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

Model Number	M10605
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a millennium oxygen concentrator caught on fire.There was no report of patient harm or injury.The device has yet to be returned to the manufacturer's service center.A follow up final report will be filed when the manufacturer has completed the investigation.
Additional Manufacturer Narrative
The manufacturer previously reported a millennium oxygen concentrator allegedly caught on fire.There was no report of patient harm or injury.The device was returned to the manufacturer's service center for evaluation.The technician found the compressor wires were cut caused by the mounting brackets of the compressor.There was evidence of thermal damage to the compressor bracket.The enclosure of the device was not compromised.

• Brand Name: MILLENNIUM OXYGEN CONCENTRATOR
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• MDR Report Key: 7067752
• Report Number: 1040777-2017-00037
• Device Sequence Number: 685106
• Product Code: CAW
• UDI-Device Identifier: 00606959015685
• UDI-Public: 00606959015685
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K972614
• 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): 11/07/2017

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: M10605
• Device Catalogue Number: M10605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1