BeneVision Central Monitoring System (REF 115-034413-00)Recalls & reported problems
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Class 2
All models of BeneVision Central Monitoring System (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 06944904055152), received between Feb 11, 2021 and Feb 12, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (2 reports).
4 other recalls cover devices cleared under the same FDA submission (K150632, K242728); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- No Audible Alarm2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2021No Audible Alarm; No Audible Alarm
THE CUSTOMER REPORTED THAT AROUND 8:14AM ON (B)(6) 2021 A PATIENT WAS IN BRADYCARDIA AND NO AUDIBLE ALARM WAS HEARD AT THE BENEVISION DMS. A VISUAL ALARM WAS NOTED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11321147 ↗MalfunctionFeb 11, 2021No Audible Alarm; No Audible Alarm
THE CUSTOMER REPORTED THAT AROUND 8:14AM ON (B)(6) 2021 A PATIENT WAS IN BRADYCARDIA AND NO AUDIBLE ALARM WAS HEARD AT THE BENEVISION DMS. A VISUAL ALARM WAS NOTED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11318691 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K150632, K242728. One submission often covers many models, so check the product and lot details in each record.
- Z-0112-2027 · Aug 31, 2026 · Open, ClassifiedPanorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).
- Z-0111-2027 · Aug 31, 2026 · Open, ClassifiedBeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80
- Z-0554-2018 · Jul 14, 2017 · TerminatedTD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00
- Z-0321-2017 · Sep 8, 2016 · TerminatedTD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Industrial Partk, Nanshan, Shenzhen, 518057 P
Other System,Network And Communication,Physiological Monitors devices
- Xhibit Xhibit CentralSpacelabs Healthcare (Washington), Inc · System, network and communication, physiological monitors3 deaths218 reports
- Infinity M540 MS26372Draeger Medical Systems, Inc. · System,Network And Communication,Physiological Monitors2 recalls9 reports
- CareEventPhilips Medical Systems Hsg · System, network and communication, physiological monitors2 recalls4 deaths7 reports
- XTR 96280Spacelabs Healthcare (Washington), Inc · SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS2 recalls0 reports
- CNS-2101 Central MonitorNihon Kohden Corporation · System, Network And Communication, Physiological Monitors3 deaths76 reports
- BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · System, Network And Communication, Physiological Monitors1 recall2 deaths5 reports
- eCareManager 4.5Visicu, Inc. · System, network and communication, physiological monitors1 recall1 death1 report
- eCareManager 4.6Visicu, Inc. · System, network and communication, physiological monitors1 recall0 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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