MAUDE Adverse Event Report: MILLENNIUM M10 OXYGEN CONCENTRRATOR; GENERATOR, OXYGEN, PORTABLE

Model Number	M10600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a patient was smoking a cigarette while using a millennium m10 oxygen concentrator.The patient was taken to the hospital.The device is not returning to the manufacturer for evaluation.The device is still in patient use.The durable medical equipment (dme) supplier confirmed the device worked properly and instructed the family to not smoke anywhere near the oxygen concentrator.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 OXYGEN CONCENTRRATOR
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• MDR Report Key: 11737517
• Report Number: 2518422-2021-01186
• Device Sequence Number: 14487817
• Product Code: CAW
• UDI-Device Identifier: 00606959015678
• UDI-Public: 00606959015678
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/28/2021

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: M10600
• Device Catalogue Number: M10600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 04/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization