MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD BENEVISION N12 PATIENT MONITOR

Model Number	BENEVISION N12
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The benevision n12 patient monitor (serial number: (b)(6) was being used with an mpm (serial number: (b)(6).Mindray tested the units involved and could not duplicate the issue.Logs data from the monitor, central station, and patient database were collected and reviewed.It was determined that the heart rate calculation function operated per device specifications, the incident did not meet the requirements to trigger a v-tach alarm.No malfunction was identified.Upon receipt of medwatch report # mw5177989, mindray made good faith efforts to obtain additional details from the facility to clarify the rationale for classifying the occurrence as "required intervention" and "serious injury." no further information was provided, and no patient injury was confirmed.
Event or Problem Description
Per medwatch report reference # mw5177989: nurse was going through event logs to print off a strip from the patient's records.While going through the records, a run of premature ventricular complexes (pvcs) were found at a tachycardic rate and there was no highlighting of that trace to indicate any alarms.There was also no change in calculated heart rate.There were no alarms that sounded at the time of event.From the attached image of the strip, it is evident that there was a ventricular tachycardia (v-tach) event.After this was found, staff got biomed involved to do an investigation.From biomed's findings, the multiparameter module (mpm) module that was in the nemesis prime (n12) monitor was unable to annotate the qrs complex.The compatibility issue is believed to be why there was no alarm.Meanwhile, the patient was moved to a different room with a new n12 and n1 module connected and there was a v-tach alarm for a similar run of pvcs.Mindray was called and created an investigation of their own.Their initial findings were that the monitor was correct in its calculations and the waveform from the incident did not meet the requirements to trigger a v-tach alarm.There has not been any mention of the mpm not being compatible with the n12 monitor.This voluntary report is being submitted primarily so that other hospitals with mindray n-series monitors and mpm modules can be made aware of this event.

• Brand Name: BENEVISION N12 PATIENT MONITOR
• Common Device Name: N12 PATIENT MONITOR
• 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: anna jeczen ; 800 macarthur blvd; mahwah, NJ 07430 ; 2019958096
• MDR Report Key: 23768211
• Report Number: 3009156722-2025-00022
• Device Sequence Number: 16110036
• Product Code: MHX
• UDI-Device Identifier: 06944904095592
• UDI-Public: 06944904095592
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K213799
• 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): 12/10/2025

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 N12
• Device Catalogue Number: 6630E-PA00002
• 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: 11/14/2025
• Initial Report FDA Received Date: 12/10/2025
• 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 Age: 42 YR
• Patient Sex: Male
• Patient Race: White