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 Codes	Dyspnea (1816); Low Oxygen Saturation (2477)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's unit was displaying a replace columns message and it was not outputting enough oxygen.As a result, the patient had a hard time breathing.A replacement unit was sent to the patient.The inogen team attempted to contact the patient for further information three times with no response.
Additional Manufacturer Narrative
B3 date of event is estimated.The unit was returned for evaluation on 31-aug-2026.The unit was received with a reported oxygen error, confirmed with the contaminated zeolite.Incoming internal 02 measured 72.5% and external 02 measured 72.8%, both below specification.The issue was identified as high psa (15) caused by zeolite contamination from moisture absorption.Also mount plate damaged due to compressor vibration.The uip & lower housing was replaced due to damaged.

• 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: 50793977
• Report Number: 3004672275-2026-00292
• Device Sequence Number: 21464987
• Product Code: CAW
• UDI-Device Identifier: 00817131020414
• UDI-Public: (01)00817131020414
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/16/2026

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?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2026
• 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