MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Model Number 1020014

Device Problems Fire (1245); Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Date 12/13/2013

Event Type  Injury  

Event Description

The manufacturer received info alleging a pt was smoking while using an evenflo oxygen concentrator, and the unit caught on fire.The pt received burns to his face and was admitted to the hospital.

Manufacturer Narrative

The device was evaluated by the manufacturer's service center.The manufacturer determined the fire originated external to the device.During the device evaluation, the manufacturer observed that the device had a nicotine odor.The manufacturer reviewed the user manual for the everflo device.Product labeling states, "oxygen vigorously accelerates combustion and should be kept away from heat or open flame." product labeling also states, "do not smoke, allow others to smoke or have open flames near the concentrator when it is in use.".

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; kennesaw GA
• Manufacturer Contact: don mcandrews ; 1740 golden mile highway; monroeville, PA 15146 ; 7243873965
• MDR Report Key: 3592970
• MDR Text Key: 4142873
• Report Number: 1040777-2014-00004
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/19/2013

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: 1020014
• Device Catalogue Number: 1020014
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/04/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2013
• Initial Date FDA Received: 01/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR