MAUDE Adverse Event Report: INOGEN, INC. INOGENG3 OXYGEN CONCENTRATOR; INOGEN G3 OXYGEN CONCENTRATOR

Model Number	IO-300
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On july 18, 2025, the patient contacted inogen, to report smoke and getting burn upon plugging in their g3 device.The patient did not provide specific details regarding the circumstances of 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 fires, or property damage were reported.Intervention is unknown.This complaint is being submitted due to the nature of patient claiming they had gotten burnt and referencing a potential fire hazard.
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: INOGENG3 OXYGEN CONCENTRATOR
• Common Device Name: INOGEN G3 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: 22798410
• Report Number: 3004672275-2025-00122
• Device Sequence Number: 20911553
• Product Code: CAW
• UDI-Device Identifier: 00817131020049
• UDI-Public: (01)00817131020049
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 08/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: IO-300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2018
• 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
• Patient Sex: Unknown