131020131
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K032818
• 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): 07/22/2025

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: 06/28/2025
• Initial Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2021
• 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