Millennium M10 Millennium M10 Concentrator, USRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00606959015678), received between Dec 28, 2016 and Mar 11, 2026 — classified as 5 deaths, 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fire” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• DeathMar 11, 2026Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A PATIENT WITH A MILLENNIUM M10 CONCENTRATOR DEVICE IS DECEASED. THE REPORTED EVENT MAKES NO ALLEGATION OF ANY SPECIFIC DEVICE MALFUNCTION, USE ERROR, FAILURE, LABELING, OR OTHER DEFICIENCY THAT IS RELEVANT TO THE HARMS REPORTED. THEREFORE, BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. A REPORT WILL BE FILED WITH ALL REGULATORY AGENCIES.

  Patient problems: Insufficient Information

  MAUDE report 24565878 ↗
• InjuryDec 9, 2025Fire; Improper or Incorrect Procedure or Method; Fire; Improper or Incorrect Procedure or Method

  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.

  Patient problems: Burn(s); Pain; Skin Inflammation/ Irritation

  MAUDE report 23762785 ↗
• InjuryApr 10, 2024Fire; Fire

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DEVICE CAUGHT ON FIRE AND BURNED THE PATIENT. THE PATIENT'S REPRESENTATIVE REPORTED THERE WAS NO SMOKING, AND THE PATIENT DID REPORT TO THE EMERGENCY ROOM WITH REPORTED BURNS. MEDICAL INTERVENTION WAS NOT SPECIFIED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Burn(s)

  MAUDE report 19078601 ↗
• DeathJan 18, 2023No Audible Alarm; No Audible Alarm

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A MILLENNIUM M10 OXYGEN CONCENTRATOR HAD A YELLOW LIGHT BUT NOT ALARMING AND THE DEVICE'S OXYGEN CONCENTRATION WAS AT 72%. THE PATIENT EXPIRED WHILE USING THE DEVICE. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR FURTHER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

  Patient problems: Insufficient Information

  MAUDE report 16196503 ↗
• DeathJun 6, 2022No Flow; No Flow

  THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH (MW5107134) ALLEGING A MILLENNIUM OXYGEN CONCENTRATOR STOPPED WORKING AND DID NOT ALARM. THE PATIENT'S BLOOD OXYGEN LEVEL DECREASED AND WAS PLACED ON A BACK UP SUPPLY OF OXYGEN. THE PATIENT DID NOT RECOVER FROM THE EVENT AND EXPIRED A FEW DAYS LATER. THE DEVICE IS NOT RETURNING TO THE MANUFACTURER FOR EVALUATION. THE DEVICE IS CURRENTLY BEING USED BY ANOTHER PATIENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 14606055 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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."

  Patient problems: Burn(s)

  MAUDE report 11737517 ↗
• MalfunctionSep 5, 2018Fire; Fire

  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."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7846351 ↗
• DeathFeb 28, 2018Adverse Event Without Identified Device or Use Problem; Fire; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A MIILLENNIUM M10 OXYGEN CONCENTRATOR WAS INVOLVED IN A HOUSE FIRE. THE PATIENT EXPIRED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

  Patient problems: Death

  MAUDE report 7303286 ↗
• DeathFeb 28, 2018Adverse Event Without Identified Device or Use Problem; Fire; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A MILLENNIUM OXYGEN CONCENTRATOR THAT WAS INVOLVED IN A HOUSE FIRE. THE CARETAKER EXPIRED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

  Patient problems: Death

  MAUDE report 7303282 ↗
• InjuryDec 28, 2016Improper Flow or Infusion; Improper Flow or Infusion

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A MILLENNIUM OXYGEN CONCENTRATOR DID NOT HAVE STEADY FLOW AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION. THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DISS OUTLET IS CRACKED. THE DISS OUTLET WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6210104 ↗