Millennium M10 Millennium M10 Oxygen Percentage Indicator Concentrator, USRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00606959015685), received between Nov 29, 2017 and Aug 4, 2023 — classified as 1 death, 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2023Thermal Decomposition of Device; Device Emits Odor; Overheating of Device; Thermal Decomposition of Device; Device Emits Odor; Overheating of Device

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17458520 ↗
• InjuryJan 21, 2022Battery Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGINGA MILLENNIUM OXYGEN CONCENTRATOR SHUT OFF WITHOUT AN ALARM. THE PATIENT WAS TAKEN TO THE HOSPITAL BY AMBULANCE. THE PATIENT WAS DIAGNOSED WITH BACTERIAL PNEUMONIA AND PLACED ON A VENTILATOR. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR FURTHER INVESTIGATION. THE DEVICE WAS VISUALLY INSPECTED AND WAS FOUND TO HAVE EVIDENCE OF PHYSICAL DAMAGE. THE DEVICE WAS TESTED AND WAS FOUND TO PROVIDE THERAPY PROPERLY. THE CUSTOMER'S COMPLAINT OF THE DEVICE NOT ALARMING WAS CONFIRMED. THE TECHNICIAN FOUND THE 9VOLT BATTERY USED TO POWER THE LOSS OF POWER ALARM SOURCE WAS DEPLETED, CAUSING THE DEVICE TO NOT ALARM IF AC POWER WAS LOST. PRODUCT LABELING STATES,"IF THE DEVICE IS TURNED ON BUT NOT OPERATING, THE ALARM CONDITION WILL BE ACTIVIATED. THIS IS OFTEN THE RESULT OF EITHER THE DEVICE NOT BEING PLUGGED IN OR A POWER FAILURE. THE FEATURE IS POWERED BY AN INTERNAL 9V BATTERY. TO TEST THE CONDITION OF THE BATTERY YOU SHOULD TEST THIS ALARM STATE OFTEN BY UNPLUGGING THE DEVICE AND SWITCHING THE POWER ON. IF THE ALARM CONDITION IS NOT ACTIVATED, YOU SHOULD CONTACT YOUR HOME CARE PROVIDER TO REPLACE THE BATT

  Patient problems: Respiratory Insufficiency

  MAUDE report 13316151 ↗
• DeathMar 3, 2021Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A MILLENNIUM OXYGEN CONCENTRATOR WAS INVOLVED IN A HOUSE FIRE AND THE PATIENT EXPIRED. THE DEVICE IS NOT RETURNING TO THE MANUFACTURER FOR EVALUATION. BASED ON THE AVAILABLE INFORMATION, IT WAS REPORTED THAT THE FIRE WAS CAUSED BY SMOKING IN THE HOME. THERE IS NO ALLEGATION OF DEVICE MALFUNCTION HAVING OCCURRED. 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: Insufficient Information

  MAUDE report 11405890 ↗
• MalfunctionNov 29, 2017Fire

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A MILLENNIUM OXYGEN CONCENTRATOR CAUGHT ON FIRE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER'S SERVICE CENTER. A FOLLOW UP FINAL REPORT WILL BE FILED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7067752 ↗