BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FDR GO PLUS E

    MDR report key: 18326176 · Received December 14, 2023

    Report

    Report Number
    1000513161-2023-00083
    Event Type
    Malfunction
    Date Received
    December 14, 2023
    Date of Event
    November 16, 2023
    Report Date
    December 15, 2023
    Manufacturer
    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON NOVEMBER 16TH 2023 FUJIFILM CORPORATION WAS INFORMED OF AN EVENT INVOLVING FDR GO PLUS E IT WAS REPORTED THAT THE COLLIMATOR FELL OFF WHILE SCANNING A PATIENT, NO ONE WAS HURT. THEY FOUND TWO SCREWS MISSING AND A PLASTIC PIECE THAT IS BROKEN. MIKE FOUND ONE OF THE SCREWS AND PUT IT BACK ON BUT NEEDS SOMEONE TO COME OUT TO FIX AND SECURE THE COLLIMATOR. THERE IS NO PATIENT HARM OR INJURY REPORTED. THERE IS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327352 FDR GO PLUS E SYSTEM, X-RAY, MOBILE, PRODUCT CODE: IZL IZL SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION 16580911

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown