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

Model Number	M10605
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Device Emits Odor (1425); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware that a millennium m10 concentrator had a burning plastic smell when first using the device.The user's husband reported the smell eventually went away after using the device, but when he went to change the cabinet filter, the filter cover was cracked and melted.The user's husband states he does not know if his wife was harmed, but they will be following up with a physician.The dme was contacted and is sending a new concentrator and the user reported having a backup device to use in the meantime.There was no report of smoke, flames, voids, or exposed ac wires.There was no report of medical intervention.The device has not been returned to the manufacturer.Attempts to contact the dme for return of the device have been unsuccessful since the user's name and date of birth were unknown.Attempts to contact the user for more information were unsuccessful due to the phone number listed is not accurate.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
Additional Manufacturer Narrative
Device not returned to manufacturer.
Additional Manufacturer Narrative
The manufacturer previously reported device problem code as thermal decomposition of device-c63286.After review, it was determined the device problem code should have been overheating of device c62883.

• Brand Name: MILLENIUM M10 OXYGEN CONCENTRATOR
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17458520
• Report Number: 2518422-2023-18307
• Device Sequence Number: 7105973
• Product Code: CAW
• UDI-Device Identifier: 00606959015685
• UDI-Public: 00606959015685
• Combination Product (Y/N): N
• 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,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 08/04/2023
• Date Device Manufactured: 10/05/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown