BENEVISION DISTRIBUTED MONITORING SYSTEM (DMS)

Additional Manufacturer Narrative

MINDRAY CONDUCTED AN INVESTIGATION THAT INCLUDED FUNCTIONAL TESTING OF THE TM80 TELEMETRY UNIT USING A PATIENT SIMULATOR AND A REVIEW OF EVENT HISTORY LOGS FROM THE TM80 TELEMETRY UNIT AND THE ASSOCIATED BENEVISION DISTRIBUTED MONITORING SYSTEM (DMS) WORKSTATION, AS WELL AS AVAILABLE PATIENT DATABASE INFORMATION. FUNCTIONAL TESTING CONFIRMED THAT THE TM80 GENERATED THE APPROPRIATE ALARMS WHEN SIMULATED CONDITIONS WERE APPLIED. A REVIEW OF THE CENTRAL STATION, WORKSTATION, AND TM80 TELEMETRY LOGS DEMONSTRATED THAT AN ECG LEAD DISCONNECTION ALARM OCCURRED DURING THE REPORTED COMPLAINT PERIOD. NO CARDIAC RHYTHM ALARMS WERE GENERATED DURING THIS TIME, CONSISTENT WITH THE PATIENT NOT BEING CONNECTED TO ECG LEADS. THE LOG REVIEW IDENTIFIED NO ALARM RESET OR ALARM ACKNOWLEDGMENT OPERATIONS DURING THE REPORTED TIME FRAME. THE SEQUENCE OF EVENTS DOCUMENTED IN THE LOGS WAS CONSISTENT WITH THE CUSTOMER'S REPORT. THE TM80 TELEMETRY UNIT IN USE WITH BENEVISION DMS PERFORMED PER SPECIFICATIONS.

Description of Event or Problem

NO DEVICE MALFUNCTION WAS REPORTED BY THE CUSTOMER. IT WAS REPORTED THAT BETWEEN (B)(6) 2026, AT APPROXIMATELY 23:30 AND (B)(6) 2026, AT APPROXIMATELY 01:00, A PATIENT CONNECTED TO A TM80 UNIT AND SUBSEQUENTLY CONNECTED TO A BENEVISION DISTRIBUTED MONITORING SYSTEM (DMS) WORKSTATION EXPIRED WHILE NOT CONNECTED TO ECG LEADS. DURING THIS TIME PERIOD, THE PATIENT HAD REMOVED THE ECG LEADS. AS A RESULT, A "PATIENT DISCONNECTED FROM ECG" ALARM WAS PRESENT, AND NO CARDIAC RHYTHM ALARMS WERE GENERATED. CLINICAL STAFF WERE UNABLE TO ACKNOWLEDGE/SILENCE ALARMS FROM WORKSTATION DUE TO PRIOR EVENT.