MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD BENEVISION N1 PATIENT MONITOR

Model Number	N1
Medical Device Problem Codes	Device Alarm System (1012); No Audible Alarm (1019); Alarm Not Visible (1022)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	07/07/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Narrative mindray representatives tested the operation of all benevision n12 and n1 monitors in the department.The devices are functioning normally, and no alarm failure phenomenon was found.More monitor logs are being collected for investigation, and this issue is under investigation.
Event or Problem Description
It was reported that on (b)(6) 2025, at 10:00 p.M., a patient was connected to a benevision n12 patient monitor (serial number: (b)(6) in use with a benevision n1 (serial number: (b)(6).The patient experienced asystole; however, no alarm was generated.
Event or Problem Description
It was reported that on july 7, 2025, at 10:00 p.M., a patient was connected to a benevision n12 patient monitor (serial number (b)(6)) in use with a benevision n1 (serial number (b)(6)).The patient experienced asystole; however, no alarm was generated.
Additional Manufacturer Narrative
When the benevision n1 patient monitor is used as a module with other mindray monitors, there is a low probability that upon setting an alarm pause, the device may remain in the alarm pause state without displaying the remaining alarm pause time.In this situation, a prompt indicating the alarm pause state will remain visible on the interface, and all other monitoring functions and technical alarm functions will continue to operate normally.Users can cancel the alarm pause at any time.Mindray will issue a field safety notice (fsn) to affected customers informing them of the relevant information and the measures taken.Mindray service team representative or authorized service personnel will contact customers for software upgrade.

• Brand Name: BENEVISION N1 PATIENT MONITOR
• Common Device Name: BENEVISION N1
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; 1203 nanhuan avenue; guangming district; shenzhen, guangming 51810 6; CH 518106
• Manufacturer Contact: jessica edwards ; 800 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 22664532
• Report Number: 3009156722-2025-00016
• Device Sequence Number: 18004508
• Product Code: MHX
• UDI-Device Identifier: 06944904094922
• UDI-Public: 06944904094922
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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: N1
• Device Catalogue Number: 6660B-PA00090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 97437
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown