BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHIMADZU MOBILEDART EVOLUTION

    MDR report key: 3224486 · Received April 26, 2013

    Report

    Report Number
    8030233-2013-00002
    Event Type
    Other
    Date Received
    April 26, 2013
    Date of Event
    March 8, 2013
    Report Date
    April 26, 2013
    Manufacturer
    SHIMADZU CORP.
    Product Code
    IZL
    PMA / PMN Number
    K080701
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE ALREADY CONTACTED WITH THE USER FACILITY. THE ACTUAL RADIATION PARAMETER IS INDICATED ON THE DEVICE IN THIS CONDITION. THEREFORE, IF THE USER CONFIRM THE EXPOSURE CONDITION BEFORE EXPOSURE ACCORDING TO THE MANUAL, WE COULD AVOID THIS INCIDENT. WE EXPLAINED USER TO CONFIRM THEM. WE ARE STILL INVESTIGATION THE CAUSE OR THIS INCIDENT. WE WILL REPORT OUR CONCLUSION FOR THIS INCIDENT AS SOON AS POSSIBLE.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183341 SHIMADZU MOBILEDART EVOLUTION MOBILE X-RAY SYSTEM IZL SHIMADZU CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other