BEUDAMED
    FDA Adverse Event Other Summary report: N

    SWISSRAY DDR MODULAIRE SYSTEM

    MDR report key: 1039439 · Received May 2, 2008

    Report

    Report Number
    3031197-2008-00001
    Event Type
    Other
    Date Received
    May 2, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 30, 2008
    Manufacturer
    SWISSRAY INTERNATIONAL, INC.
    Product Code
    KPR
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MANUFACTURER/IMPORTER WAS TELEPHONICALLY NOTIFIED BY THE EQUIPMENT OWNER / ENDUSER OF AN INCIDENT IN WHICH A PT WAS INJURED DURING MOVEMENT OF THE X-RAY SYSTEM. THE EQUIPMENT OWNER HAS PROVIDED FEW DETAILS AND HAS REFUSED ACCESS TO PERSONS INVOLVED IN THE INCIDENT INCLUDING THE INJURED PT AND THE TECHNICIAN (S) OPERATING THE EQUIPMENT AT THE TIME OF THE INCIDENT. THE PT INVOLVED IN THE INCIDENT HAS NOT BEEN IDENTIFIED TO THE MFR. THEREFORE, THIS DESCRIPTION OF THE EVENT RELIES SOLELY UPON THE INITIAL, SECOND-HAND INFO PROVIDED BY THE EQUIPMENT OWNER. THE INCIDENT WAS CALLED IN TO SWISSRAY'S SALES REP BY THE CHIEF EXECUTIVE OFFICER OF THE FACILITY. HE REPORTED THAT AN INCIDENT OCCURRED IN 2008, IN WHICH THE BUCKY (X-RAY DETECTOR ASSEMBLY) OF A SWISSRAY DDR MODULAIRE SYSTEM CAME DOWN ON A FEMALE PT'S FOOT, FRACTURING THE FOOT AND SEVERING A TOE. THE PROCEDURE BEING PERFORMED AT THE TIME WAS A SUNRISE KNEE IMAGE. THE PT REPORTEDLY UNDERWENT SURGERY TO REPAIR THE INJURY TO HER FOOT AND TOE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWISSRAY DDR MODULAIRE SYSTEM KPR - SYSTEM, X-RAY, STATIONARY KPR SWISSRAY INTERNATIONAL, INC. 6.1033.0004.4 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other