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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, at 8:35am, the patient on a tm80 telemetry unit (tele id 55) was in ventricular tachycardia (v-tach) for 5 beats and the system did not generate a v-tach alarm.No patient injury was reported.
Additional Manufacturer Narrative
System logs were collected by mindray field service representative.Under investigation.
Additional Manufacturer Narrative
Mindray conducted a review of the benevision central station (cs) and tele 55 (tm80 telemetry) logs associated with the occurrence, and no malfunction was confirmed for any devices involved in the report.The reported widened qrs waves at the time of the occurrence are the regular ventricular-paced rhythm, which didn't meet the alarm thresholds.Mindray benevision cs with tm80 telemetry functioned according to specifications.
Event or Problem Description
It was reported that on (b)(6) 2025, at 8:35am, the patient on a tm80 telemetry unit (tele id 55) was in ventricular tachycardia (v-tach) for 5 beats and the system did not generate a v-tach alarm.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
• 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: 22197272
• Report Number: 3009156722-2025-00007
• Device Sequence Number: 8562256
• Product Code: MSX
• UDI-Device Identifier: 06936415972417
• UDI-Public: 06936415972417
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K220058
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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
• Device Catalogue Number: 115-051209-00
• 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: 05/17/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/29/2025
• 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
• Patient Sex: Unknown