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

Model Number	M10600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/29/2017
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a miillennium m10 oxygen concentrator was involved in a house fire.The patient expired.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 a millennium m10 oxygen concentrator was allegedly involved in a house fire.The patient expired.The device was evaluated by a third party investigation.The third party investigator confirms the millennium oxygen concentrator was not the origin of the fire.The fire did not originate in the room where the oxygen concentrator was being used.The trail left in the carpet from the burning cannula indicates the device was operating and producing oxygen as manufactured at the time of the event.The manufacturer concludes the fire originated from an external source.

• Brand Name: MILLENNIUM M10 OXYGEN CONCENTRATOR
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• MDR Report Key: 7303286
• Report Number: 1040777-2018-00009
• Device Sequence Number: 16462848
• Product Code: CAW
• UDI-Device Identifier: 00606959015678
• UDI-Public: 00606959015678
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K043006
• 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
• Report Date (Section B): 02/26/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: M10600
• Device Catalogue Number: M10600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 07/10/2018
• 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: Death; Required Intervention