MAUDE Adverse Event Report: INOGEN, INC INOGEN ONE G3; GENERATOR, OXYGEN, PORTABLE

Device Problem Product Quality Problem (1506)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/20/2021

Event Type  Injury  

Event Description

I require 4lpm of oxygen or 5 tanks of oxygen to visit my son for the day.They are highly flammable and heavy for elderly to transport.I recently received a inogen one portable with an 8 cell battery that only lasts for 90 minutes.(b)(6) will not supply a 16 cell battery which would give me 3 hours away from a plug.Inogen is much safer for elderly and less flammable, no long cords to trip over or to worry about dangers if dropped.Why can't we get safer options that our doctors prescribe.Oxygen tanks instead of batteries for inogen one.(b)(6) health care.Fda safety report id # (b)(4).

• Brand Name: INOGEN ONE G3
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): INOGEN, INC
• MDR Report Key: 13479840
• MDR Text Key: 285420984
• Report Number: MW5107275
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: LARGANINE; CPAP; DILTIAZEM; FLUOXETINE , (FOREARM ROLLATOR (NOT COVERED BY INSURANCE ). I HAVE GONE THROUGH 4 SINCE 2007.; GRAPE SEED EXTRACT; OXYGEN; SPURALINA
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White