CARESCAPE Central Station v1Recalls & reported problems

Ge Medical Systems Information Technologies, Inc. · ASSY CSCS V1 MP100D DESKTOP · Class 2

All models of CARESCAPE (3)

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

Adverse event reports: 2
Deaths reported: 1
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840682109826), received between May 8, 2024 and Jun 26, 2025 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Device Alarm System” (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

Device Alarm System1
Insufficient Device Problem Information1
No Audible Alarm1

Patient problems

Insufficient Information1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

DeathJun 26, 2025Device Alarm System; Insufficient Device Problem Information; Device Alarm System; Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT DEATH OCCURRED, ALLEGEDLY WITHOUT APPROPRIATE ALARMS PROVIDED BY THE DEVICE.
Patient problems: Insufficient Information
MAUDE report 22338937 ↗
MalfunctionMay 8, 2024No Audible Alarm; No Audible Alarm
IT WAS REPORTED THAT THE CSCS V1 WAS NOT AUDIBLY ALARMING. THE VISUAL ALARMS WERE STILL PRESENT. THERE WAS NO RELATED ADVERSE PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19269804 ↗

Device details

UDI-DI	`00840682109826`
Brand	CARESCAPE
Model	Central Station v1
Company	Ge Medical Systems Information Technologies, Inc.
Product code	CBQ · ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Apr 22, 2025

Device type (GMDN): Centralized patient monitor

A mains electricity (AC-powered) device designed to receive continuous, interval and/or spot-check physiological data (e.g., vital signs) from one or more bedside patient monitor(s) (not included) to display this information at a central patient monitoring station where staff can monitor multiple patients simultaneously. It is comprised of hardware with integrated software and is especially used in critical care settings, producing visible and/or audible signals/alarms when adverse conditions are registered. Additional features may include Holter/ST-segment monitoring and patient data transfer [e.g., into an electronic medical record (EMR)].

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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