MAUDE Adverse Event Report: INOGEN, INC. INOGEN ONE G5 OXYGEN CONCENTRATOR

Model Number	IO-500
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, the evaluation was not yet completed.The investigation is ongoing, and a supplemental report will be submitted if additional information is provided by the user facility.
Event or Problem Description
The customer reported to inogen, that the device displayed exhaust error.The device alarmed during the event.Reportedly, the customer spent overnight in the hospital wherein the customer received additional oxygen.In turn, the customer received a replacement device and is feeling better.

• Brand Name: INOGEN ONE G5 OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ONE G5 OXYGEN CONCENTRATOR
• Manufacturer (Section D): INOGEN, INC.; 600 shiloh rd.; plano TX 75074
• Manufacturer Contact: falon whitfield ; 600 shiloh rd.; plano, TX 75074 ; 9726165673
• MDR Report Key: 18491743
• Report Number: 3015238204-2024-00004
• Device Sequence Number: 3665493
• Product Code: CAW
• UDI-Device Identifier: 00817131020049
• UDI-Public: (01)00817131020049
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K032818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: IO-500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown