Description of Event or Problem · 1
THIS REPORTS PERTAINS TO A PT MONITOR MADE BY PHILLIPS. THE DEVICE PHILLIPS IS CALLED AN X2 MONITOR AND CONNECTS TO A LARGER MONITOR KNOWN AS THE MX800. THE CHALLENGE WITH THESE PRODUCTS ARE MULTIPLE AND LEAD TO POTENTIAL ADVERSE EVENTS. THE MAIN PROBLEM I HAVE ENCOUNTERED IS POOR USER INTERFACE WITH SYNCHRONIZING THE PORTABLE X2 MONITOR TO THE MX800. THE X2 MUST BE PAIRED TO THE MX800, AND IF THE CORRECT SEQUENCE OF PAIRING AND UNPAIRING IS NOT FOLLOWED, THAN THE MONITOR CANNOT BE PAIRED. THIS LEADS TO A SERIES OF ALARMS THAT GO OFF, WHICH CREATES A HAZARDOUS SIGNAL TO NOISE PROBLEM IN ENVIRONMENTS SUCH AS THE OPERATING ROOM AND INTENSIVE CARE UNIT WHERE CONSTANT ALARMS THAT CANNOT BE FIXED - I.E. AN UNPAIRED MONITOR ALARM- LEADS TO ALARM FATIGUE AND POTENTIALLY PREVENTS CLINICIANS FROM RECOGNIZING WHEN SIGNIFICANT ALARMS ARE OCCURRING INDICATING AN IMPORTANT PROBLEM AS OPPOSED TO THE UNPAIRED MONITOR ALARM BECAUSE THEY HAVE BECOME DESENSITIZED TO THE ALARMS THAT ARE OCCURRING. ANOTHER MAJOR PROBLEM OCCURS WHEN TRANSFERRING PTS AS THE MONITORS MUST BE TRANSFERRED IN AN EXACT SEQUENCE OF EVENTS FROM GOING FROM ONE CLINICAL AREA TO ANOTHER -I.E. OPERATING ROOM TO INTENSIVE CARE UNITS. IT IS NOT UNCOMMON FOR ME TO SEE SEVERAL BEDSIDE NURSES AND A DOCTOR TRYING TO FIGURE OUT HOW TO PAIR A MONITOR WHEN TRANSFERRING A CRITICALLY ILL PATIENT INSTEAD OF ACTUALLY FOCUSING ON THE CARE OF THE PT. ON ONE OCCASION WHEN A MONITOR IN THE OPERATING ROOM CONSISTENTLY PRODUCED A PAIRING ALARM, I CALLED OUR ENGINEERS TO INVESTIGATE. THE FIX REQUIRED AN ENGINEER TO RESET A MONITOR IN A LOCKED COMPUTER PANEL SEVERAL FLOORS AWAY. THERE IS NO WAY THE END USER COULD HAVE FIXED THE PROBLEM. THIS IS A DESIGN FAILURE. I HAVE COMMUNICATED THESE CHALLENGES TO THE MANUFACTURER AND THEY SEEM TO FEEL THAT THIS IS SIMPLY A USER PROBLEM AND THAT ONCE PEOPLE KNOW HOW TO USE THE PRODUCT THEY WILL BE ABLE TO MANAGE. I WOULD SUBMIT THAT SUCH THING DEMONSTRATES THE KIND OF SOFTWARE ENGINEERING PROCESSES THAT LED TO SUCH CATASTROPHIC FAILURES AS THE THERAC-25. I HOPE THAT NO PT DEATHS WILL OCCUR DUE TO THIS BAD DESIGN, BUT TO ASSUME THAT VERY SMART CLINICIANS SUCH AS ICU NURSES AND ANESTHESIOLOGISTS MUST FIDGET USED TO A MONITOR IS SIMPLY REDIRECTION ON A POORLY DESIGNED USER INTERFACE. A GOOD PRODUCT FOR SOMETHING AS IMPORTANT AS PT MONITORING SHOULD BE INTUITIVE WITH HARDLY ANY INSTRUCTION REQUIRED. PHILIPS DOES NOT SEEM ABLE TO RECOGNIZE THESE DESIGN FLAWS. PERHAPS WITH SOME INVESTIGATION FROM A REGULATORY BODY THEY WILL REALIZE WHERE IMPROVEMENTS CAN BE MADE.