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

Model Number	IO-401
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Noise, Audible (3273)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	04/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's unit had an error message and made a loud noise.As a result, the unit was not producing enough oxygen and caused the patient to panic.The patient had to stay and do breathing exercises for several hours to calm down as they did not have any backup sources with them.There were no other interventions at the time.The patient has received the replacement unit and it is working.
Additional Manufacturer Narrative
B3 date of event is estimated.The unit was returned for evaluation on 29-apr-2026.The unit came in for service needed.The complaint confirmed.The data shows multiple 02 delivery errors that are caused by feed waste, probably dropped units.Column sieve life (0) that caused by zeolite contaminated too much absorbed moisture.Lower housing broken possibly dropped unit.

• 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: 25184547
• Report Number: 3004672275-2026-00133
• Device Sequence Number: 16026173
• Product Code: CAW
• UDI-Device Identifier: 00817131020414
• UDI-Public: (01)00817131020414
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

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: 04/29/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2024
• 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: Other
• Patient Sex: Unknown