BeneVision N19 Patient MonitorRecalls & reported problems
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 1
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 06944904095608), received between Nov 18, 2025 and Nov 20, 2025 — classified as 1 death, 2 injuries.
The most frequently reported specific device problem is “No Audible 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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- No Audible Alarm1
Patient problems
- Cardiac Arrest2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
DeathNov 20, 2025No Audible Alarm; No Audible Alarm
ON (B)(6) 2025, AT 1:24 AM, A PATIENT IN THE INTENSIVE CARE UNIT (ICU) WAS CONNECTED TO A BENEVISION N19 PATIENT MONITOR (SERIAL NUMBER: (B)(6)) AND A BENEVISION WORKSTATION (SERIAL NUMBER: (B)(6)). DURING THIS TIME, THE PATIENT "CODED". IT WAS REPORTED THAT NO AUDIBLE ALARMS, SPECIFICALLY ECG-RELATED ALARMS, WERE HEARD IN THE PATIENT'S ROOM OR AT THE NURSE'S STATION. THE PATIENT EXPERIENCED A SECOND CODING AT 1:48 AM AND SUBSEQUENTLY EXPIRED.
Patient problems: Insufficient Information
MAUDE report 23611136 ↗InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO DEVICE MALFUNCTION WAS REPORTED. THE CUSTOMER HAS REQUESTED THAT MINDRAY CONDUCT A LOG EVALUATION FOR AN EVENT THAT OCCURRED ON (B)(6) 2025, BETWEEN 4:00 PM AND 7:00 PM WITH THE BENEVISION N19 PATIENT MONITOR (SERIAL NUMBER: (B)(6)). THE CUSTOMER SEEKS CLARIFICATION REGARDING WHETHER ALL ALARMS DURING THE SPECIFIED PERIOD WERE RELATED AND WHETHER ANY DEVICE SETTINGS OR PARAMETERS WERE CHANGED PRIOR TO THE PATIENT CODING. ON (B)(6) 2025, MINDRAY WAS NOTIFIED THAT THE PATIENT ASSOCIATED WITH THIS OCCURRENCE CODED. FURTHERMORE, IT WAS CLARIFIED THAT THE PATIENT HAD EXPERIENCED AN ARREST.
Patient problems: Cardiac Arrest
MAUDE report 23587364 ↗InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO DEVICE MALFUNCTION WAS REPORTED. THE CUSTOMER HAS REQUESTED THAT MINDRAY CONDUCT A LOG EVALUATION FOR AN EVENT THAT OCCURRED ON (B)(6) 2025, BETWEEN 4:00 PM AND 7:00 PM WITH THE BENEVISION N19 PATIENT MONITOR (SERIAL NUMBER: (B)(6). THE CUSTOMER SEEKS CLARIFICATION REGARDING WHETHER ALL ALARMS DURING THE SPECIFIED PERIOD WERE RELATED AND WHETHER ANY DEVICE SETTINGS OR PARAMETERS WERE CHANGED PRIOR TO THE PATIENT CODING. ON (B)(6) 2025, MINDRAY WAS NOTIFIED THAT THE PATIENT ASSOCIATED WITH THIS OCCURRENCE CODED. FURTHERMORE, IT WAS CLARIFIED THAT THE PATIENT HAD EXPERIENCED AN ARREST.
Patient problems: Cardiac Arrest
MAUDE report 23587350 ↗
Other Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) devices
- IntelliVue MX40 1.4GHz MX40 1.4 GHz Smart HoppingPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall47 deaths2,541 reports
- NA PU-621RNihon Kohden Corporation · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)17 deaths1,666 reports
- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)7 recalls8 deaths1,217 reports
- NA PU-681RANihon Kohden Corporation · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)22 deaths1,493 reports
- IntelliVue Multi-Measurement Module X3 IntelliVue X3Philips Medizin Systeme Böblingen GmbH · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall19 deaths1,172 reports
- Patient Information Center IXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)82 deaths941 reports
- Patient Information Center iXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)83 deaths814 reports
- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)5 recalls541 reports
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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