DeRoyal 81-040412Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00749756045995), received between Apr 10, 2019 and Jan 2, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 2, 2026Incorrect Interpretation of Signal

  A USER FACILITY REPORTED, "TEMPERATURE IS RISING AND DROPPING, FOR EXAMPLE FROM 36 DEGREES, DOWN TO 31 DEGREES SUDDENLY. BEFORE RETURNING TO 36 DEGREES. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943868 ↗
• MalfunctionNov 6, 2019Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE TEMPERATURE READING WAS STUCK AT 28.3 DEGREES CELSIUS. THIS OCCURRED DURING USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9284261 ↗
• MalfunctionApr 10, 2019Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  DURING A DENTAL CASE, THE ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR STOPPED READING THE PATIENT'S TEMPERATURE. A SKIN PROBE WAS PULLED TO THE PATIENT'S TEMPERATURE COULD CONTINUE BEING MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8500822 ↗