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

Model Number	BENEVISION N1
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Codes	Ecchymosis (1818); Ischemia (1942); Neuropathy (1983); Thrombosis/Thrombus (4440)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The benevision n1 patient monitor (serial number (b)(6)) was returned to mindray for evaluation.Logs were collected for evaluation.The occurrence is under investigation.
Event or Problem Description
On (b)(6) 2025, during a surgical procedure beginning at 07:30 am and ending at 11:22 am, the blood pressure cuff remained inflated for a period exceeding three hours.On september 18, 2025, the customer additionally reported the patient's arm was tucked and inaccessible.The arterial line was placed in the contralateral arm and provided reliable blood pressure readings.The blood pressure cuff was removed from the patient.The patient experienced ischemia of the upper extremity for approximately three hours, included deep vein thrombosis (dvt) in the arm veins, skin discoloration, and neuropathy.
Event or Problem Description
On (b)(6) 2025, during a surgical procedure beginning at 07:30 am and ending at 11:22 am, the blood pressure cuff remained inflated for a period exceeding three hours.On (b)(6) 2025, the customer additionally reported the patient's arm was tucked and inaccessible.The arterial line was placed in the contralateral arm and provided reliable blood pressure readings.The blood pressure cuff was removed from the patient.The patient experienced ischemia of the upper extremity for approximately three hours, included deep vein thrombosis (dvt) in the arm veins, skin discoloration, and neuropathy.
Additional Manufacturer Narrative
The benevision n1 patient monitor (n1) was extensively tested, and no malfunction was detected.A detailed review of the device logs corresponding to the occurrence timeframe revealed that, for each non-invasive blood pressure (nibp) measurement initiated, the monitor consistently generated a "nibp cuff and patient mismatch" alarm.This alarm was active from 08:06:03 to 11:00:03, coinciding with the period of prolonged cuff inflation.Mindray concluded that the extended inflation was likely attributable to either an incompatibility between the patient type and the cuff, or a physical obstruction (e.G., blockage or kink) in the cuff's air tubing, which impeded normal deflation.The benevision n1 patient monitor performed per specifications and no malfunction was detected.

• Brand Name: BENEVISION N1
• 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
• MDR Report Key: 23156368
• Report Number: 2221819-2025-00019
• Device Sequence Number: 12097781
• Product Code: MHX
• UDI-Device Identifier: 06944904094922
• UDI-Public: 06944904094922
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025
• Report Date (Section F): 11/25/2025

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: BENEVISION N1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/03/2025
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 11/25/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/25/2025