MAUDE Adverse Event Report: INOGEN, INC. INOGEN G4OXYGEN CONCENTRATOR; INOGEN G4 OXYGEN CONCENTRATOR

Model Number	IO-400
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	07/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The unit was received for investigation on july 22, 2025.The unit was brought in with a complaint of a burning smell, which was confirmed upon inspection.The motherboard (j13 & j1b) and the power inputwere found to be burnt.The motherboard damage was caused by an overcurrent and low voltage event, which subsequently led to the burning of the power input.Additionally, the unit's housing was observed to be dirty and cracked, likely resulting from rough cleaning and signs of user abuse.The patient received a replacement unit.
Event or Problem Description
On (b)(6) 2025 the patient called inogen to report that smoke was coming out of the their g4 device.Patient stated they tried to charge it again but burning smell kept coming out of the device.There was no patient harm or injury reported.This report is being submitted due to the nature of the patient claiming the device charging port was scorched.

• Brand Name: INOGEN G4OXYGEN CONCENTRATOR
• Common Device Name: INOGEN G4 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: 22669503
• Report Number: 3004672275-2025-00107
• Device Sequence Number: 19789487
• Product Code: CAW
• UDI-Device Identifier: 00817131020117
• UDI-Public: (01)00817131020117
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 07/30/2025

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-400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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