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

Model Number	1039363
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Respiratory Distress (2045); Burn, Thermal (2530)
Date of Event	02/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a patient lit a cigarette while using an everflo oxygen concentrator.The patient was admitted to the hospital with facial burns and smoke inhalation.There was no allegation of device malfunction.The device has yet to be returned to the manufacturer for evaluation.A follow up report will be submitted when the manufacturer has completed the investigation.
Additional Manufacturer Narrative
The manufacturer previously reported an everflo oxygen concentrator that a patient allegedly lit a cigarette while using.The patient was admitted to the hospital with facial burns and smoke inhalation.There was no allegation of device malfunction.The device was returned to the manufacturer's service center for evaluation.The device was visually inspected and found no evidence of fire damage.The device was contaminated with cigarette odor.The device was tested and was found to have a low oxygen concentration.The device is not being repaired by the request of the durable medical equipment (dme) supplier.

• 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: 7270678
• Report Number: 1040777-2018-00007
• Device Sequence Number: 13926537
• Product Code: CAW
• UDI-Device Identifier: 00606959032675
• UDI-Public: 00606959032675
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2018

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
• Operator of Device: Lay User/Patient
• Device Model Number: 1039363
• Device Catalogue Number: 1039363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 02/14/2018
• Supplement Report FDA Received Date: 04/10/2018
• 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: Hospitalization
• Patient Age: 78 YR