DeRoyal M2100-SL2Recalls & reported problems

Deroyal Industries, Inc. · Safety Auto-Reset Fall Monitor · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756980449), received between Dec 13, 2023 and Dec 13, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Delayed Alarm” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Delayed Alarm1

Patient problems

Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Depression1

Recent adverse event reports

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

InjuryDec 13, 2023Delayed Alarm; Delayed Alarm
ACCORDING TO THE NURSING STAFF, THE PATIENT WAS OOB (OUT OF BED) AND THE BED ALARM FAILED TO ALARM TIMELY. WHEN THEY HEARD THE ALARM, THE PATIENT WAS ALREADY ON THE FLOOR. THUS, THE STAFF FEEL THAT THERE WAS A DELAY IN THE ALARM.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Depression
MAUDE report 18317876 ↗

Device details

UDI-DI	`00749756980449`
Brand	DeRoyal
Model	M2100-SL2
Company	Deroyal Industries, Inc.
Product code	KMI · MONITOR, BED PATIENT
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 13, 2023

Device type (GMDN): Bed/chair occupant movement pressure/vibration sensor

An electrically-powered electronic sensing pad (pressure- or mechanical vibration-sensing) designed to be placed under a bed and/or chair occupant to detect and/or measure occupant movement related to activities such as sleep, wakefulness, and/or bed/chair exit. Some types are able to detect in addition occupant respiration and heart rates; and some types function with an alarm/alert/notification system to indicate unattended occupant attempt to vacate bed/chair.

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All MONITOR, BED PATIENT devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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