MAUDE Adverse Event Report: INOGEN, INC. NOGEN ONE G3HF OXYGEN CONCENTRATOR

Model Number IO-300

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Low Oxygen Saturation (2477)

Event Date 12/07/2023

Event Type  malfunction  

Event Description

The customer reported to inogen, that their unit kept shutting down while in dialysis.In turn, the patient was hospitalized and it was unknown for the duration.As a result, the customer was treated for more oxygen and is stable.

Manufacturer Narrative

An internal investigation was initiated to determine the cause of the malfunction.The device was not returned to inogen for evaluation.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

• Brand Name: NOGEN ONE G3HF OXYGEN CONCENTRATOR
• Type of Device: NOGEN ONE G3HF 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: 18536729
• MDR Text Key: 333212507
• Report Number: 3015238204-2024-00007
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00817131020063
• UDI-Public: (01)00817131020063
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IO-300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other