MAUDE Adverse Event Report: PHILIPS RESPIRONICS INC. MILLENNIUM M10; GENERATOR, OXYGEN, PORTABLE

Model Number	M10605
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2021
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a millennium oxygen concentrator was involved in a house fire and the patient expired.The device is not returning to the manufacturer for evaluation.Based on the available information, it was reported that the fire was caused by smoking in the home.There is no allegation of device malfunction having occurred.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: MILLENNIUM M10
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): PHILIPS RESPIRONICS INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 11405890
• Report Number: 2518422-2021-00580
• Device Sequence Number: 19676137
• Product Code: CAW
• UDI-Device Identifier: 00606959015685
• UDI-Public: 00606959015685
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K043006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2021

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: M10605
• Device Catalogue Number: M10605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/03/2021
• 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: Death