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

Model Number	N1 PATIENT MONITOR
Medical Device Problem Codes	Device Alarm System (1012); No Audible Alarm (1019)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/25/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
The investigation is ongoing, pending additional information from the customer and review of event logs.
Event or Problem Description
The customer reported that a patient was connected to spo2 and the ecg displayed "leads off" as the patient was moving too much.Ecg alarm was missed and the patient was found unresponsive and cpr was initiated.Resuscitation efforts were not successful and the patient expired on (b)(6) 2024 at 2:30am.
Additional Manufacturer Narrative
The mindray field service representative verified the proper operation of benevision n1 (serial number (b)(6)).System logs of patient databases, device ip addresses, and room numbers were collected for analysis, and no malfunction was confirmed.The patient monitor was generating ecg technical alarms, indicating that the ecg leads were not connected to the patient.In addition, it alarmed when ecg waveforms were unavailable.These alarms are consistent with the event description, which stated that the patient was moving too much.According to the benevision n series patient monitor operator's manual (part number 046-011259-00) alarms table, the recommendation is that after the device alarms for ecg lead-off, the user needs to check the connection of the electrodes and lead wires.Mindray benevision n1 performed per specifications.
Event or Problem Description
The customer reported that a patient was connected to spo2 and the ecg displayed "leads off" as the patient was moving too much.Ecg alarm was missed and the patient was found unresponsive and cpr was initiated.Resuscitation efforts were not successful and the patient expired on (b)(6) 2024 at 2:30am.
Event or Problem Description
The customer reported that a patient was connected to spo2 and the ecg displayed "leads off" as the patient was moving too much.Ecg alarm was missed and the patient was found unresponsive and cpr was initiated.Resuscitation efforts were not successful and the patient expired on (b)(6) 2024 at 2:30am.
Additional Manufacturer Narrative
The mindray field service representative verified the proper operation of benevision n1 (serial number (b)(6)).System logs of patient databases, device ip addresses, and room numbers were collected for analysis, and no malfunction was confirmed.The patient monitor was generating ecg technical alarms, indicating that the ecg leads were not connected to the patient.In addition, it alarmed when ecg waveforms were unavailable.These alarms are consistent with the event description, which stated that the patient was moving too much.According to the benevision n series patient monitor operator's manual (part number 046-011259-00) alarms table, the recommendation is that after the device alarms for ecg lead-off, the user needs to check the connection of the electrodes and lead wires.Mindray benevision n1 performed per specifications.Correction: b2 and b3 (correcting the year date) and d4 (correction of the udi).

• 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: sonia vale ; 800 macarthur blvd.; mahwah, NJ 07430 ; 2019958643
• MDR Report Key: 20997804
• Report Number: 3009156722-2024-00021
• Device Sequence Number: 15122806
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2025

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: N1 PATIENT MONITOR
• Device Catalogue Number: 6660E-PA00012
• 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: 11/25/2024
• Supplement Date Received by Manufacturer: 03/31/2025; 12/03/2025
• Initial Report FDA Received Date: 12/22/2024
• Supplement Report FDA Received Date: 04/10/2025; 12/03/2025
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown