DeRoyal V81-010400Recalls & reported problems

Deroyal Industries, Inc. · Skin 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 00749756778213), received between Oct 30, 2020 and Oct 30, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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.

Most reported problems

Device problems

Incorrect, Inadequate or Imprecise Result or Readings1
Low Readings1
Output Problem1

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 30, 2020Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Output Problem
A TEMPERATURE PROBE WAS USED ON A PATIENT. THE PROBE WAS ONLY READING UP TO 92 DEGREES. THE PROBE WAS CONNECTED VIA AN INTERFACE CABLE TO A PHILLIPS MONITOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10765577 ↗

Device details

UDI-DI	`00749756778213`
Brand	DeRoyal
Model	V81-010400
Company	Deroyal Industries, Inc.
Product code	FLL · Thermometer, electronic, clinical
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): General-purpose patient temperature probe, single-use

A temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. 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.