Description of Event or Problem · 1
IN THE MORNING, THE BIOMED RESPONDED TO A PROBLEM IN THE OR. AESTIVA VENTILATOR STOPPED. DR. WAS MANUALLY BAGGING PATIENT. AESTIVA VENTILATOR HAD A WARNING MESSAGE, PROMPTING USER TO PUSH KNOB TO ACKNOWLEDGE VENT HAD EXPERIENCED A PROBLEM. DOING THIS CLEARED THE MESSAGE AND ALLOWED THE USER TO RETURN TO VENTILATOR MODE, HOWEVER, THE PROBLEM REAPPEARED AFTER A FEW MINUTES.DURING THIS TIME, SEVERAL OTHER VENTILATORS, SOME IN OTHER BUILDINGS, REPORTED THE SAME PROBLEM. IT WAS QUICKLY LEARNED THAT PICIS SYSTEM (EMR ELECTRONIC MEDICAL RECORD INTERFACES WITH AESTIVA AND OTHER PATIENT MONITORING EQUIPMENT) HAD A SOFTWARE UPDATE (PUSH) EARLIER IN THE MORNING. IT WAS DETERMINED AND VERIFIED THAT PICIS WAS THE SOURCE OF THE PROBLEM THAT AFFECTED ALL OF THE VENTS IN VENTILATOR MODE. PICIS WAS DISCONNECTED FROM THE AESTIVA AND PROBLEM WENT AWAY. SPOKE WITH GE TECH SUPPORT. WENT INTO THE SERVICE ERROR LOG ON THE AESTIVA. ALL VENTILATORS HAD A "WATCHDOG ERROR" IN THE LOG. INVESTIGATION REVEALED THAT THE PICIS UPDATE THAT WAS "PUSHED" CONTAINED A FILE THAT SHOULD NOT HAVE BEEN PUSHED OUT, CAUSING THIS PROBLEM. IT WAS NOT DETECTED BY PICIS OR HIS HEALTH INFORMATION SYSTEM PERSONNEL PRIOR TO THE PUSH. NO PATIENT HARM EXPERIENCED DUE TO THIS EVENT, HOWEVER THERE WAS A POTENTIAL FOR A MASS FAILURE OF ALL VENTILATORS CONNECTED TO THE PICIS SYSTEM.======================HEALTH PROFESSIONAL'S IMPRESSION======================THE PICIS SYSTEM SOFTWARE ADVERSELY AFFECTED ALL GE AESTIVA VENTILATORS THAT WERE PUT INTO THE VENTILATOR MODE. AESTIVAS NOT IN VENT MODE (BAG MODE) WERE NOT EFFECTED UNLESS THE MODE WAS SWITCHED TO VENT. THE PICIS SOFTWARE PATCH ADVERSELY AFFECTED 5 AESTIVAS.A FILE WAS PUSHED OUT THAT WAS KNOWN TO BE INCOMPATIBLE WITH AESTIVA, BUT WAS INADVERTENTLY LEFT IN THE PATCH. IT SHOULD HAVE BEEN REMOVED PRIOR TO THE PUSH. THE PUSH WENT OUT TO ALL CONNECTED PICIS HARDWARE, INCLUDING BOXES MOUNTED ON THE ANESTHESIA MACHINE THAT CONNECTS TO THE DATA PORTS OF THE AESTIVA.IT IS BELIEVED THAT THIS FILE UPLOADED TO THE PICIS BOX CAUSED A WATCHDOG ERROR (CPU TIMING CONFLICT) IN THE AESTIVA. THE TIMING INCOMPATIBILITY LOADED UP THE AESTIVA'S CPU BUFFER AND CREATING AN ERROR REALIZED BY THE WATCHDOG SEQUENCE WHICH LED TO THE EVENTS DESCRIBED ABOVE. THE USER CAN CLEAR THE ERROR AND RETURN TO VENTILATOR MODE.AFTER THE PICIS COMPONENTS WERE REMOVED, THE VENTILATOR WERE TESTED AND FOUND TO BE OPERATING CORRECTLY. HIS (IT DEPT) REMOVED THE BAD FILE FROM PATCH AND RETESTED TO ENSURE THERE WERE NO COMPATIBILITY ISSUES. THERE HAVE BEEN NO PROBLEMS SINCE.======================MANUFACTURER RESPONSE FOR ANESTHESIA VENTILATOR AND EMR INTERFACE DEVICE, (BRAND NOT PROVIDED)======================GE RESPONSE: INITIALLY, BASED ON THE ERROR CODE, GE SAID TO REPLACE THE CPU. BUT UPON FURTHER RESEARCH BY THEIR TECH SUPPORT DEPT, IT WAS DECIDED THAT THEY COULD PERFORM INTERNAL CPU DIAGNOSTIC TESTS TO ENSURE THE CPU WAS OPERATING NORMALLY.PICIS RESPONSE: THEY CONFIRMED THEY KNEW THIS FILE SHOULD NOT HAVE BEEN INCLUDED IN THE PATCH. ATTRIBUTED TO HUMAN ERROR.