MAUDE Adverse Event Report: INOGEN INC. INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR

Catalog Number IO-300

Device Problem Fire (1245)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 07/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient was smoking while using the inogen one g3 portable oxygen concentrator causing the reported fire.Inogen's engineering team completed the failure investigation report as attached within the emdr.It was found during the investigation that the inogen one g3 device was functional and did not have any evidence of internal heat damage indicating a device malfunction leading to the reported fire.It is noted in the failure investigation report that the inogen one g3 device had external burn marks and a strong cigarette odor.It should be noted that the fire department was dispatched to the patient's home and it is noted within the fire report that the patient reported smoking while on supplemental oxygen causing the incident.Inogen warms the patient against smoking while using the device within the user manual however, in the event of smoking while using the device, there is a potential risk fire which can result in serious injury or death.

• Brand Name: INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR
• Type of Device: INOGEN ONE G3
• Manufacturer (Section D): INOGEN INC.; 1225 commerce drive; richardson TX 75081
• Manufacturer Contact: mara korsunsky ; 326 bollay drive; goleta, CA 93117 ; 8055620629
• MDR Report Key: 8947843
• MDR Text Key: 156081383
• Report Number: 3015238204-2019-34567
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: IO-300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 93 YR