BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100

    MDR report key: 3773991 · Received April 25, 2014

    Report

    Report Number
    9616389-2014-00019
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    February 26, 2014
    Report Date
    April 25, 2014
    Manufacturer
    AGFA HEALTHCARE N.V.
    Product Code
    IZL
    PMA / PMN Number
    K103597
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS MEDIAL 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 REFERENCE # (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 (B)(6) 2014. IN THIS SPECIFIC EVENT, AGFA REPORTED THE FOLLOWING: ONCE AGFA SERVICE PERFORMED THE MANDATORY UPGRADE, THE SITE'S DX-D100 UNIT DROVE ACCEPTABLE ON THE LEVEL FLOOR. THE CUSTOMER SUGGESTED TESTING THE UNIT ON A SLOPE AND THE RESULT WAS IF THE UNIT WAS PUSHED, THE SPEED INCREASED WELL BEYOND THE MAXIMUM OF 5KM/HR. IF THE HANDLE WAS RELEASED, THE BRAKE BROUGHT THE UNIT TO A STOP WITHIN 4 - 5 FEET. THE CUSTOMER'S ISSUE WAS WHEN GOING DOWN THE SLOPE THEY NEEDED TO PULL BACK AGGRESSIVELY TO MAINTAIN REASONABLE SPEED AND DRIVING UP THE SLOPE REQUIRED MORE EFFORT THAN WHEN THE OLD DMC BOARD WAS INSTALLED IN THE UNIT. TO CONFIRM THE ISSUE WITH THE NEW DMC BOARD, AGFA SERVICE INSTALLED A DIFFERENT NEW DMC BOARD AND EXPERIENCED THE SAME RESULT. AFTER AGFA SERVICE INVESTIGATION, IT WAS DETERMINED THE NEW DMC BOARDS (REV H.) USED TO UPGRADE THE UNIT AS PART OF THE MANDATORY UPGRADE, WERE ACTUALLY DEFECTIVE PARTS FROM OUR SUPPLIER, SEDECAL. AS AN IMMEDIATE SOLUTION, AGFA SERVICE 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 SYSTEM IS WORKING ACCEPTABLE FOR THE CUSTOMER. 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 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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252587 DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 DX-D 100 MOBILE WIRELESS IZL AGFA HEALTHCARE N.V. DX-D100 MOBILE WIRELESS DR

    Patients

    Seq Age Sex Outcome Treatment
    1