MAUDE Adverse Event Report: INOGEN, INC. INOGEN ROVE 4 PORTABLE OXYGEN CONCENTRATOR

Model Number	IO-401
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Codes	Dyspnea (1816); Low Oxygen Saturation (2477)
Date of Event	03/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the device is not returned, no other information is available at this time to determine any other probable cause and/or the exact cause of the event.
Event or Problem Description
It was reported that the patient's oxygen levels dropped and they started having difficulty breathing when they were out for a walk.It was noted that the device was displaying the system error message and that the battery suddenly completely depleted.As a result, ems was called and they provided the patient with oxygen.Patient was taken to their car where they had had their spare battery.The patient is now doing fine.

• Brand Name: INOGEN ROVE 4 PORTABLE OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ROVE 4 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: 24897491
• Report Number: 3004672275-2026-00097
• Device Sequence Number: 21034131
• Product Code: CAW
• UDI-Device Identifier: 00817131020414
• UDI-Public: (01)00817131020414
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K222086
• 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): 04/16/2026

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-401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2025
• 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