MAUDE Adverse Event Report: Inogen, Inc. Inogen Rove 6 Portable Oxygen Concentrator

Model Number	IO-501
Medical Device Problem Codes	Premature Discharge of Battery (1057); Overheating of Device (1437); Unexpected Shutdown (4019)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	08/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's device was shutting off by itself and the battery was not lasting when they were outside of their home.The system hot error message was seen.As a result, the patient's oxygen levels decreased and they were taken to the hospital.No additional information is available at this time as multiple attempts to contact the patient were unsuccessful.
Additional Manufacturer Narrative
B3: date of event is estimated.The inogen team attempted to contact the patient for further information three times with no response.The unit came for system hot, and the complaint confirmed with data log and fan up and hitting accumulator probably due to dropped unit/high impact and that caused system heat.Reseat the fan fixed the issue.Column pressure is too high that caused by muffler and feed port assembly filled with dust and became blocked.

• Brand Name: Inogen Rove 6 Portable Oxygen Concentrator
• Common Device Name: Inogen Rove 6 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: 50486321
• Report Number: 3004672275-2026-00272
• Device Sequence Number: 21355585
• Product Code: CAW
• UDI-Device Identifier: 00817131020513
• UDI-Public: (01)00817131020513
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K230052
• 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): 08/27/2026

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-501
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/14/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2025
• 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; Hospitalization
• Patient Sex: Unknown