Millennium M10 Concentrator
Received Jul 31, 2026 · Event occurred Jun 26, 2026
Report 2518422-2026-040891 · MDR key 50104314
Device
Generic name
Generator, Oxygen, Portable
Manufacturer
Respironics, Inc.Model number
M10600Catalog number
M10600
Product problems
- Thermal Decomposition of Device
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
The manufacturer received a work order reporting that the Millennium M10 Concentrator device exhibited red light. During the evaluation of the device at the third-party service center, the device was visually inspected and thermal damage was detected.Additionally, the service technician also noted leakage and dirt.
Additional Manufacturer Narrative
The reported failure of thermal issue is accomadated in the product risk management file as being linked to Hazard with description Fire, flame, smoke. Complaints for this failure are reviewed via the Post Market complaint trending and escalation processes to assess for the observed probability levels and compare them with the predicted levels in the risk file for the hazards linked to the failure. As of the date of submission for this report, there is no further indication that complaints for the failure in question has led to unacceptable increase in probability levels for the hazardous situations in scope, and therefore no further action will be pursued. QA continues to monitor complaints for this issue per the cadence in the Complaint Trending procedures.