MAUDE Adverse Event Report: INOGEN INC INOGEN ONE G3

Model Number IO-300

Device Problems Device Stops Intermittently (1599); Fitting Problem (2183); Battery Problem (2885)

Patient Problem Hypoxia (1918)

Event Date 01/28/2016

Event Type  malfunction  

Event Description

I purchased an inogen one g3 portable oxygen concentrator and experienced the system occasionally stopping with no notice.When it stops working it is impossible to detect unless you are looking at it.I have idiopathic pulmonary fibrosis and my o2 blood count drops into the 70s within minutes.I informed the company and they told me to detach the battery and plug it back in.This re-boots the system.This works but the time passed before noticing the failure can be too lengthy.The company has replaced the system for me on four occasions but the new systems continued to fail.I am a retired aerospace electro-mechanical designer and have monitored and documented the failures.Inogen has two different batteries available for this system.One is an 8 cell battery good for about 4 hours on 2 ltr setting and the other is a 16 cell which is good for about 8 hours on the 2 ltr setting.I have not experienced any failures on the 8 cell batteries but 36 failures on the 16 cell batteries during the last 9 months.I informed the company as to my findings and informed them i would be happy to further test the 16 cell batteries but i would need a new one to rest.I would not buy one as they are (b)(6) each.I have two that i purchased and experienced failures on both.They implied that i didn't have the impossible because of the way the battery clips in.If you intentionally put it in part way, the slightest bump forces the spring clip to snap the battery all the way in.Plus after 36 failures i have become expert on the status.The bottom line is this system sporadically fails without warning which causes pts on oxygen 24/7 to go without until they notice the failure.Oxygen blood levels below 88 begin causing organ damage and possible failure.

• Brand Name: INOGEN ONE G3
• Type of Device: INOGEN ONE G3
• Manufacturer (Section D): INOGEN INC
• MDR Report Key: 5406497
• MDR Text Key: 37453628
• Report Number: MW5059938
• Device Sequence Number: 1
• Product Code: CAW
• 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: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IO-300
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 88