TM80

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WITH A PACEMAKER CONNECTED TO A TM80 SERIAL NUMBER: (B)(6) WAS NOT GETTING ARRHYTHMIA ALARMS. THE CUSTOMER STATED THE PATIENT LOST PULSE WHILE STAFF WAS IN ROOM, CODE WAS CALLED AT 12:18 PM ON (B)(6) 2026. CLINICAL TEAM STATED THEY CODED PATIENT FROM 12:18-12:29 WHEN PATIENT WAS PRONOUNCED DECEASED. WHEN REVIEWING TELEMETRY STRIPS AFTER, CUSTOMER STATES THERE ARE MANY TIMES IN WHICH THEY BELIEVE ALARMS SHOULD HAVE BEEN CALLED BUT WERE NOT. SPECIFICALLY STATED TIMES OF: 12:13, 12:17:23 - 12:17:32 THERE SHOULD HAVE BEEN VENTRICULAR TACHYCARDIA (V-TACH) OR VENTRICULAR FIBRILLATION (V-FIB) ALARMS CALLED. THE PATIENT EXPIRED.

Additional Manufacturer Narrative

MINDRAY CONDUCTED AN INVESTIGATION THAT INCLUDED THE TEST OF THE UNITS INVOLVED AND THE REVIEW OF EVENT HISTORY LOGS FROM THE TM80 TELEMETRY UNIT AND THE ASSOCIATED BENEVISION DISTRIBUTED MONITORING SYSTEM (DMS) WORKSTATION, AS WELL AS AVAILABLE ECG WAVEFORM DATA AND PATIENT DATABASE INFORMATION. THE TM80 WAS TESTED USING A PATIENT SIMULATOR AND THE APPROPRIATE ALARMS WERE GENERATED. AUDIO WAS ALSO GENERATED AT THE BENEVISION WORKSTATION. THE LOG REVIEW DEMONSTRATED THAT, DURING THE REPORTED COMPLAINT PERIOD, THE ALGORITHMIC CRITERIA REQUIRED TO TRIGGER VENTRICULAR TACHYCARDIA (V-TACH) AND VENTRICULAR FIBRILLATION (V-FIB) ALARMS WERE NOT MET. AS SUCH, NO V-TACH OR V-FIB ALARMS WERE GENERATED BY THE SYSTEM DURING THE IDENTIFIED TIME PERIODS. THE ALARM BEHAVIOR OBSERVED WAS CONSISTENT WITH THE DEVICE'S SPECIFIED PERFORMANCE AND ALARM DETECTION THRESHOLDS. THE TM80 TELEMETRY UNIT IN USE WITH BENEVISION DMS PERFORMED PER SPECIFICATIONS.