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

Model Number 1039370

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

Patient Problem Burn(s) (1757)

Event Date 05/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The manufacturer received information alleging a patient was smoking a cigarette while using an everflo oxygen concentrator.The patient received burns and was taken to the hospital and released on the same day.The device is not returning to the manufacturer for evaluation.There was no allegation of device malfunction that occurred.The durable medical equipment (dme) supplier confirmed the fire originated at the end of the nasal cannula.The device has evidence of thermal damage to the enclosure and to the power cord.The dme has scrapped the device.The dme returned to the patient's home to collect the damaged equipment and found the patient smoking a cigarette.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
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• Manufacturer (Section G): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• Manufacturer Contact: adam price ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 7553355
• MDR Text Key: 109534039
• Report Number: 1040777-2018-00022
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959020436
• UDI-Public: 00606959020436
• 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,user facility
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/24/2018

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: 1039370
• Device Catalogue Number: 1039370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2014
• 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): Required Intervention
• Patient Age: 69 YR