MAUDE Adverse Event Report: INOGEN, INC. INOGEN ROVE 4 PORTABLE OXYGEN CONCENTRATOR

Model Number	IO-401
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	04/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event is estimated.The unit received a reported oxygen error, which was confirmed through the data log shows 02 low.Internal low (46%) and external 02 reading servomex (74%).The issue was caused by contaminated zeolite, indicating that the zeolite absorbed excessive moisture.Filter frames are dirty due to dust.Lower housing mount damage due to compressor vibration.Housing replaced cosmetics issue.
Event or Problem Description
It was reported that when the patient was visited by a home healthcare service, the workers noted that the device was not producing enough oxygen as it should and the patient was also experiencing shortness of breath.As a result, the patient was sent to the hospital and received a backup concentrator.It was noted that the patient was hospitalized at the time due to an unrelated uti.Patient has since left the hospital and received a replacement device as well.

• Brand Name: INOGEN ROVE 4 PORTABLE OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ROVE 4 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: 25086664
• Report Number: 3004672275-2026-00120
• Device Sequence Number: 21434798
• Product Code: CAW
• UDI-Device Identifier: 00817131020414
• UDI-Public: (01)00817131020414
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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-401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2025
• 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
• Patient Sex: Unknown