DeRoyal 81-050418Recalls & reported problems

Deroyal Industries, Inc. · Esophageal Stethoscope w/Temperature Sensor · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756045940), received between Oct 29, 2025 and Oct 29, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect Interpretation of Signal” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Incorrect Interpretation of Signal1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 29, 2025Incorrect Interpretation of Signal; Incorrect Interpretation of Signal
A USER FACILITY REPORTED, "PRODUCTS TEMP IS JUMPING FROM 36 TO 48 TO 8 TO 15. TOO MUCH VARIANCE IN READINGS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23416848 ↗

Device details

UDI-DI	`00749756045940`
Brand	DeRoyal
Model	81-050418
Company	Deroyal Industries, Inc.
Product code	BZT · STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 29, 2018

Device type (GMDN): Electronic oesophageal stethoscope, single-use

An electronic listening device designed to be inserted into a patient's oesophagus to listen to heart and breathe sounds, typically while the patient is under anaesthesia. Some types may also have a temperature sensor to monitor the patient's temperature. The device will typically contain integral electrical conductors, thermistors/temperature sensors for proximal connection to a patient monitoring device, and include a proximal connector for a standard earpiece. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.