Description of Event or Problem · 1
THIS MEDIAL DEVICE REPORT IS BEING SUBMITTED DUE TO A RECENT FDA INSPECTION HELD AT AGFA'S GREENVILLE, SC LOCATION, RISK REVIEW AND EVALUATION BY AGFA AND FURTHER INVESTIGATION BETWEEN AGFA AND OUR SUPPLIER, SEDECAL. AN ISSUE WAS IDENTIFIED THAT WHEN SOME DX-D100 MOBILE UNITS WERE INSTALLED A NEW DIGITAL MOTION CONTROL (DMC) BOARD, SOME CUSTOMERS ENCOUNTERED CHANGED DRIVING BEHAVIOR, ESPECIALLY DRIVING UP AND DOWN ON RAMPS. THE NEW DMC BOARD WAS PART OF A MANDATORY UPGRADE CORRECTION DESCRIBED IN FDA REFERENCE # Z-1487-13, TO CORRECT UNINTENDED MOVEMENT SOME DX-D100 UNITS WERE EXHIBITING. THE EVENT IN THIS REPORT OCCURRED ON (B )(6) 2014 AND IS BEING REPORTED ON APRIL 25, 2014. IN THIS SPECIFIC EVENT, AN AGFA FIELD SERVICE ENGINEER PERFORMED THE MANDATORY UPGRADE ON THE DX-D100 AT THE SITE. THE CUSTOMER COMPLAINED THE NEW DMC BOARD, REV H., ACTUALLY EXHIBITED MORE PROBLEMS REGARDING UNINTENDED MOVEMENT THAN THE ORIGINAL DMC BOARD. THE CUSTOMER STATED WHEN ATTEMPTING TO STOP THE UNIT SUDDENLY IT TOOK MORE EFFORT, TIME AND DISTANCE. THE CUSTOMER ALSO STATED WHEN THE UNIT WAS TAKEN UP EITHER ONE OF THE TWO RAMPS AT THE SITE, IN WHICH THEY HAD TO USE ON A DAILY BASIS, THE UNIT'S MOTOR NO LONGER PROVIDED ENOUGH ASSISTANCE TO DRIVE THE UNIT TO THE TOP OF THE RAMP WITHOUT CONSIDERABLE EFFORT FROM THE TECHNICIANS. SOME SMALLER FEMALE TECHNICIANS WERE INCAPABLE OF GETTING THE UNIT TO THE TOP OF THE RAMP. ADDITIONALLY, WHEN THE UNIT WAS STOPPED FACING UP A SLOPE, AS SOON AS THE DEAD MAN SWITCH WAS PRESSED TO ATTEMPT TO RESUME MOVEMENT, THE UNIT MOVED RAPIDLY BACKWARDS DOWN THE SLOPE AND WITH FORCE. GOING DOWN THE RAMP, THE UPGRADED UNIT MOVED RAPIDLY AND REQUIRED CONSIDERABLE PHYSICAL EFFORT TO RESTRAIN. USING THE SAME RAMP FOR COMPARISON, AN UNMODIFIED DX-D100 UNIT AT THE SITE WAS DRIVEN UP THE RAMP AND REQUIRED ALMOST NO EFFORT TO DRIVE DOWN THE RAMP. AGFA'S INVESTIGATION DETERMINED THE NEW DMC BOARD (REV H.) USED TO UPGRADE THE UNIT AS PART OF THE MANDATORY UPGRADE, WAS ACTUALLY A DEFECTIVE PART FROM OUR SUPPLIER, SEDECAL. AS AN IMMEDIATE SOLUTION, AGFA DEINSTALLED THE NEW DMC BOARD (REV H.) AND REPLACED WITH THE ORIGINAL OLD STYLE DMC BOARD INTO THE DX-D100 UNIT TO KEEP THE SYSTEM IN USE. THE INITIAL LONG TERM CORRECTION, DMC BOARD UPGRADE, FOR FDA REFERENCE # Z-1487-13, HAS BEEN PLACED ON HOLD (B)(4) 2014 BY AGFA. INVESTIGATION BY BOTH AGFA AND THE SUPPLIER, SEDECAL, IS UNDERWAY TO PROVIDE A DIFFERENT CORRECTION FOR THE DMC BOARDS. AT THIS TIME, THE END USE CUSTOMER'S UNIT STILL HAS THE OLD DMC BOARD INSTALLED. NO HARM WAS REPORTED FOR THIS EVENT. ANY FURTHER CORRECTION TO THIS SITE WILL BE REPORTED TO THE FDA VIA FDA REFERENCE # Z-1487-13.