MAUDE Adverse Event Report: INOGEN, INC. INOGEN ONE G2 OXYGEN CONCENTRATOR; PORTABLE OXYGEN CONCENTRAOR

Model Number IO-200

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Burning Sensation (2146)

Event Date 02/16/2014

Event Type  Injury  

Event Description

As reported to inogen per client services representative: case manager with hospital facility called stating that a pt was admitted for burns to his face caused by smoking while on oxygen; pt was using inogen one portable oxygen unit via nasal cannula while smoking.

Manufacturer Narrative

Patient was operating oxygen concentrator device in direct violation of warning labels that are prominently located on the device itself and prominently included in the instructions for use: "no smoking", "no open flames".There is no indication of device malfunction contributing to adverse event.Warning labels use standard fda and internationally accepted symbols in addition to english language.

• Brand Name: INOGEN ONE G2 OXYGEN CONCENTRATOR
• Type of Device: PORTABLE OXYGEN CONCENTRAOR
• Manufacturer (Section D): INOGEN, INC.; 326 bollay drive; goleta CA 93117
• Manufacturer Contact: mara korsunsky ; 326 bollay drive; goleta, CA 93117 ; 8055620629
• MDR Report Key: 3732996
• MDR Text Key: 19570277
• Report Number: 3004672275-2014-00001
• Device Sequence Number: 1
• Product Code: CAW
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: IO-200
• Device Catalogue Number: IO-200
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2014
• Initial Date FDA Received: 03/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NON AWARE OF BY MANUFACTURER.
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR