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	Low Oxygen Saturation (2477)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was having issues with their device.As a result, their oxygen levels had decreased.The patient did not have a backup device at the time of the event.The patient was hospitalized for 3 weeks and had 3 weeks of rehab.The patient has received their replacement device and does not have any ongoing complications due to the event.
Additional Manufacturer Narrative
B3: date of event is estimated.The unit was received with a reported oxygen error, confirmed with the contaminated zeolite.Incoming internal 02 measured 89.6% and external 02 measured 89.1 %, both below specification.Furthermore, the psa cycle (according to the data log) being high (9) is an indication that the zeolite is getting contaminated by moisture.Also damaged compressor mounts 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: 50045243
• Report Number: 3004672275-2026-00215
• Device Sequence Number: 21236877
• Product Code: CAW
• UDI-Device Identifier: 00817131020513
• UDI-Public: (01)00817131020513
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K230052
• 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): 07/27/2026

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: 07/22/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2025
• 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: Hospitalization; Life Threatening
• Patient Sex: Unknown