BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHIMADZU MOBILEDART EVOLUATION

    MDR report key: 3810941 · Received March 23, 2014

    Report

    Report Number
    8030233-2014-00001
    Event Type
    Malfunction
    Date Received
    March 23, 2014
    Date of Event
    February 17, 2014
    Report Date
    March 20, 2014
    Manufacturer
    SHIMADZU CORP.
    Product Code
    OWB
    PMA / PMN Number
    K092439
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO MANUFACTURE. IMAGE AND LOG FILE WERE SENT TO THE COMPONENT MANUFACTURE (CANON INC.). THE X-RAY MOBILE SYSTEM IS CONSIST OF FLAT PANEL DIGITAL RADIOGRAPHY UNIT CANON CXDI-70C. THAT WAS A SAME ERROR WHICH THE COMPONENT MANUFACTURE (CANON INC.) HAVE EXPERIENCED AND ANALYZED IN THE PAST. THIS ERROR CAUSED BY THE TIMING AT WHICH CONNECTING OR DISCONNECTING WITH MEMORY IS PROCESSED WHEN EXPOSURES ARE TAKEN AND THE TIMING AT WHICH THE PREVIEW IMAGE ARE STORED. IT WAS RESULTED IN FAILURE TO STORE RAW IMAGES. THE FES WAS ADVISED TO TURN THE SHARPNESS SETTING OF AND TO UPGRADE THE SOFTWARE TO NE V1.40.3 OR V2.02. THE NE SOFTWARE WILL BE UPGRADED TO NE V1.40.3 OR 2.02. SOON. THOSE VERSIONS RESOLVE THE ISSUE OF THE INTERMITTENT BLANK IMAGES WITH SHARPNESS ON IN THE PROTOCOL. WE FOLLOW THE ABOVE RECOMMENDATION BY THE COMPONENT. (B)(4).

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT TECH TRIED TO GET A PATIENT IMAGE WHICH WAS TAKEN BY MOBILE X-RAY SYSTEM WITH CANNON CXDI-70. HOWEVER, THERE WAS A FAILURE TO LOAD THE IMAGE RESULTING IN GETTING A BLANK IMAGE. THE PATIENT HAD THE IMAGE RETAKEN BY ANOTHER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171122 SHIMADZU MOBILEDART EVOLUATION MOBILE X-RAY SYSTEM OWB SHIMADZU CORP. MOBILEDART EVOLUTIO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK