MAUDE Adverse Event Report: INOGEN, INC INOGEN ONE GS

Model Number	GS-100
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Chronic Obstructive Pulmonary Disease (COPD) (2237)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Follow-up communication with the patient and spouse are being conducted to confirm the event details and provide support.
Event or Problem Description
The patient experienced a critical event involving a home oxygen concentrator.The device reportedly stopped producing oxygen, prompting the patient's spouse to contact emergency medical services.The patient, who relies on continuous oxygen therapy due to chronic copd and other medical conditions, was transported to the emergency room with critically low oxygen levels.Upon arrival, her oxygen saturation was recorded at zero, leading to hospital admission.The spouse reported that the device could not function beyond level 2, particularly during nighttime usage at levels 2-3.Although audible alarms were noted, there were no visual alerts at the time of the incident.The patient utilized an alternative oxygen supply during the device malfunction.A replacement unit was dispatched within three days, though the patient remains hospitalized.

• Brand Name: INOGEN ONE GS
• Common Device Name: INOGEN ONE GS
• Manufacturer (Section D): INOGEN, INC; 600 shiloh rd; plano TX 75074
• Manufacturer (Section G): INOGEN,INC; 600 shiloh; plano TX 75074
• Manufacturer Contact: kevin ford ; 600 shiloh rd; plano, TX 75074
• MDR Report Key: 21688899
• Report Number: 3004672275-2024-00113
• Device Sequence Number: 15779926
• Product Code: CAW
• UDI-Device Identifier: 00817131020131
• UDI-Public: (01)00817131020131
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/01/2025

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: 12/02/2024
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2017
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown