BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FDR GO PLUS E

    MDR report key: 19091213 · Received April 11, 2024

    Report

    Report Number
    1000513161-2024-00025
    Event Type
    Malfunction
    Date Received
    April 11, 2024
    Date of Event
    March 27, 2024
    Report Date
    April 11, 2024
    Manufacturer
    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
    Product Code
    IZL
    UDI-DI
    04540217059379
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NM, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REF COMP (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2024 FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING FDR GO PLUS E. IT WAS REPORTED THAT THE PEDS ABDOMEN IS DEFAULTING TO ADULT ABDOMEN TECHNIQUES. THERE IS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1334210 FDR GO PLUS E SYSTEM, X-RAY, MOBILE IZL SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION FDR GO PLUS E UNKNOWN 04540217059379

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown