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

Model Number	1020010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	10/03/2016
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a patient was smoking a cigarette while using an everflo oxygen concentrator.The nasal cannula ignited and the patient reportedly expired from his injuries.The device was returned to the reporting facility for evaluation on 10/15/2016.The device was evaluated and was found to operate properly.There was no evidence of thermal damage observed.The device was returned to the rental stock.The device is currently in patient use.Product labeling states," oxygen vigorously accelerates combustion and should be kept away from heat or open flame.Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.Do not smoke, allow others to smoke or have open flames near the concentrator when it is in use.".

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• MDR Report Key: 6407128
• Report Number: 1040777-2017-00010
• Device Sequence Number: 13530534
• Product Code: CAW
• UDI-Device Identifier: 00606959001077
• UDI-Public: 00606959001077
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date (Section B): 03/08/2017

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
• Operator of Device: Lay User/Patient
• Device Model Number: 1020010
• Device Catalogue Number: 1020010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2017
• Initial Report FDA Received Date: 03/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 66 YR