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

Model Number	IO-300
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the device is received, an investigation will be conducted and a follow up will be submitted if required.
Event or Problem Description
It was reported that the unit got too warm and a system hot error message displayed on the unit.The unit burned on the patient's stomach, the cannula came off the unit when they took out the battery, and the customer cut their chin.It was reported that the customer did not go to the hospital for these injuries.The inogen team attempted to contact patient for further information three times with no response.Intervention is unknown.

• 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 Contact: kevin ford ; 600 shiloh rd; plano, TX 75074
• MDR Report Key: 21528000
• Report Number: 3004672275-2025-00026
• Device Sequence Number: 9560438
• Product Code: CAW
• UDI-Device Identifier: 00817131020049
• UDI-Public: (01)00817131020049
• Combination Product (Y/N): N
• 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): 03/05/2025

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: 02/10/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization
• Patient Sex: Unknown