BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADPRO 40KW-DIGITAL MOBILE X-RAY SYSTEM

    MDR report key: 4188246 · Received September 29, 2014

    Report

    Report Number
    1064504-2014-00002
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 29, 2014
    Manufacturer
    SOCIEDAD ESPANOLA DE ELECTROMEDICINA Y CALIDAD S.A.
    Product Code
    IZL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO VIRTUAL IMAGING, INC. BY (B)(6) 2014. MS. (B)(6) REPORTED THAT A RADPRO 40KW-DIGITAL MOBILE X-RAY SYSTEM ("SYSTEM") DROVE IN THE REVERSE DIRECTION, CAUSING THE TECHNICIAN TO BECOME TRAPPED INA CORNER. SHE FURTHER REPORTED THAT THE DRIVE HANDLE WAS RELEASED, BUT THAT THE SYSTEM CONTINUED TO DRIVE IN REVERSE DIRECTION AND HIT THE WALL. MS. (B)(6) REPORTED THAT THE TECHNICIAN'S FINGER WAS FRACTURED DURING THE EVENT AND A HOLE WAS CREATED IN THE WALL BY THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604332 RADPRO 40KW-DIGITAL MOBILE X-RAY SYSTEM EASY MOVING PLUS IZL SOCIEDAD ESPANOLA DE ELECTROMEDICINA Y CALIDAD S.A. SM-40HF-B-D-C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention