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 Codes	Low Oxygen Saturation (2477); Presyncope (4410)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device was not giving the patient enough oxygen while going on a walk.The system error message was seen.As a result, the patient's oxygen levels dropped and the patient almost fainted, going down on their knees.Patient then went back home and got back on their stationary device where they stabilized.Patient has since received their replacement device and is doing fine.
Additional Manufacturer Narrative
B3: date of event is estimated.The unit was returned with a system error complaint, which was confirmed during testing.The motherboard j20 component is burnt, and the power input was damaged, both consistent with an over current due to low voltage.The muffler was filled with dust, which resulted in a blockage in the feed port and damaged compressor mount due to compressor vibration.Leaking accumulator also sustained damage from the high impact.Furthermore, the psa cycle (according to the data log) being high (12) is an indication the zeolite is getting contaminated by moisture.Additionally, the fan was misaligned and contacting the accumulator likely due to high-impact incident, possibly from the unit being dropped.The uip, top housing & lower housing were also replaced due to cosmetic damage.

• 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: 24748014
• Report Number: 3004672275-2026-00069
• Device Sequence Number: 9318904
• Product Code: CAW
• UDI-Device Identifier: 00817131020513
• UDI-Public: (01)00817131020513
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: 03/11/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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