MAUDE Adverse Event Report: INOGEN INC. INOGEN ROVE 6 PORTABLE OXYGEN CONCENTRATOR

Model Number	IO-501
Medical Device Problem Codes	Smoking (1585); No Flow (2991)
Health Effect - Clinical Codes	Dyspnea (1816); Respiratory Insufficiency (4462)
Date of Event	12/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's unit started smelling like it was burning.The patient's son also reported that the patient had shortness of breath and they were not getting oxygen when the noticed the burning smell.They noticed that the unit had smoke coming out of the back of the unit.They did not have go to the hospital, but they did have a small tank of oxygen with them in the truck.They were house bound with their stationary unit until they received the replacement portable one which is working well for them at this time.
Additional Manufacturer Narrative
B3 date of event is estimated.The unit was returned for evaluation on 13-jan-2026.The unit received a complaint of a burning smell.The issue was confirmed, revealing burned power input.The power input failure was caused by overcurrent resulting from a low-voltage event.The power input was damaged due to wear and tear on the gold pad.During startup, the battery diagnostics page indicated high column pressure (3416), which was caused by the muffler and feed port assembly being filled with dust.The top housing showed signs of melting due to the power port burn.Data log indicated numerous battery-low errors, suggesting the unit was frequently operated on a low battery.

• Brand Name: INOGEN ROVE 6 PORTABLE OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ROVE 6 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: 24184742
• Report Number: 3004672275-2026-00018
• Device Sequence Number: 21336352
• Product Code: CAW
• UDI-Device Identifier: 00817131020513
• UDI-Public: (01)00817131020513
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230052
• 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
• Report Date (Section B): 01/26/2026

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: Lay User/Patient
• Device Model Number: IO-501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• 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
• Patient Sex: Unknown