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 Codes	Device Alarm System (1012); No Audible Alarm (1019)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Case under investigation.
Event or Problem Description
It was reported that on (b)(6) 2025, a ventricular tachycardia (v-tach) alarm was missed; the system did not generate an alarm for v-tach.No patient injury was reported.
Additional Manufacturer Narrative
Mindray established good faith efforts (between june 9, 2025 and july 24, 2025) to obtain additional information about the occurrence, like time of occurrence, device ids, ecg strips for investigation.Without additional information, no further investigation can be done, and the alleged malfunction cannot be confirmed.
Event or Problem Description
It was reported that on (b)(6) 2025, a ventricular tachycardia (v-tach) alarm was missed; the system did not generate an alarm for v-tach.No patient injury was reported.

• 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
• MDR Report Key: 22197277
• Report Number: 2221819-2025-00008
• Device Sequence Number: 8562258
• Product Code: MSX
• UDI-Device Identifier: 06936415972417
• UDI-Public: 06936415972417
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025
• Report Date (Section F): 07/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: BENEVISION CS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/24/2025
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/25/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/25/2025