Omega-S Solution MS25490Recalls & reported problems

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 04049098002172), received between Aug 21, 2024 and Aug 21, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unable to Obtain 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.

Reports received per month

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

Most reported problems

Device problems

Unable to Obtain Readings1

Patient problems

Insufficient Information1

Recent adverse event reports

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

MalfunctionAug 21, 2024Unable to Obtain Readings; Unable to Obtain Readings
THE CUSTOMER REPORTED THAT ON (B)(6) 2024, THE USER FOUND THAT THE KAPPA COULD NOT MONITOR BLOOD PRESSURE UNDER ANESTHESIA, AND REPORTEDLY AFFECTED THE TREATMENT PROCESS. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT, AND THAT THE DEPARTMENT IMMEDIATELY REPLACED THE PATIENT MONITORING DEVICE. NO ADVERSE PATIENT IMPACT OR DEATH WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 20013853 ↗

Device details

UDI-DI	`04049098002172`
Brand	Omega-S Solution
Model	MS25490
Company	Draeger Medical Systems, Inc.
Product code	MSX · System,Network And Communication,Physiological Monitors
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 10, 2021

Device type (GMDN): General-purpose multi-parameter bedside monitor

An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.