BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FDR GO

    MDR report key: 15787523 · Received November 14, 2022

    Report

    Report Number
    1000513161-2022-00019
    Event Type
    Malfunction
    Date Received
    November 14, 2022
    Date of Event
    October 23, 2022
    Report Date
    November 14, 2022
    Manufacturer
    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING FDR GO. IT WAS REPORTED THAT THE UNIT UNEXPECTEDLY POWERED OFF AND THE USER NOTICED A BURNING SMELL. THE MACHINE WAS UNABLE TO BE POWERED BACK ON FOR SOME TIME CAUSING MULTIPLE PATIENT IMAGING DELAYS. THE SOURCE OF THE BURNING SMELL WAS DUE TO BLOWN FUSES IN THE PANEL, HOWEVER, THE CAUSE OF THE BLOWN FUSES IS UNKNOWN. THERE IS NO DEATH OR KNOWN SERIOUS INJURY ASSOCIATED WITH THE EVENT. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374566 FDR GO SYSTEM, X-RAY, MOBILE IZL SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown