N/A B125 Patient MonitorRecalls & reported problems

Ge Medical Systems Information Technologies, Inc. · B125 V1 PATIENT MONITOR ATO MODEL · Class 2

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840682124331), received between Apr 23, 2025 and Apr 23, 2025 — classified as 1 death.

The most frequently reported specific device problem is “Defective 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.

Reports received per month

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

Most reported problems

Device problems

Defective Alarm1

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.

DeathApr 23, 2025Defective Alarm; Defective Alarm
WHILE BEING USED TO MONITOR A PATIENT DURING TRANSPORT, THE BATTERY FAILED AND THE MONITOR SHUT DOWN. IT WAS ALLEGED THAT THE MONITOR DID NOT ALARM FOR LOW BATTERY. THE PATIENT EXPIRED.
Patient problems: Insufficient Information
MAUDE report 21894108 ↗

Device details

UDI-DI	`00840682124331`
Brand	N/A
Model	B125 Patient Monitor
Company	Ge Medical Systems Information Technologies, Inc.
Product code	NHP · Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	Not in Commercial Distribution
Record updated	Apr 17, 2025

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.

Other Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration) devices

CARESCAPE B650 MBB313
GE Healthcare Finland Oy · Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)
1 recall0 reports

All Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration) 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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