MAUDE Adverse Event Report: INOGEN, INC. INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR

Model Number	IO-400
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Convulsion/Seizure (4406)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event is estimated.The unit came for oxygen error.No trouble found.Run the unit for 24 hours.The unit is working well and within specification.The data log shows battery low errors; this means patient running unit on low battery.Unit works fine with a good battery.
Event or Problem Description
It was reported that the patient's device had stopped providing oxygen.No alarms were noted.As a result, the patient had a grand mal seizure due to the lack of oxygen and was hospitalized.It was noted that the patient does have a seizure diagnosis prior to the event and is on medication.Patient had an alternative oxygen supply source at the time of the event, but was transferred to the hospital oxygen supply when arriving to the hospital.Patient noted that the seizures lasted approximately three to four minutes in duration.Patient's pulmonologist agreed that the event was caused due to the lack of oxygen.Patient received a replacement device and is doing fine.
Additional Manufacturer Narrative
Correction: section e initial reporter has been corrected from the initial report.

• Brand Name: INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ONE G4 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: 23537562
• Report Number: 3004672275-2025-00159
• Device Sequence Number: 21350716
• Product Code: CAW
• UDI-Device Identifier: 00817131020117
• UDI-Public: (01)00817131020117
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

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: IO-400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2025
• 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: Life Threatening; Hospitalization
• Patient Sex: Unknown