Description of Event or Problem · 1
THIS MEDICAL DEVICE REPORT IS BEING SUBMITTED DUE TO A RECENT FDA INSPECTION HELD AT AGFA'S (B)(4) 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 (B)(4), 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, A DEALER SERVICE ENGINEER PERFORMED THE MANDATORY UPGRADE ON THE DX-D100 AT THE END USER LOCATION. THE SITE'S DX-D100 UNIT EXHIBITED MOTION PROBLEMS AFTER THE NEW DMC BOARD (REV H) UPGRADE WAS PERFORMED. THE SITE TECHNICIAN REQUIRED SUBSTANTIAL EFFORT TO PULL BACKWARDS ON A DOWNHILL SLOPE TO KEEP THE UNIT AT A REASONABLE SPEED. THE DEALER CONTACTED AGFA AND IT WAS 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 RECOMMENDED DEALER SERVICE DEINSTALL THE NEW DMC BOARD (REV H.) AND REPLACE WITH THE ORIGINAL OLD STYLE DMC BOARD, REV J, INTO THE DX-D100 UNIT TO KEEP THE SYSTEM IN USE. THE DEALER SERVICE COMPLETED THE DEINSTALL. THE INITIAL LONG TERM CORRECTION, DMC BOARD UPGRADE, FOR FDA REFERENCE #(B)(4), 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 # (B)(4).