BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100

    MDR report key: 3895948 · Received June 26, 2014

    Report

    Report Number
    9616389-2014-00024
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 26, 2014
    Manufacturer
    AGFA HEALTHCARE N.V.
    Product Code
    IZL
    PMA / PMN Number
    K103597
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS MEDIAL DEVICE REPORT IS BEING SUBMITTED DUE TO AN ADDITIONAL EVENT THAT WAS ORIGINALLY REPORTED IN MDR REPORT, FDA # 9616389-2013-00003, BUT AT A DIFFERENT SITE. THIS REPORT IS FOR A 19TH EVENT IN WHICH THE CUSTOMER INFORMED AGFA ON (B)(6) 2014, THAT THE SITE HAD EXPERIENCED THEIR DX-D100 UNIT EXHIBITING ERRATIC MOVEMENT WHEN DRIVING THE UNIT. THE DX-D100 UNIT WAS NEWLY INSTALLED AT THE CUSTOMER SITE AND THIS EVENT OCCURRED ON THE FIRST DAY OF USE WITH THE NEW UNIT. THE CUSTOMER EXPERIENCED INTERMITTENT MOVEMENT WITH THE UNIT MOVING IN THE OPPOSITE DIRECTION. WHEN THE TECHNICIAN WAS BACKING THE UNIT UP AND LET GO OF THE HANDLE THE UNIT WOULD SLIGHTLY MOVE FORWARD. WHEN THE TECHNICIAN WAS MOVING THE UNIT FORWARD AND LET GO OF THE HANDLE THE UNIT WOULD SLIGHTLY MOVE BACKWARDS. NO HARM HAS BEEN REPORTED FOR THIS EVENT AND THE CUSTOMER, AT THIS TIME, HAS ELECTED TO CONTINUE TO USE THE NEWLY INSTALLED UNIT. AGFA INVESTIGATION WAS ALREADY UNDERWAY FOR A REPORTABLE CORRECTION TO THE FDA ON MAY 15, 2013: FDA REFERENCE # Z-1487-13. FOR ANY POTENTIAL CORRECTIONS FOR THIS DX-D 100 UNIT, DOCUMENTATION WILL BE PROVIDED VIA FDA Z-1487-13.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374698 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