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

Model Number	1020014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an everflo oxygen concentrator was involved in a house fire.There was no report of patient harm or injury.The investigation is still ongoing.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 was allegedly involved in a house fire.There was no report of patient harm or injury.Repeated attempts to have the device returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
Additional Manufacturer Narrative
The manufacturer previously reported an everflo oxygen concentrator was allegedly involved in a house fire.There was no report of patient harm or injury.The manufacturer retained a fire investigator to examine the fire scene where the everflo oxygen concentrator components were recovered from the debris.A subsequent laboratory examination of the recovered components was performed.No evidence of an internal failure was observed on any of the wiring or electrical components.No evidence was observed to indicate that the concentrator failed in any manner to cause the fire.The manufacturer concludes that the everflo oxygen concentrator was not the cause of the fire.

• Brand Name: EVERFLO OXYGEN CONCENTATOR
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• MDR Report Key: 7049010
• Report Number: 1040777-2017-00035
• Device Sequence Number: 1069320
• Product Code: CAW
• UDI-Device Identifier: 00606959032620
• UDI-Public: 00606959032620
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1020014
• Device Catalogue Number: 1020014
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 02/02/2018; 04/17/2018
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 02/08/2018; 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1