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

Model Number 1020000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 10/13/2016

Event Type  Injury  

Event Description

The manufacturer received a voluntary medwatch, reference number, (b)(4), alleging a patient received second and third degree burns to their nose and face when a cigarette was lit while using an everflo oxygen concentrator.The device is not being returned to the manufacturer's service center for evaluation.There was no allegation of device malfunction that caused or contributed to the event.Product labeling, " 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
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS INC; 175 chastain meadows court; kennesaw GA 30144
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: wilfredo alvarez ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 6089218
• MDR Text Key: 59500283
• Report Number: 1040777-2016-00033
• 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: user facility
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/25/2016

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: 1020000
• Device Catalogue Number: 1020000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2016
• Initial Date FDA Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 61 YR