MAUDE Adverse Event Report: INOGEN, INC. INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR

Model Number	IO-400
Medical Device Problem Codes	Circuit Failure (1089); Overheating of Device (1437)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	06/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported by the patient that, while driving in the car to the doctor's office, her device allegedly started to smoke.Once she arrived to the office, she was placed on clinic-provided oxygen.An internal investigation was initiated to determine the cause of the malfunction.It was confirmed that the motherboard had malfunctioned, causing the device to overheat.The device functioned as intended and shut down to prevent further overheating.
Event or Problem Description
It was allegedly reported by the patient that their g4 battery would not take a charge and that the unit was getting hot.The patient swapped out the battery and used the unit in the car the following day while on the way to her doctor's office.It was reported that, when the unit was turned on, it allegedly began smoking.Once she arrived at the doctor's office, she was provided with oxygen and a wheelchair.

• Brand Name: INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ONE G4
• Manufacturer (Section D): INOGEN, INC.; 326 bollay dr; goleta, ca
• MDR Report Key: 10319775
• Report Number: 3015238204-2020-00003
• Device Sequence Number: 19697428
• Product Code: CAW
• UDI-Device Identifier: 00817131020117
• UDI-Public: 00817131020117
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2020

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-400
• Device Catalogue Number: IO-400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR