BeneVision N1 Patient monitorRecalls & reported problems

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Class 2

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 7
Deaths reported: 3
Injuries reported: 2
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 06944904094922), received between Oct 4, 2024 and Sep 26, 2025 — classified as 3 deaths, 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

Aug 15, 2025Class IIOpen, Classified
Potential for activation of an abnormal alarm pause.
Z-2622-2025 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Device problems

Device Alarm System5
No Audible Alarm5
Failure to Deflate2
Alarm Not Visible1
Protective Measures Problem1

Patient problems

Insufficient Information4
Ecchymosis2
Ischemia2
Neuropathy2
Thrombosis/Thrombus2
Asystole1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

InjurySep 26, 2025Failure to Deflate; Failure to Deflate
ON (B)(6) 2025, DURING A SURGICAL PROCEDURE BEGINNING AT 07:30 AM AND ENDING AT 11:22 AM, THE BLOOD PRESSURE CUFF REMAINED INFLATED FOR A PERIOD EXCEEDING THREE HOURS. ON (B)(6) 2025, THE CUSTOMER ADDITIONALLY REPORTED THE PATIENT'S ARM WAS TUCKED AND INACCESSIBLE. THE ARTERIAL LINE WAS PLACED IN THE CONTRALATERAL ARM AND PROVIDED RELIABLE BLOOD PRESSURE READINGS. THE BLOOD PRESSURE CUFF WAS REMOVED FROM THE PATIENT. THE PATIENT EXPERIENCED ISCHEMIA OF THE UPPER EXTREMITY FOR APPROXIMATELY THREE HOURS, INCLUDED DEEP VEIN THROMBOSIS (DVT) IN THE ARM VEINS, SKIN DISCOLORATION, AND NEUROPATHY.
Patient problems: Ecchymosis; Ischemia; Neuropathy; Thrombosis/Thrombus
MAUDE report 23156387 ↗
InjurySep 26, 2025Failure to Deflate; Failure to Deflate
ON (B)(6) 2025, DURING A SURGICAL PROCEDURE BEGINNING AT 07:30 AM AND ENDING AT 11:22 AM, THE BLOOD PRESSURE CUFF REMAINED INFLATED FOR A PERIOD EXCEEDING THREE HOURS. ON SEPTEMBER 18, 2025, THE CUSTOMER ADDITIONALLY REPORTED THE PATIENT'S ARM WAS TUCKED AND INACCESSIBLE. THE ARTERIAL LINE WAS PLACED IN THE CONTRALATERAL ARM AND PROVIDED RELIABLE BLOOD PRESSURE READINGS. THE BLOOD PRESSURE CUFF WAS REMOVED FROM THE PATIENT. THE PATIENT EXPERIENCED ISCHEMIA OF THE UPPER EXTREMITY FOR APPROXIMATELY THREE HOURS, INCLUDED DEEP VEIN THROMBOSIS (DVT) IN THE ARM VEINS, SKIN DISCOLORATION, AND NEUROPATHY.
Patient problems: Ecchymosis; Ischemia; Neuropathy; Thrombosis/Thrombus
MAUDE report 23156368 ↗
DeathJul 30, 2025Device Alarm System; No Audible Alarm; Alarm Not Visible; Device Alarm System; No Audible Alarm; Alarm Not Visible
IT WAS REPORTED THAT ON JULY 7, 2025, AT 10:00 P.M., A PATIENT WAS CONNECTED TO A BENEVISION N12 PATIENT MONITOR (SERIAL NUMBER (B)(6)) IN USE WITH A BENEVISION N1 (SERIAL NUMBER (B)(6)). THE PATIENT EXPERIENCED ASYSTOLE; HOWEVER, NO ALARM WAS GENERATED.
Patient problems: Asystole
MAUDE report 22664532 ↗
DeathDec 22, 2024Device Alarm System; No Audible Alarm; Protective Measures Problem; Device Alarm System; No Audible Alarm; Protective Measures Problem
THE CUSTOMER REPORTED THAT A PATIENT WAS CONNECTED TO SPO2 AND THE ECG DISPLAYED "LEADS OFF" AS THE PATIENT WAS MOVING TOO MUCH. ECG ALARM WAS MISSED AND THE PATIENT WAS FOUND UNRESPONSIVE AND CPR WAS INITIATED. RESUSCITATION EFFORTS WERE NOT SUCCESSFUL AND THE PATIENT EXPIRED ON (B)(6) 2024 AT 2:30AM.
Patient problems: Insufficient Information
MAUDE report 20997805 ↗
DeathDec 22, 2024Device Alarm System; No Audible Alarm; Device Alarm System; No Audible Alarm
THE CUSTOMER REPORTED THAT A PATIENT WAS CONNECTED TO SPO2 AND THE ECG DISPLAYED "LEADS OFF" AS THE PATIENT WAS MOVING TOO MUCH. ECG ALARM WAS MISSED AND THE PATIENT WAS FOUND UNRESPONSIVE AND CPR WAS INITIATED. RESUSCITATION EFFORTS WERE NOT SUCCESSFUL AND THE PATIENT EXPIRED ON (B)(6) 2024 AT 2:30AM.
Patient problems: Insufficient Information
MAUDE report 20997804 ↗
MalfunctionOct 4, 2024Device Alarm System; No Audible Alarm; Device Alarm System; No Audible Alarm
IT WAS REPORTED THAT ON (B)(6) 2024, AT 10:54 P.M., THE BENEVISION N1 PATIENT MONITOR DID NOT GENERATE A LOW SPO2 AUDIO ALARM. NO PATIENT INJURY WAS REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20376024 ↗
MalfunctionOct 4, 2024Device Alarm System; No Audible Alarm; Device Alarm System; No Audible Alarm
IT WAS REPORTED THAT ON (B)(6) 2024, AT 10:54 P.M., THE BENEVISION N1 PATIENT MONITOR DID NOT GENERATE A LOW SPO2 AUDIO ALARM. NO PATIENT INJURY WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 20373686 ↗

Device details

UDI-DI	`06944904094922`
Brand	BeneVision N1 Patient monitor
Model	BeneVision N1
Company	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Product code	MHX · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Jan 21, 2026

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 Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) devices

IntelliVue MX40 1.4GHz MX40 1.4 GHz Smart Hopping
Philips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
1 recall47 deaths2,541 reports
NA PU-621R
Nihon Kohden Corporation · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
17 deaths1,666 reports
Tempus Pro 00-1024-R
Remote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
7 recalls8 deaths1,217 reports
NA PU-681RA
Nihon Kohden Corporation · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
22 deaths1,493 reports
IntelliVue Multi-Measurement Module X3 IntelliVue X3
Philips Medizin Systeme Böblingen GmbH · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
1 recall19 deaths1,172 reports
Patient Information Center IX
Philips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
82 deaths941 reports
Patient Information Center iX
Philips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
83 deaths814 reports
Tempus Pro 00-1024-R
Remote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
5 recalls541 reports

All Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) 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 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page