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, (B)(4). 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 (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, AGFA REPORTED THE FOLLOWING: ONCE AGFA SERVICE PERFORMED THE MANDATORY UPGRADE, THE SITE'S DX-D100 UNIT DROVE VERY SLOWLY. AGFA SERVICE, BY CUSTOMER REQUEST, WAS ASKED TO REPLACE THE HANDLE GAUGES. AFTER THE HANDLE GAUGES WERE REPLACED, WHEN THE UNIT WAS STOPPED ON A RAMP AND THE USER LET GO OF THE HANDLE, THE UNIT WENT OUT OF CONTROL. THE UNIT EXHIBITED A DIFFERENT UNCONTROLLED DRIVING BEHAVIOR ON THE RAMP. AFTER AGFA INVESTIGATION WITH THE SUPPLIER, (B)(4), IT WAS DETERMINED THE DMC BOARD (REV H.) USED TO UPGRADE THE UNIT AS PART OF THE MANDATORY UPGRADE, WAS ACTUALLY A DEFECTIVE PART FROM OUR SUPPLIER, (B)(4). AS AN IMMEDIATE SOLUTION, AGFA SERVICE DEINSTALLED THE NEW DMC BOARD (REV H.) AND REPLACED WITH THE OLD DMC BOARD REV J, INTO THE DX-D100 UNIT TO KEEP THE SYSTEM IN USE. THE INITIAL LONG TERM CORRECTION, DMC BOARD UPGRADE, FOR (B)(4), HAS BEEN PLACED ON HOLD (B)(4) 2014 BY AGFA. INVESTIGATION BY BOTH AGFA AND THE SUPPLIER, (B)(4), IS UNDERWAY TO PROVIDE A DIFFERENT CORRECTION FOR THE DMC BOARDS. AT THIS TIME, THE 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 (B)(4).