BeneVision N12 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06944904095592), received between Dec 10, 2025 and Dec 10, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (2 reports).
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
- Device Alarm System2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2025Device Alarm System; Device Alarm System
PER MEDWATCH REPORT REFERENCE # MW5177989: NURSE WAS GOING THROUGH EVENT LOGS TO PRINT OFF A STRIP FROM THE PATIENT'S RECORDS. WHILE GOING THROUGH THE RECORDS, A RUN OF PREMATURE VENTRICULAR COMPLEXES (PVCS) WERE FOUND AT A TACHYCARDIC RATE AND THERE WAS NO HIGHLIGHTING OF THAT TRACE TO INDICATE ANY ALARMS. THERE WAS ALSO NO CHANGE IN CALCULATED HEART RATE. THERE WERE NO ALARMS THAT SOUNDED AT THE TIME OF EVENT. FROM THE ATTACHED IMAGE OF THE STRIP, IT IS EVIDENT THAT THERE WAS A VENTRICULAR TACHYCARDIA (V-TACH) EVENT. AFTER THIS WAS FOUND, STAFF GOT BIOMED INVOLVED TO DO AN INVESTIGATION. FROM BIOMED'S FINDINGS, THE MULTIPARAMETER MODULE (MPM) MODULE THAT WAS IN THE NEMESIS PRIME (N12) MONITOR WAS UNABLE TO ANNOTATE THE QRS COMPLEX. THE COMPATIBILITY ISSUE IS BELIEVED TO BE WHY THERE WAS NO ALARM. MEANWHILE, THE PATIENT WAS MOVED TO A DIFFERENT ROOM WITH A NEW N12 AND N1 MODULE CONNECTED AND THERE WAS A V-TACH ALARM FOR A SIMILAR RUN OF PVCS. MINDRAY WAS CALLED AND CREATED AN INVESTIGATION OF THEIR OWN. THEIR INITIAL FINDINGS WERE THAT THE MONITOR WAS CORRECT IN ITS CALCULATIONS AND THE WAVEFORM FROM THE INCIDENT DID NOT MEET THE REQUIREMENTS TO TRIGGER A V-TACH ALARM. THERE HAS N
Patient problems: Insufficient Information
MAUDE report 23768211 ↗MalfunctionDec 10, 2025Device Alarm System; Device Alarm System
PER MEDWATCH REPORT REFERENCE # MW5177989: NURSE WAS GOING THROUGH EVENT LOGS TO PRINT OFF A STRIP FROM THE PATIENT'S RECORDS. WHILE GOING THROUGH THE RECORDS, A RUN OF PREMATURE VENTRICULAR COMPLEXES (PVCS) WERE FOUND AT A TACHYCARDIC RATE AND THERE WAS NO HIGHLIGHTING OF THAT TRACE TO INDICATE ANY ALARMS. THERE WAS ALSO NO CHANGE IN CALCULATED HEART RATE. THERE WERE NO ALARMS THAT SOUNDED AT THE TIME OF EVENT. FROM THE ATTACHED IMAGE OF THE STRIP, IT IS EVIDENT THAT THERE WAS A VENTRICULAR TACHYCARDIA (V-TACH) EVENT. AFTER THIS WAS FOUND, STAFF GOT BIOMED INVOLVED TO DO AN INVESTIGATION. FROM BIOMED'S FINDINGS, THE MULTIPARAMETER MODULE (MPM) MODULE THAT WAS IN THE NEMESIS PRIME (N12) MONITOR WAS UNABLE TO ANNOTATE THE QRS COMPLEX. THE COMPATIBILITY ISSUE IS BELIEVED TO BE WHY THERE WAS NO ALARM. MEANWHILE, THE PATIENT WAS MOVED TO A DIFFERENT ROOM WITH A NEW N12 AND N1 MODULE CONNECTED AND THERE WAS A V-TACH ALARM FOR A SIMILAR RUN OF PVCS. MINDRAY WAS CALLED AND CREATED AN INVESTIGATION OF THEIR OWN. THEIR INITIAL FINDINGS WERE THAT THE MONITOR WAS CORRECT IN ITS CALCULATIONS AND THE WAVEFORM FROM THE INCIDENT DID NOT MEET THE REQUIREMENTS TO TRIGGER A V-TACH ALARM. THERE HAS N
Patient problems: Insufficient Information
MAUDE report 23768201 ↗
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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