BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100

    MDR report key: 3774013 · Received April 25, 2014

    Report

    Report Number
    9616389-2014-00022
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 25, 2014
    Manufacturer
    AGFA HEALTHCARE N.V.
    Product Code
    IZL
    PMA / PMN Number
    K103597
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    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 # 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 (B)(4) 2014. IN THIS SPECIFIC EVENT, A DEALER FIELD SERVICE ENGINEER PERFORMED THE MANDATORY UPGRADE ON THE DX-D100 AT THE END-USER SITE. THE CUSTOMER COMPLAINED AFTER THE UPGRADE THE UNIT DID NOT DRIVE AS FAST AS IT DID PRIOR TO THE UPGRADE AND ACCELERATES MORE SLUGGISHLY. THE DEALER ALSO EXPRESSED THE CUSTOMER'S CONCERN THAT WHEN GOING DOWN A HILL, THEY WERE HAVING A DIFFICULT TIME CONTROLLING THE UNIT, ESPECIALLY WITH SMALLER TECHNICIANS. AGFA'S INVESTIGATION WITH THE DEALER, 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. ATTACHED IS AN URGENT SAFETY NOTICE LETTER THAT WAS SENT TO THE DEALER ON (B)(4) 2014, DESCRIBING THE PROBLEM WHEN DRIVING THE UPGRADED UNITS ON RAMPS AND THE DEALER WILL SHARE THE LETTER WITH THE END USER. A WARNING LABEL, " DO NOT DRIVE ON RAMPS", WILL BE SENT TO THE DEALER TO ADHERE TO THE UPGRADED DX-D100 UNIT. THE INITIAL LONG TERM CORRECTION, DMC BOARD UPGRADE, FOR FDA REFERENCE # Z-1487-13, HAS BEEN PLACED ON HOLD (B)(6) 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 NEW DMC BOARD INSTALLED AND THE DEALER STATED THE CUSTOMER IS COMFORTABLE WAITING FOR THE FINAL CORRECTION. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252216 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