DeRoyal 81-020409Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00749756046145), received between Aug 20, 2020 and Mar 9, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Incorrect Interpretation of Signal” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Failure to Sense

  A USER FACILITY REPORTED VIA A MEDWATCH, "ESOPHAGEAL TEMP PROBE PLACED FOR CORE TEMP MONITORING WITH WHOLE BODY COOLING PROTOCOL. PLUGGED ESOPHAGEAL TEMP PROBE INTO CORD CONNECTED TO BLANKETEROL AND THE MACHINE DID NOT RECOGNIZE A TEMPERATURE AND ALARMED CHECK PROBE. BLANKETEROL TEMP CORD PLUGGED INTO RECTAL TEMP PROBE AND WORKED. AFTER CONFIRMING THAT THE CORD FROM THE BLANKETEROL WAS WORKING TRIED TO USE WITH ESOPHAGEAL TEMP PROBE AGAIN BUT IT WOULD NOT READ A TEMPERATURE. REMOVED ESOPHAGEAL PROBE AND PLACED A NEW ONE. NEW ESOPHAGEAL PROBE READING WITHOUT ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24548589 ↗
• MalfunctionFeb 19, 2026Incorrect Interpretation of Signal

  A USER FACILITY REPORTED, "TEMPERATURE MONITORING PROBE BOUNCING AND HAVING FLUCTUATIONS DURING PROCEDURES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388013 ↗
• MalfunctionFeb 19, 2026Incorrect Interpretation of Signal

  A USER FACILITY REPORTED, "TEMPERATURE MONITORING PROBE BOUNCING AND HAVING FLUCTUATIONS DURING PROCEDURES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388012 ↗
• MalfunctionJan 2, 2026Failure to Analyze Signal; Incorrect Interpretation of Signal

  A USER FACILITY REPORTED, "THERE IS POOR CONTACT BETWEEN PROBE AND CABLE, CAUSING LOSS OF THE TEMPERATURE READING. WE KEEP REPLACING THE PROBE UNTIL WE FIND ONE THAT WORKS. THIS CAUSES SIGNIFICANT WASTE RESULTING IN UNJUSTIFIED CONSUMPTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943870 ↗
• MalfunctionJan 2, 2026Incorrect Interpretation of Signal

  A USER FACILITY REPORTED, "WE HAVE RECEIVED MULTIPLE COMPLAINTS REGARDING THE CABLES, WHICH ARE NOT FUNCTIONING PROPERLY. AS A RESULT, THEY ARE CAUSING ERRORS IN THE MONITORING OF PATIENTS' TEMPERATURES ACROSS ALL THE HOSPITALS WE SUPPLY TO."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943869 ↗
• InjuryApr 29, 2021Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CUSTOMER A PIECE OF THE TEMPERATURE PROBE WAS BROKEN OFF AND FOUND INSIDE THE PATIENT STOMACH. PATIENT POTENTIALLY BIT OFF THE PROBE PER SUS VOLUNTARY EVENT REPORT (MW5100669). THE SUS VOLUNTARY EVENT REPORT STATED THE FOLLOWING: PATIENT COMPLAINS OF ABDOMEN DISTENTION AND NAUSEA. ABDOMEN WITHOUT PERITONITIS OR GUARDING. OBSTRUCTION SERIES SHOWS DILATED SMALL BOWL, AIR IN COLON CONCERN FOR ILEUS. BUT ALSO SHOWS A RETAINED OBJECT IN LUQ THAT IS CONCERNING FOR PORTION OF DOBHOFF TUBE (FEEDING TUBE) VS ESOPHAGEAL TEMP PROBE THAT APPEARS TO BE IN THE STOMACH. CHEST X-RAY SHOWED INTACT DOBHOFF COURSING THROUGH ESOPHAGUS INTO STOMACH GI CONSULTED FOR ESOPHAGOGASTRODUODENOSCOPY (EGD). EGD APPEARED TO BE A FRACTURED DOBHOFF TUBE IN THE BODY OF THE STOMACH THAT EXTENDED INTO THE ANTRUM AND INTO THE DUODENUM. SOME GASTRITIS WITH HEMATIN LIKELY FROM THE TRAUMA FROM THE PRESENCE OF A FOREIGN BODY IN THIS REGIN. PATHOLOGY REPORT OF A 0.3 CM IN DIAMETER RUBBERY TAN WHITE RUBBER COATED WIRE. SOUNDS LIKE THE ESOPHAGEAL PROBE. PATIENT WAS AGITATED IN ICU AND MAY HAVE BITTEN THROUGH THE WIRE.

  Patient problems: Gastritis; Unspecified Gastrointestinal Problem

  MAUDE report 11744372 ↗
• MalfunctionAug 20, 2020Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A TEMPERATURE PROBE WAS FOUND IN THE RIGHT MAINSTEM BRONCHUS DURING TRANSESOPHAGEAL TEMPERATURE MONITORING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10431547 ↗