DeRoyal M2200-CP-CS2Recalls & reported problems

Deroyal Industries, Inc. · Chair Sensor Pad · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 00749756980456), received between Dec 10, 2021 and Dec 10, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “No Audible 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 18, 2026.

Most reported problems

Device problems

No Audible Alarm1

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.

MalfunctionDec 10, 2021No Audible Alarm; No Audible Alarm
CHAIR SENSOR PAD FOR CHAIR ALARM FOR FALL PRECAUTIONS ARE NOTED TO FAIL WHEN THE PATIENT STANDS AND THE ALARM DOES NOT GO OFF. CHAIR SENSOR PAD AND CONNECTIVITY POINT TO THE PORTABLE CHAIR ALARM BOX APPROPRIATELY ENGAGED, BATTERIES ARE OK. TESTING WITH A NEW CHAIR PAD TO THE CHAIR ALARM BOX WORKS WELL. ADDITIONALLY, IF CHAIR SENSOR PAD GETS WET FROM INCONTINENCE THROUGH INCONTINENCE PADS ON THE CHAIR (OVER THE CHAIR SENSOR PAD), THE CHAIR SENSOR WILL ALSO NOT WORK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12976455 ↗

Device details

UDI-DI	`00749756980456`
Brand	DeRoyal
Model	M2200-CP-CS2
Company	Deroyal Industries, Inc.
Product code	KMI · MONITOR, BED PATIENT
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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