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

Model Number IO-300

Device Problem Premature Discharge of Battery (1057)

Patient Problem Low Oxygen Saturation (2477)

Event Date 05/10/2021

Event Type  Injury  

Manufacturer Narrative

Udi and expiration date will be submitted in follow-up report when discovered.An internal investigation was initiated to determine the cause of the malfunction.No conclusions can be made due to tampering /opening and disassembly of the unit.

Event Description

It was reported the patient experienced atrial fibrillation due to battery depletion.In turn, the patient visited the emergency room for supplemental oxygen.

• Brand Name: INOGEN ONE G3HF PORTABLE OXYGEN CONCENTRATOR
• Type of Device: INOGEN ONE G3HF PORTABLE OXYGEN CONCENTRATOR
• Manufacturer (Section D): INOGEN, INC.; 326 bollay dr.; goleta CA 93117
• MDR Report Key: 12509676
• MDR Text Key: 272577001
• Report Number: 3015238204-2021-00020
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• PMA/PMN Number: K032818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IO-300
• Device Catalogue Number: IO-300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Date Manufacturer Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization