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

Model Number 1020010

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

Patient Problem Burn(s) (1757)

Event Date 03/18/2014

Event Type  Injury  

Event Description

The manufacturer rec'd info alleging a patient was smoking a cigarette while using an everflo oxygen concentrator.The cigarette ignited a fire, which allegedly burned the patient.Reportedly, the patient had burns to face, nose, throat, and lungs and was admitted to the hospital.The device has yet to be returned to the manufacturer for evaluation.A f/u report will be submitted when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer has completed the investigation of a patient that was allegedly smoking a cigarette while using an everflo oxygen concentrator.The patient received burns to their face,nose, throat and lungs and was hospitalized.The manufacturer received information that the device is not returning to the manufacturer for evaluation.The distributor reported to the manufacturer that the device was scrapped due to the extensive damage sustained during the fire.Product labeling states," do not smoke or allow others to smoke or have open flames near the concentrator when it is in use." based on the available information, the device did not cause the event.

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS INC; 175 chastain meadows court; kennesaw GA 30144
• Manufacturer (Section G): RESPIRONICS INC; 175 chastain meadows court; kennesaw GA 30144
• Manufacturer Contact: wilfredo alvarez ; 1740 golden mile highway; monroeville, PA 15146 ; 7243875658
• MDR Report Key: 3799668
• MDR Text Key: 4530334
• Report Number: 1040777-2014-00009
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 04/03/2014

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: Health Professional
• Device Model Number: 1020010
• Device Catalogue Number: 1020010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/12/2015
• Initial Date FDA Received: 04/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention