BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FDR GO

    MDR report key: 22174295 · Received June 10, 2025

    Report

    Report Number
    1000513161-2025-00020
    Event Type
    Injury
    Date Received
    June 10, 2025
    Date of Event
    May 20, 2025
    Report Date
    June 9, 2025
    Manufacturer
    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
    Product Code
    IZL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REF. COMP # (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2025, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING FDR GO PORTABLE X-RAY SYSTEM. ON (B)(6) 2025, A FUJIFILM ENGINEER WAS SERVICING THE FDR GO FOR A BATTERY CHARGING ISSUE. AN ELECTRICAL ARC WAS DISCHARGED WHILE SWAPPING OUT A CIRCUIT BOARD. THE ENGINEER SUSTAINED 1ST, 2ND, AND 3RD DEGREE BURNS TO THE RIGHT HAND (INDEX AND MIDDLE FINGER) WHICH REQUIRED DEBRIDING AND OVERNIGHT HOSPITALIZATION FOR OBSERVATION. ON (B)(6) 2025, FUJIFILM TEAM ARRIVED AT THE CUSTOMER SITE TO INVESTIGATE THE INCIDENT, REVIEW SERVICING PRACTICES, ASSIST WITH TAKING APART THE FDR GO AND IMPLEMENT CORRECTIVE ACTIONS. THE INJURED ENGINEER STATED HE WAS REPLACING A POWER BOARD WHEN IT EXPLODED IN HIS HANDS. A FUJIFILM COWORKER HEARD A LOUD POP AND SAW THE INJURED ENGINEER ON THE GROUND WITH BURNS TO THEIR HAND. BOTH FUJIFILM EMPLOYEES STATED SERVICE WORK WAS PERFORMED ACCORDING TO FUJIFILM FDR GO SERVICE PROCEDURE AND IT WAS UNPLUGGED DURING SERVICING. ON (B)(6) 2025, ANOTHER FUJIFILM TEAM VISITED THE SITE TO ASSIST WITH CONTINUED INVESTIGATION OF THE POTENTIAL CAUSES. THE TEAM OBSERVED SIGNIFICANT BURN MARKS ON THE CIRCUIT BOARD. PHOTOS WERE TAKEN FROM ALL ANGLES. DISASSEMBLY THE FDR GO AND CONTINUITY CHECKS WHEN SYSTEM WAS TURNED ON OR OFF. THIS INCLUDED BATTERY VOLTAGE CHECKS, BREAKER INSPECTION, AND TESTS FOR ELECTRICAL SHORTS. ALL FUSES AND CAPACITORS WERE VERIFIED TO BE INTACT. THIS REPORT IS BEING SUBMITTED DUE TO THE CONFIRMED INJURY TO THE SERVICE ENGINEER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318330 FDR GO SYSTEM, X-RAY, MOBILE IZL SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION FDR GO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other