MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD BENEVISION CENTRAL MONITORING SYSTEM

Model Number TM80 MAIN UNIT

Device Problem Device Alarm System (1012)

Patient Problem Insufficient Information (4580)

Event Date 11/27/2023

Event Type  Death  

Event Description

It was reported that during the case, on (b)(6) 2023, in the medsurg department, a patient was placed on the tm80 telemetry monitor id tele05 (serial number (b)(6) ) with batteries at bed 201.The nurse did not connect the tm80 with the workstation in the cmu.The patient was on the tm80 and in bed 201 between 13:00 and 23:25.During this time, the patient was connected to the tm80 and periodically checked by clinical staff.Later, it was verified that the patient had not been monitored or observed at the cmu workstation.At 18:07, the patient had a lethal arrhythmia event that was not detected by the personnel.Later, the patient was moved to ccu and connected to a hardwired patient monitor.The patient expired in ccu on (b)(6) 2023.

Manufacturer Narrative

Mindray field service representative verified the proper operation of the benevision dms and the tm80.System logs and patient database were collected for investigation.Mindray performed a review of the system logs and patient database, noting that when the patient meets the criteria for alarmed ecg events, both the tm80 telemetry monitor and benevision cms recorded the lethal alarm.The alarms were not being displayed at the cmu workstation because the user did not manually admit the online local workstation for the tm80 (bed 201) as per the facility configurations.The benevision dms in use with telemetry tm80 performed per specifications.

• Brand Name: BENEVISION CENTRAL MONITORING SYSTEM
• Type of Device: BENEVISION
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; 1203 nanhuan avenue; guangming district; shenzhen, guangming 51810 6; CH 518106
• MDR Report Key: 18452030
• MDR Text Key: 332182571
• Report Number: 2221819-2024-00001
• Device Sequence Number: 1
• Product Code: MSX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/04/2024,12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TM80 MAIN UNIT
• Device Catalogue Number: 120-021995-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death