MAUDE Adverse Event Report: Inogen, Inc. Inogen Rove 4 Portable Oxygen Concentrator

Model Number	IO-401
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	07/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's device was displaying the system error message and was not providing enough oxygen.As a result, the patient experienced shortness of breath.The patient did not have a backup at the time of the event.The patient has since received their replacement device and is doing well.
Additional Manufacturer Narrative
The unit was received with a reported system error, which was confirmed during testing.The unit shut down after a few minutes due to the compressor failure.Because compressor harness was damaged.Furthermore, the psa cycle (according to the data log) being high (14) is an indication that the zeolite is getting contaminated by moisture.Uip replaced due to cosmetic damage.

• 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: 50216564
• Report Number: 3004672275-2026-00245
• Device Sequence Number: 6099695
• Product Code: CAW
• UDI-Device Identifier: 00817131020414
• UDI-Public: (01)00817131020414
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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?: Yes
• Date Returned to Manufacturer: 07/31/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• 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