BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADPRO MOBILE 3

    MDR report key: 3986855 · Received July 23, 2014

    Report

    Report Number
    1064504-2014-00001
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 23, 2014
    Manufacturer
    SEDECAL INC.
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO VIRTUAL IMAGING, INC. BY (B)(6). ON (B)(6) 2014 AT APPROX 10:08 AM, (B)(6) WAS DRIVING THE RADPRO MOBILE 3 OFF THE ELEVATOR WHEN THE MACHINE MADE A LOUD "SCREECHING" SOUND AND CAME TO AN ABRUPT STOP. THE RADPRO MOBILE 3 THEN STARTED BEEPING AND SUDDENLY WENT IN REVERSE AT FULL SPEED. (B)(6) WAS PINNED UP AGAINST THE ELEVATOR WALL. (B)(6) QUICKLY LIFTED THE COLLIMATOR TO ATTEMPT TO STOP THE MACHINE FROM DRIVING IN REVERSE, BUT THE MACHINE DID NOT RESPOND. (B)(6) WAS ABLE TO REMOVE HERSELF FROM BEHIND THE RADPRO MOBILE 3; HOWEVER, THE RADPRO MOBILE 3 CONTINUED TO DRIVE IN REVERSE, STRIKING THE ELEVATOR WALL ABOUT 15 TIMES BEFORE IT STOPPED ON ITS OWN. THERE WAS A VERY STRONG BURNING SMELL COMING FROM THE RADPRO MOBILE 3 THAT WAS NOTICED BY (B)(6) BEFORE THE RADPRO MOBILE 3 STOPPED. (B)(6) WAS EXAMINED BY MEDICAL PERSONNEL FOR A BRUISED HIP AND WAS GIVEN PERMISSION TO RETURN TO HER NORMAL DUTIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432353 RADPRO MOBILE 3 EASY MOVING PLUS IZL SEDECAL INC. SM-40HF-B-D-C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other