Millennium M10 Millennium M10 O2 Percent Ind, Transfill,120V, US/CARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959012776), received between Dec 18, 2018 and Dec 18, 2018 — classified as 1 death.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathDec 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A MILLENNIUM M10 OXYGEN CONCENTRATOR WAS NOT WORKING PROPERLY. THE PATIENT BECAME HYPOXIC AND WAS TAKEN TO THE HOSPITAL BY AMBULANCE WHERE SHE LATER EXPIRED. THE DEVICE IS NOT RETURNING TO THE MANUFACTURER AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

  Patient problems: Death

  MAUDE report 8173952 ↗