MAUDE Adverse Event Report: INOGEN, INC. INOGEN ROVE 6 PORTABLE OXYGEN CONCENTRATOR

Model Number	IO-501
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	02/20/2026
Type of Reportable Event	Serious Injury
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 in for system error and couldn't confirm complaint.Run the unit 24 hours -no errors pop up or record on the diagnostic page.The unit is working well and within specification.
Event or Problem Description
It was reported that the patient's device was not producing enough oxygen during their mother's funeral.The device displayed an error code and the patient stated they were having difficulty breathing.No additional information is available at this time as multiple attempts to contact the patient were unsuccessful.

• 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: 24639818
• Report Number: 3004672275-2026-00047
• Device Sequence Number: 18582155
• Product Code: CAW
• UDI-Device Identifier: 00817131020513
• UDI-Public: (01)00817131020513
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K230052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2023
• 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