BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADPRO MOBILE 40KW DIGITAL MOBILE X-RAY SYSTEM

    MDR report key: 7267939 · Received February 13, 2018

    Report

    Report Number
    1064504-2018-00001
    Event Type
    Malfunction
    Date Received
    February 13, 2018
    Date of Event
    February 8, 2018
    Report Date
    February 14, 2018
    Manufacturer
    SOCIEDAD ESPAÑOLA DE ELECTROMEDICINA Y CALIDAD S.A
    Product Code
    MQB
    UDI-DI
    08436046001510
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WV, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO VIRTUAL IMAGING, INC. BY (B)(6) OF (B)(6) ON (B)(6) 2018: ON (B)(6) 2018, (B)(6) (RADIOGRAPHIC TECHNOLOGIST) WAS DRIVING A RADPRO MOBILE 40 KW DIGITAL X-RAY SYSTEM (THE "UNIT") DOWN A HALLWAY BY THE CAFETERIA IN (B)(6) . (B)(6) DROVE THE UNIT OVER A METAL THRESHOLD, AND THE UNIT BEGAN PULLING TO THE LEFT AND DRIVING IN A CIRCLE. THE UNIT DROVE ONTO (B)(6)'S FOOT AND BENT HIS LEG INWARD, CAUSING KNEE PAIN. AT THIS TIME (B)(6) HIT THE EMERGENCY STOP BUTTON. UPON RESTARTING, THE UNIT WAS DRIVEN BACK TO THE MAIN DEPARTMENT OF (B)(6) WITHOUT ANY COMPLICATIONS. (B)(6) DID NOT SEEK MEDICAL HELP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111977 RADPRO MOBILE 40KW DIGITAL MOBILE X-RAY SYSTEM RADPRO MOBILE 40KW DIGITAL MOBILE X-RAY SYSTEM MQB SOCIEDAD ESPAÑOLA DE ELECTROMEDICINA Y CALIDAD S.A SM-40HF-B-D-C 08436046001510

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR