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

Model Number	M10600
Medical Device Problem Codes	Fire (1245); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Burn(s) (1757); Pain (1994); Skin Inflammation/ Irritation (4545)
Date of Event	11/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received a voluntary medwatch with uf/importer report #(b)(6) alleging a patient suffered burns to the face, upper lips, left eyebrow, eyelashes, and scabbing in the nasal passages due to oxygen igniting while the patient was smoking with oxygen on via nasal cannula while using a millenium m10 concentrator device.The patient reports the oxygen in the device ignited but the patient was able to extinguish it quickly.The patient denied difficulty breathing and there were no injuries visible to the patient's throat or oral cavity.The patient reported the pain was at 2/10 at the time.The patient states they were educated to not smoke with oxygen and on the risks of fire/injury but had proceeded to do so.The oxygen concentrator and tubing were replaced.No medical intervention was specified.A final report is being submitted.If new information becomes available, a follow-up/supplemental report will be completed.
Additional Manufacturer Narrative
The manufacturer received a voluntary medwatch with uf/importer report #(b)(4) alleging a patient suffered burns to the face, upper lips, left eyebrow, eyelashes, and scabbing in the nasal passages due to oxygen igniting while the patient was smoking with oxygen on via nasal cannula while using a millenium m10 concentrator device.The patient reports the oxygen in the device ignited but the patient was able to extinguish it quickly.The patient denied difficulty breathing and there were no injuries visible to the patient's throat or oral cavity.The patient reported the pain was at 2/10 at the time.The patient states they were educated to not smoke with oxygen and on the risks of fire/injury but had proceeded to do so.The oxygen concentrator and tubing were replaced.No medical intervention was specified.A final report is being submitted.If new information becomes available, a follow-up/supplemental report will be completed.This correction report is being filed to correctly list the importer medwatch report (b)(4) in block h10, related report field.

• Brand Name: MILLENNIUM M10
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 23762785
• Report Number: 2518422-2025-112469
• Device Sequence Number: 13281752
• Product Code: CAW
• UDI-Device Identifier: 00606959015678
• UDI-Public: (01)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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 43 KG
• Patient Race: White