MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD BENEVISION N17 PATIENT MONITOR

Model Number	BENEVISION N17 PATIENT MONITOR
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005); No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/29/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
A mindray field service representative collected the patient database, and the benevision n17 monitor logs for investigation.The log analysis shows the following: the n17 was set to standby mode at 15:28 on (b)(6) 2025 and exited standby mode at 7:39 on (b)(6) 2025.In standby mode, the monitor stops all parameter measurements and disables all alarm indications.In conclusion, there is no patient data for (b)(6) 2025, because the n17 was in standby mode.Benevision n17 performed according to specifications, no product malfunction occurred.
Event or Problem Description
The user reported being unable to see patient discharge data for (b)(6) 2025, on benevision n17 (serial number (b)(6).The user was able to see data on (b)(6) 2025, and (b)(6) 2025.The patient expired.
Additional Manufacturer Narrative
A mindray field service representative collected the patient database, and the benevision n17 monitor logs for investigation.The log analysis shows the following: the n17 was set to standby mode at 15:28 on (b)(6) 2025 and exited standby mode at 7:39 on (b)(6) 2025.In standby mode, the monitor stops all parameter measurements and disables all alarm indications.In conclusion, there is no patient data for (b)(6) 2025, because the n17 was in standby mode.Benevision n17 performed according to specifications, no product malfunction occurred.
Event or Problem Description
The user reported being unable to see patient discharge data for (b)(6) 2025, on benevision n17 (serial number (b)(6)).The user was able to see data on (b)(6) 2025, and (b)(6) 2025.The patient expired days after the (b)(6) 2025 (the exact date is unknown).
Additional Manufacturer Narrative
A mindray field service representative collected the patient database and the benevision n17 monitor logs for review.Mindray provided the benevision n17 keystroke activity for the required period.A mindray service representative, upon clarifying the request, returned to the site to collect logs from the anesthesia unit.However, since the attempt to collect data was on (b)(6) 2025, the data for the occurrence date ((b)(6) 2025) is no longer available on the a-series.No device malfunction was reported with the mindray devices.Units are monitored per specifications.
Event or Problem Description
During an investigation follow-up on april 7, 2025, the customer clarified the investigation request.No alleged malfunction was reported.The customer is requesting the keystroke for the a7 anesthesia machine (serial number (b)(6)) and the benevision n17 patient monitor (serial number (b)(6)).The request is for raw data from 09:00 am to 11:00 am on (b)(6) 2025.Some ventilation changes were made to the anesthesia machine at 10:28.Therefore, the customer requested to provide details on the keystroke activity on the anesthesia machine and bedside monitor 10 minutes before and 10 minutes after that time.The patient expired days after (b)(6) 2025 (the exact date is unknown).

• Brand Name: BENEVISION N17 PATIENT MONITOR
• Common Device Name: BENEVISION N17
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; 1203 nanhuan avenue; guangming district; shenzhen, guangming 51810 6; CH 518106
• Manufacturer Contact: sonia vale ; 800 macarthur blvd.; mahwah 07430 ; 2013123286
• MDR Report Key: 21654703
• Report Number: 3009156722-2025-00005
• Device Sequence Number: 7536539
• Product Code: MHX
• UDI-Device Identifier: 06944904095578
• UDI-Public: 06944904095578
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2025

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
• Operator of Device: Health Professional
• Device Model Number: BENEVISION N17 PATIENT MONITOR
• Device Catalogue Number: 6610E-PA00004
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: 04/15/2025; 04/07/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/18/2025; 05/07/2025
• 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: Death
• Patient Sex: Unknown