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

Model Number	IO-300
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Fall (1848)
Date of Event	04/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event is estimated.The inogen team attempted to contact the patient for further information three times with no response.There is no confirmation for the return reason of system hot.Zeolite is found contaminated which possibly caused when it absorbs the moisture.
Event or Problem Description
It was reported that the patient fell getting out of their truck with the device.Troubleshooting displayed the system hot error message.It was noted that the patient was hospitalized.A replacement device was sent to the patient.No additional information is available at this time as multiple attempts to contact the patient were unsuccessful.

• Brand Name: INOGEN ONE G3 HIGH FLOW PORTABLE OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ONE G3 HIGH FLOW 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: 25176124
• Report Number: 3004672275-2026-00129
• Device Sequence Number: 18692005
• Product Code: CAW
• UDI-Device Identifier: 00817131020063
• UDI-Public: (01)00817131020063
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 05/14/2026

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: Health Professional
• Device Model Number: IO-300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2021
• 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