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

Model Number	IO-501
Medical Device Problem Codes	Overheating of Device (1437); No Flow (2991); Unexpected Shutdown (4019)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	06/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 date of event is estimated.The unit was returned for evaluation on 29-jun-2026.The unit was returned with noisy complaint, which was confirmed during testing.The issue was traced to damaged compressor mount due to compressor vibration.Additionally, high pressure caused by the muffler being filled with dust, which resulted in a blockage in the feed port and low sieve life (205).Furthermore, the psa cycle being high (16) is an indication the zeolite is getting contaminated by moisture and leak from cannula receptacle due to the high impact to the unit.Ulp, & lower housing were also replaced due to cosmetic damage.
Event or Problem Description
It was reported that the patient's unit had an error message and was overheating causing a loud noise.In turn, the unit suddenly shutdown leading to no oxygen causing the patient to have shortness of breath.This happened while they were in a car and they had to go back home, where they were able to use their stationary concentrator to get oxygen again.A replacement unit was sent to the patient and it is working for them.

• 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: 25748635
• Report Number: 3004672275-2026-00196
• Device Sequence Number: 10242698
• Product Code: CAW
• UDI-Device Identifier: 00817131020513
• UDI-Public: (01)00817131020513
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 07/08/2026

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: 06/29/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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