MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD BENEVISION N19; N19 PATIENT MONITOR

Model Number	N19
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/21/2025
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2025, at 1:24 am, a patient in the intensive care unit (icu) was connected to a benevision n19 patient monitor (serial number: (b)(6)) and a benevision workstation (serial number: (b)(6)).During this time, the patient "coded".It was reported that no audible alarms, specifically ecg-related alarms, were heard in the patient's room or at the nurse's station.The patient experienced a second coding at 1:48 am and subsequently expired.
Additional Manufacturer Narrative
A mindray service representative conducted an on-site evaluation of the benevision n19 patient monitor and the associated workstation.The representative was unable to replicate the reported issue.Device logs from the benevision n19 patient monitor, central station server, and workstation were collected for further analysis.Review of the device and server logs confirmed that, at the times of the reported events (1:24 am and 1:48 am), the following arrhythmia alarms were generated: ventricular tachycardia (v-tach), ventricular fibrillation (v-fib)/v-tach, and extreme tachycardia (extreme tachy).The logs further confirmed that, at the corresponding alarm times, the audible alarms were activated on both the n19 patient monitor and the benevision workstation.Both devices performed according to specifications.High-priority arrhythmia alarms were triggered as expected, and log records indicate that audible alarms played normally.The benevision n19 patient monitor and benevision workstation performed per specifications.

• Brand Name: BENEVISION N19
• Common Device Name: N19 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: 23611136
• Report Number: 3009156722-2025-00021
• Device Sequence Number: 21278441
• Product Code: MHX
• UDI-Device Identifier: 06944904095608
• UDI-Public: 06944904095608
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 11/20/2025

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?: Yes
• Device Model Number: N19
• 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: 10/24/2025
• Initial Report FDA Received Date: 11/20/2025
• 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