C6 Monitor 02-01549Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI B146C6M40), received between Apr 25, 2023 and Jul 6, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2023Overheating of Device; Overheating of Device

  THE PATIENT REPORTED AN OVERHEAT WHILE CHARGING THE MONITOR. THE PATIENT WAS NOT INJURED AND THEREFORE DID NOT SEEK MEDICAL ATTENTION. IT IS UNKOWN IF THE CHARGING CORD WAS WARM AS THE PATIENT DID NOT CHECK/RECALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17268702 ↗
• MalfunctionJul 6, 2023Overheating of Device; Overheating of Device

  THE PATIENT REPORTED THAT THE MONITOR WAS HOT WHEN CHARGING. WHEN UNPLUGGING THE CORD AND THE METAL PART OF USB PORT IT WAS NOTED TO BE HOT. THE PATIENT WAS NOT HARMED AND DID NOT NEED TO SEEK MEDICAL ATTENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17266299 ↗
• MalfunctionApr 25, 2023Temperature Problem; Excessive Heating; Temperature Problem; Excessive Heating

  IT WAS INITIALLY REPORTED BY BIOTEL HEART THAT THE CHARGING PORT WAS MELTED. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY TO PATIENT, OPERATOR, OR BYSTANDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809499 ↗