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

Model Number	IO-400
Medical Device Problem Codes	No Audible Alarm (1019); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An internal investigation was initiated to determine the cause of the malfunction.The initial low o2 errors were caused by a leaking product manifold.Twelve days later the columns were removed and re-inserted.When the columns were put back in, they were not fully seated into the unit.This is how the columns became contaminated with moisture, reducing the amount of oxygen that could be made.
Event or Problem Description
It was reported that the patient's oxygen was depleting.In turn the patients alarm did not sound.As a result, the patient was admitted to the hospital.Reportedly, troubleshooting was tried to no avail.
Additional Manufacturer Narrative
Additonal information: b5 correction information: h6.
Event or Problem Description
Additional information revealed the adverse event was unrelated to the inogen device.

• Brand Name: INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR
• Manufacturer (Section D): INOGEN, INC.; 326 bollay dr.; goleta CA 93117
• Manufacturer (Section G): INOGEN, INC.; 600 shiloh rd.; plano TX 75074
• Manufacturer Contact: john anderson ; 600 shiloh rd.; plano, TX 75074 ; 8172623801
• MDR Report Key: 11792594
• Report Number: 3015238204-2021-00002
• Device Sequence Number: 16956360
• Product Code: CAW
• UDI-Device Identifier: 00817131020117
• UDI-Public: 00817131020117
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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: 04/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2017
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown