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	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's battery was not lasting as long with a full charge.As a result, the unit lost power and completely shut down causing the patient to have shortness of breath due to no oxygen from the unit.Troubleshooting did not resolve the issue, but it was determined that the battery needed to be replaced.A replacement battery was sent to the patient and it is working as intended for them.Because the battery is an accessory to the device, the unit is listed below, but the issue remains with the battery.
Additional Manufacturer Narrative
B3 date of event is estimated.The battery is considered as an accessory and was not returned for evaluation.

• 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: 50531547
• Report Number: 3004672275-2026-00276
• Device Sequence Number: 9910724
• Product Code: CAW
• UDI-Device Identifier: 00817131020414
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K222086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2026
• 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