BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FDR GO

    MDR report key: 6010397 · Received October 7, 2016

    Report

    Report Number
    2443168-2016-00012
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    September 7, 2016
    Report Date
    October 7, 2016
    Manufacturer
    SHIMADZU CORPORATION
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER REPORTED THAT WHEN THEY PLUGGED THE FDR GO MOBILE X-RAY SYSTEM IN THERE WAS A LARGE SPARK AND THE PLUG SEPARATED FROM THE POWER CORD. NO ONE WAS HURT BY THE PLUG SPARKING. THE USER ALSO REPORTED THAT THE PLUG WAS HOT WHEN THEY UNPLUGGED AT THE START OF THE DAY (UNITS ARE TYPICALLY PLUGGED IN TO CHARGE OVERNIGHT. THE SYSTEM WAS ON WHEN HE PLUGGED IN THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663272 FDR GO MOBILE X-RAY SYSTEM IZL SHIMADZU CORPORATION FDR GO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1