BeneVision N17 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
- 2
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06944904095578), received between Mar 20, 2025 and Mar 20, 2025 — classified as 2 deaths.
The most frequently reported specific device problem is “No Visual Prompts/Feedback” (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
- Adverse Event Without Identified Device or Use Problem2
- No Visual Prompts/Feedback2
- Output Problem2
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.
DeathMar 20, 2025Adverse Event Without Identified Device or Use Problem; Output Problem; No Visual Prompts/Feedback; Adverse Event Without Identified Device or Use Problem; Output Problem; No Visual Prompts/Feedback
DURING AN INVESTIGATION FOLLOW-UP ON APRIL 7, 2025, THE CUSTOMER CLARIFIED THE INVESTIGATION REQUEST. NO ALLEGED MALFUNCTION WAS REPORTED. THE CUSTOMER IS REQUESTING THE KEYSTROKE FOR THE A7 ANESTHESIA MACHINE (SERIAL NUMBER (B)(6)) AND THE BENEVISION N17 PATIENT MONITOR (SERIAL NUMBER (B)(6)). THE REQUEST IS FOR RAW DATA FROM 09:00 AM TO 11:00 AM ON (B)(6) 2025. SOME VENTILATION CHANGES WERE MADE TO THE ANESTHESIA MACHINE AT 10:28. THEREFORE, THE CUSTOMER REQUESTED TO PROVIDE DETAILS ON THE KEYSTROKE ACTIVITY ON THE ANESTHESIA MACHINE AND BEDSIDE MONITOR 10 MINUTES BEFORE AND 10 MINUTES AFTER THAT TIME. THE PATIENT EXPIRED DAYS AFTER (B)(6) 2025 (THE EXACT DATE IS UNKNOWN).
Patient problems: Insufficient Information
MAUDE report 21654746 ↗DeathMar 20, 2025Adverse Event Without Identified Device or Use Problem; Output Problem; No Visual Prompts/Feedback; Adverse Event Without Identified Device or Use Problem; Output Problem; No Visual Prompts/Feedback
DURING AN INVESTIGATION FOLLOW-UP ON APRIL 7, 2025, THE CUSTOMER CLARIFIED THE INVESTIGATION REQUEST. NO ALLEGED MALFUNCTION WAS REPORTED. THE CUSTOMER IS REQUESTING THE KEYSTROKE FOR THE A7 ANESTHESIA MACHINE (SERIAL NUMBER (B)(6)) AND THE BENEVISION N17 PATIENT MONITOR (SERIAL NUMBER (B)(6)). THE REQUEST IS FOR RAW DATA FROM 09:00 AM TO 11:00 AM ON (B)(6) 2025. SOME VENTILATION CHANGES WERE MADE TO THE ANESTHESIA MACHINE AT 10:28. THEREFORE, THE CUSTOMER REQUESTED TO PROVIDE DETAILS ON THE KEYSTROKE ACTIVITY ON THE ANESTHESIA MACHINE AND BEDSIDE MONITOR 10 MINUTES BEFORE AND 10 MINUTES AFTER THAT TIME. THE PATIENT EXPIRED DAYS AFTER (B)(6) 2025 (THE EXACT DATE IS UNKNOWN).
Patient problems: Insufficient Information
MAUDE report 21654703 ↗
Other Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) devices
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- 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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