BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DX-D600 - DXD IMAGING PACKAGE

    MDR report key: 8066807 · Received November 13, 2018

    Report

    Report Number
    9616389-2018-00017
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    October 19, 2018
    Report Date
    November 13, 2018
    Manufacturer
    AGFA N.V.
    Product Code
    KPR
    PMA / PMN Number
    K112670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO RECENT CHANGES, AGFA (B)(4) IS NOW SEPARATE FROM AGFA HEALTHCARE (B)(4). AGFA (B)(4) IS CURRENTLY AWAITING THE ASSIGNMENT OF A FDA REGISTRATION NUMBER. THIS REPORT HAS BEEN SUBMITTED VIA THE MANUFACTURER REGISTRATION NUMBER 9616389 FOR AGFA HEALTCARE (B)(4). FOR THIS REPORT, THE MFR REPORT # 9616389-2018-00017 SHOULD BE 10058267-2018-00002, HOWEVER DUE TO TECHNICAL RESTRAINTS OF THE ESUBMITTER SYSTEM, THE AGFA (B)(4) OWNER/OPERATOR NUMBER COULD NOT BE ENTERED INTO THE MFR REPORT # FIELD.

    Description of Event or Problem · 1

    A CUSTOMER IN THE US REPORTED TO AGFA WHEN USING THEIR DX-D 600 SYSTEM, THE TUBE WAS MOVING AT AN ABNORMAL SPEED. THE CUSTOMER REPORTED THE TUBE WAS MOVING AROUND THE ROOM QUICKLY AND NOT LINING UP WITH THE BOARD. DURING THE INVESTIGATION BY AGFA, AGFA SERVICE CONFIRMED THE SYSTEM WAS MOVING AT AN ABNORMAL SPEED IN THE TRANSVERSAL DIRECTION. AGFA SERVICE REPLACED THE TACHOMETER, WHICH CONTROLS THE SPEED OF THE UNIT THE TRANSVERSAL DIRECTION. AGFA SERVICE TESTED THE UNIT AND AUTO CENTERED THE UNIT THREE TIMES TO THE WALL AND TABLE WITH NORMAL TRANSVERSAL SPEED MOVEMENT. THE UNIT IS NOW WORKING AS INTENDED. THERE HAS BEEN NO REPORTED HARM TO PATIENT OR USER DURING THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905237 DX-D600 - DXD IMAGING PACKAGE DX-D 600 SYSTEM KPR AGFA N.V.

    Patients

    Seq Age Sex Outcome Treatment
    1