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

Model Number	N19
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
No device malfunction was reported.The customer has requested that mindray conduct a log evaluation for an event that occurred on october 6, 2025, between 4:00 pm and 7:00 pm with benevision n19 patient monitor (serial number: (b)(6).The customer seeks clarification regarding whether all alarms during the specified period were related and whether any device settings or parameters were changed prior to the patient coding.On (b)(6) 2025, mindray was notified that the patient associated with this occurrence coded.Furthermore, it was clarified that the patient had experienced an arrest.
Additional Manufacturer Narrative
Logs were collected for evaluation, and the occurrence is under investigation.
Additional Manufacturer Narrative
Mindray collected logs from the benevision n19 patient monitor (serial number: (b)(6)) for evaluation.Mindray's investigation confirmed that prior to 4:00 pm on (b)(6) 2025, only the on/off setting of the ibp art alarm had been modified.Additionally, the lower limit of the hr alarm was adjusted on (b)(6) 2025.No other alarm settings were changed during the period in question.During the specified timeframe, multiple physiological alarms were generated, including rr high, spo2 desaturation, extreme bradycardia, spo2 no signal, ventricular tachycardia, and tachycardia alarms.The benevision n19 patient monitor performed per specifications.
Event or Problem Description
No device malfunction was reported.The customer has requested that mindray conduct a log evaluation for an event that occurred on (b)(6) 2025, between 4:00 pm and 7:00 pm with the benevision n19 patient monitor (serial number: (b)(6)).The customer seeks clarification regarding whether all alarms during the specified period were related and whether any device settings or parameters were changed prior to the patient coding.On (b)(6) 2025, mindray was notified that the patient associated with this occurrence coded.Furthermore, it was clarified that the patient had experienced an arrest.

• 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: 23587364
• Report Number: 3009156722-2025-00020
• Device Sequence Number: 18491361
• Product Code: MHX
• UDI-Device Identifier: 06944904095608
• UDI-Public: 06944904095608
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 12/23/2025

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?: No
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Other
• Patient Sex: Unknown