Description of Event or Problem · 1
CLINICAL STAFF PROVIDED A FULL DISCLOSURE PRINT OUT FOR (B)(6) 2018 21:43 - 21:48 TO THE BIOMED DEPT. THE BIOMED DEPT PULLED LOGS FROM THE CENTRAL STATION FOR TIME FRAME INCLUDED WITHIN THE FULL DISCLOSURE. CLINICAL STAFF'S REPORTED ISSUE OF THE MONITOR NOT ALARMING FOR THREE MINS WHILE THE PT WAS IN V. FIB WAS CONFIRMED. EVENT 1: (B)(6) 2018 9:44:01 PM - THE PT WAS ADMITTED ON THE MONITOR ENABLING THE MONITORING FUNCTION. THIS IS INDICATED BY THE EVENT CATEGORY OF LEADS OFF; 9:44:01 - CATEGORY LEADS OFF. EVENT 2: (B)(6) 2018 9:44:04 PM - THE MESSAGE LEARNING WAS DISPLAYED ON THE SCREEN. INDICATING THAT THE ECG LEADS HAD BEEN CONNECTED TO THE PT AND THE MONITOR WAS LEARNING THE PT'S UNIQUE RHYTHM. AT 9:44:04 - MESSAGE SHOWN "LEARNING". EVENT 3: (B)(6) 2018 9:44:40 PM - THE MESSAGE BIGEMINY WAS REPORTED TO HAVE BEEN DISPLAYED ON THE MONITOR. NO ASSOCIATED ALARM TONES OR COLORS WERE DISPLAYED. PRIORITY IS SET TO INFO. AT 9:44:40 - MESSAGE SHOWN "BIGEMINY". EVENT 4: (B)(6) 2018 9:44:46 PM - THE MESSAGE V. FIB WAS REPORTED TO HAVE BEEN DISPLAYED ON THE MONITOR. NO ASSOCIATED ALARM TONES OR COLORS WERE DISPLAYED. PRIORITY IS SET TO INFO. AT 9:44:46 - MESSAGE SHOWN "V. FIB" AT APPROX 9:45:04 THE ALARM FUNCTIONALITY SHOULD HAVE RETURNED TO THE MONITOR PER DEFAULT SETTINGS (SETTINGS WILL BE COVERED IN DETAIL BELOW). EVENT 5: (B)(6) 2018 9:47:13 PM (1), THE ALARM SUSPEND MODE WAS EXITED INDICATED BY THE CATEGORY ALARMS ON IN THE EVENT LOG. TYPE IS SET TO INFO. AT 9:47:13 - ALARMS ON. EVENT 6: (B)(6) 2018 9:47:13 PM (2) - THE CRISIS V. FIB ALARM WAS GENERATED. WITH A TYPE OF WARNING AND A CATEGORY OF V. FIB. AT 9:47:13 - CRISIS V. FIB AFTER AN ANALYSIS OF THE BSM6000 OPERATORS MANUAL PG 53 IT WAS FOUND THAT NORMAL OPERATION FOR THE 6000 SERIES OF MONITORS IS THE FOLLOWING: WHEN ADMITTING OR DISCHARGING A PT OR WHEN THE MONITOR POWER IS TURNED ON, ALARMS ARE AUTOMATICALLY SUSPENDED. ALARM FUNCTION RESUMES WHEN THE MONITORING CONDITIONS ARE CONTINUOUSLY MET OR THE SUSPEND ALARMS KEY IS TOUCHED. THE MONITORING CONDITIONS ASSOCIATED WITH THE ALARM ACTIVATION DELAY CAN BE FOUND ON PAGE 54 OF THE BSM6000 OPERATORS MANUAL. THE ALARM ACTIVATION DELAY DEFAULT SETTING FOR THE CCU MONITORS IS 1 MIN. ACCORDING TO THE BSM6000 OPERATORS MANUAL WITH A SETTING OF 1 MIN FOR THE ALARM ACTIVATION DELAY, THE MONITORING CONDITIONS THAT MUST BE CONTINUOUSLY MET ARE: ECG SPO2 OR IBP IS CONTINUOUSLY MONITORED FOR THE SELECTED TIME (IN THIS CASE 1 MIN); NIBP IS MEASURED (SYS, DIA OR MAP VALUES MEASURED); HEART RATE BECOMES 0. THE BIOMED DEPT WAS ABLE TO SIMULATE AND DUPLICATE THE REPORTED ISSUE ON ANOTHER CCU MONITORS. AFTER SIMULATING THE PT BEING CONNECTED TO THE MONITOR AND THEN PROMPTLY GOING INTO V. FIB THE MONITOR WOULD NOT EXIT THE ALARM SUSPENDED STATE AFTER THE 1 MIN INTERVAL. ONE TEST LASTED FOR MORE THAN 19 MINS BEFORE THE MONITOR ALARMED. THIS APPEARS TO BE DUE TO THE REQUIREMENT FOR CONTINUOUS FOR THE DELAY TIME SETTING. DURING THE V. FIB, THE MONITOR WOULD LOSE THE NUMERIC VALUE FOR THE HR. THIS CAUSES THE ALARM ACTIVATION DELAY TIME TO KEEP REFRESHING. FINDINGS INDICATE THAT: NO OMC STAFF MEMBER INTENTIONALLY ALTERED MONITORING FUNCTIONALITY; THE MONITOR PRESENT DURING THE INCIDENT WAS OPERATING WITHIN THE SETTINGS AND PARAMETERS PROGRAMMED; THE LOGIC BEHIND THE PROGRAMMED SETTINGS IS FLAWED AND DOES NOT EFFECTIVELY OR SAFELY HANDLE THE SITUATION OF A V. FIB DURING THE ALARM ACTIVATION DELAY TIME. RECOMMENDATIONS IN ORDER TO PREVENT THIS TYPE OF INCIDENT FROM OCCURRING AGAIN, THE BIOMED DEPT RECOMMENDS THAT THE ALARM ACTIVATION DELAY SETTING BE SET TO AUTO. ACCORDING TO THE BSM6000 OPERATORS MANUAL PG 54, THE AUTO SETTING WILL EXIT THE ALARMS SUSPENDED STATE IF THE FOLLOWING CONDITIONS ARE MET.