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

Model Number	IO-501
Medical Device Problem Codes	Failure to Run on Battery (1466); No Flow (2991)
Health Effect - Clinical Codes	Dyspnea (1816); Low Oxygen Saturation (2477)
Date of Event	09/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's unit stopped working following a routine battery change.As a result, the patient's oxygen levels started to drop and they experienced shortness of breath.They were able to make it back home and use their stationary concentrator without further intervention.A replacement unit was sent to the patient and it is working for them.
Additional Manufacturer Narrative
B3: date of event is estimated.The unit was returned for evaluation on 16-sep-2026.Unit came in for oxygen error.Unit has no 02 errors.All numbers are within specification and there is no popped-up error on the data log, however, dirty inlet filter due to dust and lower housing mount damage due to compressor vibration.

• 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: 50927274
• Report Number: 3004672275-2026-00316
• Device Sequence Number: 16133691
• Product Code: CAW
• UDI-Device Identifier: 00817131020513
• UDI-Public: (01)00817131020513
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/28/2026

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: 09/16/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2023
• 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