MAUDE Adverse Event Report: INOGEN INC. INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR

Model Number IS-400

Device Problem Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient has alleged that the inogen one g4 portable oxygen concentrator was charging on the table attached to the power supply plugged in directly to the wall when the patient awoke to the rug and a piece of paper on fire.The patient has not reported that death or serious injury has occurred within the complaint file.Inogen's engineering team completed the failure investigation report which indicates that there were external burn marks to the device and the external power supply but not any evidence of internal heat damage or burn marks within the device.Additionally, there is not any evidence that a device malfunction occurred.

• Brand Name: INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR
• Type of Device: INOGEN ONE G4
• 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: 8942539
• MDR Text Key: 155933239
• Report Number: 3015238204-2019-23456
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00817131020179
• UDI-Public: 0100817131020179
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IS-400
• Device Catalogue Number: IO-400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Date Manufacturer Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR