Description of Event or Problem · 1
DURING ROUTINE INSPECTION OF THE STERIS 4085 TABLE A PROBLEM WAS IDENTIFIED WHICH INVOLVED UNORDERED AND ANOMALOUS MOVEMENT OF THE TABLETOP DURING CERTAIN ROUTINE ARTICULATIONS. THESE MOVEMENTS WILL CAUSE CONFUSION ON THE OPERATOR'S PART AND COULD POTENTIALLY LEAD TO SERIOUS PATIENT INJURY.THE NATURE OF THE PROBLEM IS AS FOLLOWS:STARTING OUT WITH THE TABLE LEVEL, WHEN "REFLEX" IS SELECTED THE TABLE BEGINS THE REFLEX MOVEMENT IN A SOMEWHAT NORMAL FASHION. THE BACK SECTION WILL RAISE SLIGHTLY, TOGGLE TO THE SEAT SECTION WHICH WILL RAISE SLIGHTLY, TOGGLE AGAIN TO THE BACK SECTION WHICH WILL RAISE SLIGHTLY, ETC. ETC. ETC., UNTIL THE DESIRED AMOUNT OF REFLEX HAS BEEN ACHIEVED. THE PROBLEM ARISES WHEN A PAUSE PRIOR TO ARRIVING AT THE DESIRED REFLEX POSITION TAKES PLACE. WHEN THE REFLEX BUTTON IS RELEASED, AND THEN RE-PRESSED FOR ADDITIONAL REFLEX ANGLE THE PROBLEM SHOWS UP. WHEN THE REFLEX BUTTON IS RE-PRESSED THE BACK SECTION WILL ACTUALLY MOVE IN THE OPPOSITE DIRECTION AND DROP BY SEVERAL DEGREES, HALT, CHANGE DIRECTIONS AGAIN, AND BEGIN AN UPWARD MOTION, THUS PICKING BACK UP FROM WHERE IT LEFT OFF. THE AMOUNT THE BACK SECTION WILL DROP DEPENDS ON WHERE AT IN THE CYCLE IT HAPPENED TO BE WHILE THE BACK WAS RAISING WHEN THE REFLEX BUTTON WAS RELEASED. IF THE REFLEX BUTTON IS RELEASED JUST PRIOR TO THE TABLE SHIFTING TO RAISING THE SEAT SECTION, THEN THE AMOUNT THAT THE BACK SECTION DROPS WILL BE MORE SUBSTANTIAL THAN IF THE BACK SECTION HAD JUST BEEN TOGGLED TO.DURING TROUBLESHOOTING IT WAS ALSO DISCOVERED THAT IF THE TABLE IS LESS THAN LEVEL, AS IN A FLEXED POSITION THEN NONE OF THESE PROBLEMS OCCUR AT ALL. THE BUTTON SELECTOR FOR REFLEX CAN BE REPEATEDLY PRESSED AND RELEASED WITH NO REVERSAL OF INTENDED DIRECTION ENCOUNTERED WHATSOEVER. IT IS ONLY WHEN THE TABLE IS AT LEVEL OR ABOVE AND THE REFLEX BUTTON IS SELECTED THAT THIS PROBLEM APPEARS.ADDITIONALLY, IF THE BACK IS RAISED, AND THIS COULD BE SUBSTANTIALLY SO, SAY 45' AS AN EXAMPLE, AND THE REFLEX KEY IS SELECTED, THE BACK SECTION WILL AGAIN GO IN THE OPPOSITE DIRECTION AND DROP ALL THE WAY DOWN TO BEING COMPLETELY LEVEL BEFORE THE SEESAW LIKE REFLEX ACTION WILL EVEN BEGIN TO TAKE PLACE.MANUFACTURER RESPONSE FOR SURGERY TABLE, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================THE IDENTIFIED PROBLEM WAS CALLED IN TO STERIS TECHNICAL SUPPORT, WHO INDICATED THAT A NEW CONTROL BOARD WAS NECESSARY TO REPAIR THE PROBLEM. A NEW CONTROL BOARD WAS PURCHASED AND INSTALLED WHICH DID NOT TAKE CARE OF THE PROBLEM. SUBSEQUENT PHONE CALLS TO STERIS TECHNICAL SUPPORT RESULTED IN HAVING A TECH SUPPORT REPRESENTATIVE PERSONALLY CHECK FOR AND VERIFY THE REPORTED PROBLEM ON THEIR TEST TABLE. THIS CONFIRMED FOR HIM THAT WHAT WAS BEING DESCRIBED WAS ACCURATE SO THE PROBLEM WAS THEN ESCALATED TO THE STERIS SURGICAL SUPPORT ENGINEERING GROUP. LATER, WHEN CHECKING BACK WITH STERIS TECHNICAL SUPPORT ON THE PROBLEM, IT WAS INDICATED THAT WHAT WE WERE EXPERIENCING WITH THE TABLE WAS COMPLETELY NORMAL AND NOT A PROBLEM. OF COURSE THIS WAS UNACCEPTABLE SO REMEDIATION WAS ALSO SOUGHT BY COMMUNICATING THIS ISSUE VIA THE SALES/ACCOUNT MANAGEMENT CHANNEL. AN ONSITE VISIT TOOK PLACE WHERE THE PROBLEM WAS DEMONSTRATED WHILE THE SALES REPRESENTATIVE SHOT LIVE DEMONSTRATION VIDEOS TO SEND UP LINES. SO FAR THERE HAS BEEN NO COMMUNICATION BACK DOWN THE CHAIN FROM STERIS ENGINEERING REGARDING ANY CORRECTIVE ACTION ACCORDING TO OUR STERIS SALES REP. ESTIMATED ETA IS "SEVERAL MONTHS".