BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DX-D600 -DXD IMAGING PACKAGE

    MDR report key: 4620865 · Received March 20, 2015

    Report

    Report Number
    9616389-2015-00006
    Event Type
    Malfunction
    Date Received
    March 20, 2015
    Date of Event
    May 23, 2013
    Report Date
    April 1, 2015
    Manufacturer
    AGFA HEALTHCARE N.V.
    Product Code
    KPR
    PMA / PMN Number
    K112670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    THE COVER LETTER ATTACHED IN THE INITIAL REPORT WAS DATED MARCH 20, 2014 AND SHOULD READ DATE OF MARCH 20, 2015. OMITTED SELECTION. SELECTION SHOULD BE "PRODUCT PROBLEM". STATEMENT IN 2ND SENTENCE READS " VIGILANCE ACTIVITY TO REPORT IDENTIFIED EVENTS WAS IMPLEMENTED (B)(6) 2014." THE YEAR SHOULD READ 2015. REPORT SOURCE SHOULD BE CHECKED AS : COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    STATEMENT IN 2ND SENTENCE READS " VIGILANCE ACTIVITY TO REPORT IDENTIFIED EVENTS WAS IMPLEMENTED (B)(6) 2014." THE YEAR SHOULD READ 2015.

    Description of Event or Problem · 1

    A RETROSPECTIVE REVIEW WAS PERFORMED BY AGFA FOR EVENTS, FROM YEARS 2012 TO MARCH 20, 2015, RELATED TO UNEXPECTED MOVEMENT OF DX-D600 SYSTEMS. VIGILANCE ACTIVITY TO REPORT IDENTIFIED EVENTS WAS IMPLEMENTED MARCH 19, 2014. THE FOLLOWING EVENT WAS IDENTIFIED AND IS BEING REPORTED TO THE FDA. A COMPLAINT WAS OPENED (B)(6) 2013 IN WHICH THE CUSTOMER REPORTED UNEXPECTED MOVEMENT OF THE DX-D600 Z-AXIS MOVEMENT. THE CUSTOMER REPORTED UNEXPECTED MOVEMENT OF THE DX-D600 OVERHEAD TUBE CRANE (OTC) TOWARDS THE REAR OF THE ROOM AND HITTING THE STOP WITH ENOUGH FORCE TO CAUSE CONCERN TO THE PATIENT. AFTER AN EXAMINATION ON THE WALLSTAND WITH THE BUCKY TILTED, THE USER USED THE AUTO POSITIONING TO PLACE THE TUBE FOR THE NEXT EXPOSURE. DURING THE FINAL VERTICAL MOVEMENT, THE TUBE FELL DOWN INTO POSITION, AS IF THE BRAKES DIDN'T WORK. THE PATIENT WAS LYING IN BED INSIDE THE ROOM (IT WAS HIS 2ND EXPOSURE) AND THE TUBE FELL DOWN NEAR HIS HEAD. THERE WERE NO REPORTS OF HARM TO ANY PATIENT OR USER. AGFA REPLACED TACHOMETER, MOTOR, GAUGE PCB AND VERTICAL PCB AND SYSTEM WAS OPERATIONAL AND SYSTEM MOVEMENT WAS AS EXPECTED. ROOT CAUSE WAS DETERMINED TO BE THE TACHOMETER SIGNAL WAS LOOSE THAT MADE THE SERVO ELECTRONICS TO PERFORM MOVEMENT TO ITS MAXIMUM SPEED CAPABILITY TO THE INTENDED FINAL DESTINATION. ON JUNE 30, 2014, VIGILANCE ACTIVITY WAS INITIATED TO REPORT CORRECTIONS TO HEALTH CANADA (HC# 10168) FOR A MANDATORY SOFTWARE UPGRADE OF DX-D600 FULL AUTOMATIC SYSTEMS TO VERSION 3.6 TO PREVENT UNEXPECTED SYSTEM MOVEMENTS. ON DECEMBER 12, 2014, VIGILANCE ACTIVITY WAS ALSO INITIATED TO REPORT ADDITIONAL CORRECTIONS TO HEALTH CANADA (HC# 10168) TO IMPLEMENT THE MANDATORY UPGRADE OF SEMI-AUTOMATIC DX-D600 SYSTEMS TO VERSION 3.6 TO PREVENT UNEXPECTED SYSTEM MOVEMENTS AND TO IMPLEMENT THE MANDATORY UPGRADE OF ANALOG MANUAL DX-D600 SYSTEMS TO AN IMPROVED DETENT FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189890 DX-D600 -DXD IMAGING PACKAGE DX-D 600 SYSTEM KPR AGFA HEALTHCARE N.V. DX-D600

    Patients

    Seq Age Sex Outcome Treatment
    1