Description of Event or Problem · 1
EXCESSIVE ELECTRICAL LEAKAGE CURRENT WHEN CLINICOMP'S CLINICAL INFORMATION SYSTEM IS CONNECTED TO MED EQUIPMENT. DURING ROUTINE SAFETY INSPECTIONS IN NEONATAL INTENSIVE CARE AND LABOR AND DELIVERY SECTIONS, BIOMEDICAL EQUIPMENT TECHNICIAN MEASURED A GREATER THEN 1.999 MILLI-AMPS WITH A MAXIMUM LIMIT OF 300 MICRO-AMPS. THAT READING WAS EXCEPTION, MOST READINGS WERE ONLY DOUBLE ALLOWABLE. WHEN CLINICAL INFORMATION SYSTEM WAS DISCONNECTED AT SOURCE OR "COMM CLOSET" READINGS RETURNED TO 8 TO 12 MICRO AMPS. WITH INVESTIGATION,FOLLOWING TWO PROBLEMS WERE DETERMINED. SINCE THERE WERE TWO DIFFERENT SECTIONS INVOLVED AND EACH SECTION WAS SERVED BY DIFFERENT TYPES OR MODELS OF CLINICOMP EQUIPMENT EACH SECTION WAS TREATED SEPARATELY. NICU, HAD A CLINICOMP "POWER PATCH PANEL" WHICH BEDSIDE SMC BOXES FEED MED DATA. TROUBLESHOOTING DETERMINED THAT THERE WERE TWO PORTS WHICH WERE CAUSING EXCESSIVE LEAKAGE CURRENT. WHEN OTHER PORTS WERE USED LEAKAGE CURRENT DROPPED WITHIN TOLERANCE, AVERAGING 110 MICRO AMPS, (BEFORE CLINICOMP AVERAGE WAS 10 MICRO-AMPS.) CLINICOMP SENT A NEW "POWER PATCH PANEL," AFTER IT WAS INSTALLED IT WAS DETERMINED TO HAVE MORE PORTS MALFUNCTIONING THEN ORIGINAL PANEL. SO THE ORIGINAL PANEL WAS PUT BACK AND NEW" ONE WAS SENT BACK TO CO FOR EVAL. CURRENT STATUS: ALL MED EQUIPMENT IN NICU IS WITHIN ELECTRICAL SAFETY TOLERANCE, REF NFPA 99. LABOR AND DELIVERY, USED A MODEL "DAS 422" IN THE COMMUNICATION CLOSET RECEIVING MED DATA FROM BEDSIDE MONITORS THROUGH A 1MC MINI-DAS BOX IN PT RM. WITH TROUBLESHOOTING LOCAL BMET AND INFO SYS SPECIALIST DETERMINED THAT SIGNAL GROUND SHOULD BE SEPARATED FROM CHASSIS GROUND ON FRIDAY 6 MARCH. MONDAY, 9 MARCH, CO DETERMINED THAT DESIGN OF DAS 422 SHOULD BE MODIFIED TO SEPARATE LOGIC GROUND FROM CHASSIS GROUND INSIDE THEIR UNIT. CLINICOMP TECH "DISCONNECTED RESISTERS" INSIDE UNIT. TO DATE WHICH RESISTERS HAS NOT BEEN DESCRIBED OTHER THEN THAT IS REMOVED LOGIC GROUND FROM CHASSIS GROUND. AGAIN RESULTS ARE WITHIN TOLERANCE OF 300 MICRO-AMPS. CURRENT ELECTRICAL SAFETY CHECKS INVOLVING CURRENT LEAKAGE ON MED EQUIPMENT ARE RESULTING IN AN AVERAGE OVER 100 MICRO-AMPS, PREVIOUS READINGS WERE AVERAGING 10 MICRO-AMPS. BIO-MEDICAL DEPTS CHECK ELECTRICAL LEAKAGE CURRENT AFTER INSTALLATION OF ANY CENTRAL INFO GATHERING SYS BEING INSTALLED. MED EQUIPMENT BE INSPECTED IN AREA OF USE, AT BEDSIDE, AND IN CONFIGURATION OF "NORMAL STAFF USE." INDEPENDENT ENGINEER HAS EVALUATED TYPE I COMPLAINT SUBMITTED ON CLINICOMP CLINICAL INFO SYS AND SUPPORT THEIR CLASSIFICATION AS A TYPE I COMPLAINT. FIRST, WHATEVER REASON, A LEAKAGE CURRENT OF 1.999 MILLIAMPS (1999 MICROAMPS) IS WELL ABOVE ALLOWABLE LIMIT FROM (NFPA 99. 9-2.1.13.4 (C)) OF 300 MICROAMPS. THIS CHASSIS LEAKAGE CURRENT LIMIT IS NOT BASED ON TECHNICAL EVIDENCE, BUT ON CONSIDERED OPINION. IF A PARTICULAR PIECE OF MED EQUIPMENT HAS A CHASSIS LEAKAGE CURRENT ABOVE 300 MICROAMPS, IT DOES NOT MEAN THAT IT IS DANGEROUSLY UNSAFE.