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

Model Number	IO-401
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's device displayed a system error message and stopped providing oxygen to the patient while out at the market.As a result, the patient was unable to breathe and had to go back to their car.The patient did have a backup oxygen tank, but it was empty.A replacement device was sent to the patient.
Additional Manufacturer Narrative
The unit was received with a reported system error, confirmed with the contaminated zeolite.Incoming internal 02 measured 83.1 % and external 02 measured 77.8%, both below specification.The issue was identified as high psa (15) caused by zeolite contamination from moisture absorption.The uip was also 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: 50181289
• Report Number: 3004672275-2026-00239
• Device Sequence Number: 8270625
• Product Code: CAW
• UDI-Device Identifier: 00817131020414
• UDI-Public: (01)00817131020414
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: 07/30/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2025
• 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