MAUDE Adverse Event Report: INOGEN, INC. INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR

Model Number	IO-300
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	11/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event is estimated.Although this issue is attributed to the device's columns, this event will be reported on the oxygen concentrator unit.The unit was not returned for this issue.
Event or Problem Description
It was reported that the patient's device had overheated and received the replace columns message when they were leaving church.The patient happened to be in front of the er at the time of the event, so they went and stayed there for a couple of hours until they were released to their home.A replacement device was sent to the patient, no further information is available.The inogen team attempted to contact the patient for further information three times with no response.Although this issue is attributed to the device's columns, this event will be reported on the oxygen concentrator unit.

• Brand Name: INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ONE G3 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: 23822498
• Report Number: 3004672275-2025-00179
• Device Sequence Number: 10006150
• Product Code: CAW
• UDI-Device Identifier: 00817131020049
• UDI-Public: (01)00817131020049
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/16/2025

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-300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2022
• 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
• Patient Sex: Unknown