Description of Event or Problem · 1
INCIDENT OCCURRED ON 11/16/96 ABOUT 17:40 IN ROOM. AN ADULT MALE ARRIVED IN ER ABOUT 16:30 AND WAS IDENTIFIED AS BEING IN TERMINAL STAGES OF CANCER. HE WAS CONNECTED TO MONITOR BY A NURSE AND MONITOR HAD BEEN TURNED "ON." NURSE HAD CHECKED PT ABOUT 17:30. ABOUT 10 MIN LATER NURSE ENTERED ROOM AND PT HAD DIED. NO ALARMS HAD SOUNDED AT EITHER BEDSIDE OR AT CENTRAL NURSES STATION. VISUAL INSPECTION OF POWER CORD, DATA CABLE, AND MONITOR WAS PERFORMED PRIOR TO ELECTRICAL INSPECTION AND POWER CORD WAS WITHOUT CUTS IN CORD AND PINS, PLUG, AND STRAIN RELIEF WERE IN GOOD REPAIR. DATA CABLE WAS DUSTY BUT OTHERWISE WITHOUT CUTS OR OBVIOUS SIGNS OF DETERIORATION. DEVICE WAS INTACT WITH DATA CABLE AND PT CABLE PLUGGED INTO THE MONITOR; CASE WAS WITHOUT ABNORMAL CRACKS, CUTS, DENTS AND LIKE AND EXHIBITED NORMAL PAINT NICKS FOR A DEVICE OF ABOUT 8 YEARS USE. WHITE TAPE WAS PLACED ON FRONT SURFACE OF MONITOR WITH INKED MESSAGE "INOP. DO NOT TOUCH; EVIDENCE FOR INVESTIGATION BY BIOMED; DO NOT REMOVE CABLE." LEAD SELECTOR SWITCH WAS IN LEAD II POSITION. NO TEMP PROBES WERE PROVIDED. THIS UNIT IS CAPABLE OF MONITORING ECG, HEART RATE, APNEA, RESPIRATION, AND TWO TEMPS. WHEN FIRST TURNING MONITOR POWER BUTTON "ON" FOUR SELF TESTS WERE PERFORMED AND INDICATED "PASS" ON FOUR TESTS. INDIVIDUAL LAMPS ON EACH OF APPROPRIATE BUTTONS LIT BRIEFLY AND THEN EXTINGUISHED. DEVICE WAS FIRST TESTED IN A VACANT ROOM IN ICU AND WITHOUT CONNECTION TO THE TOTAL SYSTEM. FOLLOWING VISUAL INSPECTION AN ECG SIMULATOR WAS SET UP WITH AN 80 BPM RATE AND CONNECTED TO MONITOR. THE MONITOR WAS POWERED "ON" AND IT WAS VERIFIED THAT WITHIN FIRST APPROX 10 SECS, SELF TEST WAS PERFORMED, AND PASSED, AND AN ECG APPEARED ON SCREEN, THE RATE WAS MEASURED AS 79 B/M AND "ALARMS OFF" STATUS WAS DISPLAYED ABOVE HEART RATE. SIMULATOR WAS THEN TURNED TO "OFF." BASELINE DROPPED TO A FLAT LINE, RATE WENT TO --- AND NO AUDIBLE ALARM SOUNDED. ON OUTSIDE OF WALL OF PT ROOM, WAS LOCATED A SECURITY ROOM THAT CONTAINED MANY MONTORS FOR THE CLOSED CIRCUIT VIEWING OF PTS IN THE ER. AN INTERVIEW WITH THE SECURITY PERSON ON DUTY INDICTED THAT THEY DO OCCASIONALLY USE A WALKIE-TALKIE IN THIS ROOM BUT NOT FREQUENTLY. IN GENERAL, ALL AREAS OF THE HOSP IN WHICH CELLULAR PHONES AND WALKIE-TALKIES CANNOT BE USED, ARE POSTED. IT IS THE OPINION OF THE HOSP, BIOMEDICAL ENGINEER THAT THE MONITOR MEETS THE MFRS SAFETY AND PERFORMANCE REQUIREMENTS. THERE IS NO INDICATION THAT ELECTROMAGNETIC INTERFERENCE WAS INVOLVED IN THIS EVENT. ONE MINOR CORRECTION SHOULD BE MADE IN THE ER MONITORING SYSTEM. THE CORRECT TIME SHOULD BE SET SUCH THAT THE DATE/TIME PRINT OUT OF THE CENTRAL STATION PRINTER IS CORRECT. THE COMMITTE MADE THE DECISION FOR THIS REPORTING ON 2/13/97.