BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSOUND F-75

    MDR report key: 13689114 · Received March 8, 2022

    Report

    Report Number
    1528028-2022-00005
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    September 9, 2020
    Report Date
    March 7, 2022
    Manufacturer
    FUJIFILM HEALTHCARE CORPORATION
    Product Code
    IYN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2020, FUJIFILM HEALTHCARE AMERICAS CORPORATION (FORMERLY HITACHI MEDICAL SYSTEMS AMERICA, INC.) RECEIVED A COMPLAINT REGARDING PROSOUND F-75. THE SITE REPORTED THAT THE SYSTEM WAS NOT BOOTING UP CORRECTLY DURING A PROCEDURE. THE PATIENT WAS UNDER ANESTHESIA DURING THE TROUBLESHOOTING PROCESS. THE SYSTEM DID NOT BOOT AND AS A RESULT THE PROCEDURE WAS CANCELLED. COMPANY'S SERVICE DEPARTMENT RECEIVED A CALL AND AN ENGINEER WAS DISPATCHED TO THE SITE. THE ENGINEER REPLACED THE HARD DRIVE AND OPERATION PANEL CONTROL. THE SYSTEM WAS OPERATING AS INTENDED AFTER THE SERVICE CALL. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH EVENT. DURING A RETROSPECTIVE REVIEW, IT WAS DISCOVERED THAT THE MANUFACTURER HAD ASSESSED THIS EVENT AS AE LEADING TO SERIOUS INJURY; THEREFORE AN IMPORTER'S MDR IS BEING SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364173 PROSOUND F-75 PROSOUND F-75. IYN FUJIFILM HEALTHCARE CORPORATION N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other