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

Model Number	M10600
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging the oxygen tubing on a millennium oxygen concentrator caught fire.There was no report of patient harm or injury.The device was returned to the manufacturer's service center for evaluation.The customer's complaint was not confirmed.There was no evidence of thermal damage to the device.Product labeling states, " do not smoke, allow others to smoke, or have open flames near the concentrator when it is in use.Smoking during oxygen therapy is dangerous and is likely to result in facial burns or death.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.".

• Brand Name: MILLENNIUM M10
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• MDR Report Key: 7846351
• Report Number: 1040777-2018-00034
• Device Sequence Number: 16761443
• Product Code: CAW
• UDI-Device Identifier: 00606959015678
• UDI-Public: 00606959015678
• 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
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2018

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: M10600
• Device Catalogue Number: M10600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR