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

Model Number	BENEVISION N1
Medical Device Problem Codes	Device Alarm System (1012); No Audible Alarm (1019)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A mindray field service representative verified the proper operation of the benevision n1, the audio alarms were generated during simulation testing.Patient monitor logs were collected for investigation.The occurrence is under investigation.
Event or Problem Description
It was reported that on (b)(6) 2024, at 10:54 p.M., the benevision n1 patient monitor did not generate a low spo2 audio alarm.No patient injury was reported.
Additional Manufacturer Narrative
A mindray field service representative verified the proper operation of the benevision n1, the audio alarms were generated during simulation testing.Patient monitor logs were collected for investigation.The occurrence is under investigation.
Event or Problem Description
It was reported that on (b)(6) 2024, at 9:55 p.M., the benevision n1 patient monitor did not generate a low spo2 audio alarm.No patient injury was reported.
Additional Manufacturer Narrative
Mindray conducted a comprehensive analysis of the device logs and verified that no alarms were generated for low spo2 at the reported occurrence time.The benevision n1 patient monitor (n1) records indicated non-invasive blood pressure (nibp) cuff inflation activity immediately before and after the occurrence.Consequently, the monitor was returned to mindray for further log collection and extensive evaluation of the parameter boards (m51c5l-fe, 3-spo2, ibp, and ao(n1)/051-002832-00).The investigation determined that the most probable cause of the occurrence was a blockage in the nibp hose, which activated the n1 monitor's overpressure protection feature.In this state, the n1 software interprets that there is presence of pressure in the cuff and automatically engages the nibp simul function.When this function is active, any detected low spo2 value is attributed to the ongoing nibp measurement.As a result, the software does not generate low spo2 alarm.No device malfunction was identified; the n1 monitor operated per specifications.
Event or Problem Description
It was reported that on (b)(6) 2024, at 9:55 p.M., the benevision n1 patient monitor did not generate a low spo2 audio alarm.No patient injury was reported.

• Brand Name: BENEVISION N1 PATIENT MONITOR
• Common Device Name: N1 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: 20373686
• Report Number: 3009156722-2024-00013
• Device Sequence Number: 6925513
• Product Code: MHX
• UDI-Device Identifier: 06944904094922
• UDI-Public: 06944904094922
• 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,Followup
• Report Date (Section B): 11/24/2025

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
• Operator of Device: Health Professional
• Device Model Number: BENEVISION N1
• Device Catalogue Number: 6660E-PA00011
• 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: 09/06/2024
• Supplement Date Received by Manufacturer: 10/14/2024; 11/07/2025
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/11/2024; 11/24/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown