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

Model Number 1020000

Device Problem Smoking (1585)

Patient Problem Burn(s) (1757)

Event Date 12/10/2015

Event Type  Injury  

Event Description

The manufacturer received information alleging a patient was smoking a cigarette while using an everflo oxygen concentrator.The patient received second degree burns and was hospitalized.The fire marshall confirmed the cause of the fire was the patient smoking a cigarette while using the device.The device was evaluated by a third party service center.The device had no evidence of thermal damage to any internal components.The exterior of the device had evidence of thermal damage caused by an external source.The device was repaired and placed back into service.Product labeling 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; 175 chastain meadows court; kennesaw GA 30144
• Manufacturer (Section G): RESPIRONICS INC; 175 chastain meadows court; kennesaw GA 30144
• Manufacturer Contact: wilfredo alvarez ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 5477668
• MDR Text Key: 39607544
• Report Number: 1040777-2016-00010
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1020000
• Device Catalogue Number: 1020000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2011
• 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: 66 YR