DeRoyal M2300-NCRecalls & reported problems

Deroyal Industries, Inc. · NURSE CALL CORD · 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 00749756847711), received between Aug 3, 2023 and Aug 3, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (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.

Most reported problems

Device problems

Off-Label Use1
Use of Device Problem1

Patient problems

Cardiac Arrest1

Recent adverse event reports

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

InjuryAug 3, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem
PATIENT SUCCESSFULLY WRAPPED CALL LIGHT CORD ATTACHED TO INPATIENT BED AROUND NECK, CAUSING CARDIAC ARREST, CODE BLUE EVENT. PATIENT WAS RESUSCITATED AND TRANSFERRED TO ICU FOLLOWING EVENT.
Patient problems: Cardiac Arrest
MAUDE report 17452041 ↗

Device details

UDI-DI	`00749756847711`
Brand	DeRoyal
Model	M2300-NC
Company	Deroyal Industries, Inc.
Product code	KMI · MONITOR, BED PATIENT
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 11, 2021

Device type (GMDN): Medical device service rail system

An assembly of devices and components designed to provide a secure method of fixing/mounting/organizing medical/non-medical devices being used in the vicinity of the patient for treatment/care and to provide services. It is typically be used in hospital wards, treatment rooms or intensive care units (ICU) where there is a demand for built-in amenities (e.g., electricity, medical gases, nurse call system and/or intercom systems). It is fixed to the wall or built onto the wall. The rail will have a preformed cross-section incorporating a safety design compatible to the clamps and holders to be used with the rail to provide the mounting method. It is typically supplied in prefabricated units.

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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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