MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD BENEVISION DISTRIBUTED MONITORING SYSTEM (DMS); BENEVISION CENTRAL STATION

Model Number	BENEVISION CS
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	01/25/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Mindray conducted an investigation that included functional testing of the tm80 telemetry unit using a patient simulator and a review of event history logs from the tm80 telemetry unit and the associated benevision distributed monitoring system (dms) workstation, as well as available patient database information.Functional testing confirmed that the tm80 generated the appropriate alarms when simulated conditions were applied.A review of the central station, workstation, and tm80 telemetry logs demonstrated that an ecg lead disconnection alarm occurred during the reported complaint period.No cardiac rhythm alarms were generated during this time, consistent with the patient not being connected to ecg leads.The log review identified no alarm reset or alarm acknowledgment operations during the reported time frame.The sequence of events documented in the logs was consistent with the customer's report.The tm80 telemetry unit in use with benevision dms performed per specifications.
Event or Problem Description
No device malfunction was reported by the customer.It was reported that between (b)(6) 2026, at approximately 23:30 and (b)(6) 2026, at approximately 01:00, a patient connected to a tm80 unit and subsequently connected to a benevision distributed monitoring system (dms) workstation expired while not connected to ecg leads.During this time period, the patient had removed the ecg leads.As a result, a "patient disconnected from ecg" alarm was present, and no cardiac rhythm alarms were generated.Clinical staff were unable to acknowledge/silence alarms from workstation due to prior event.

• Brand Name: BENEVISION DISTRIBUTED MONITORING SYSTEM (DMS)
• Common Device Name: BENEVISION CENTRAL STATION
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; 1203 nanhuan avenue; guangming district; shenzhen, guangming 51810 6; CH 518106
• Manufacturer (Section G): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; 1203 nanhuan avenue; guangming district; shenzhen, guangming 51810 6; CH 518106
• Manufacturer Contact: summer nawaz ; 800 macarthur blvd; mahwah, NJ 07430 ; 2019958052
• MDR Report Key: 24446328
• Report Number: 3009156722-2026-00004
• Device Sequence Number: 10364644
• Product Code: MSX
• UDI-Device Identifier: 06936415972417
• UDI-Public: 06936415972417
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K242728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 02/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: BENEVISION CS
• Device Catalogue Number: 115-053154-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown