BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSOUND F-75

    MDR report key: 13687003 · Received March 8, 2022

    Report

    Report Number
    1528028-2022-00013
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    August 5, 2021
    Report Date
    March 7, 2022
    Manufacturer
    FUJIFILM HEALTHCARE CORPORATION
    Product Code
    IYN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON AUGUST 05, 2021, FUJIFILM HEALTHCARE AMERICAS CORPORATION (FORMERLY HITACHI HEALTHCARE AMERICAS CORPORATION) RECEIVED A COMPLAINT REGARDING PROSOUND F-75. THE SITE REPORTED THAT IT TOOK 10-15 MINUTES FOR THE SYSTEM TO BOOT UP AND WHEN IT FINALLY DID, THE IMAGE WAS BLACK. THEY ATTEMPTED TO REBOOT THE SYSTEM AND THE ISSUE PERSISTED. THE PATIENT WAS UNDER ANESTHESIA DURING TROUBLE SHOOTING PROCESS AND THE PROCEDURE WAS CANCELLED. 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
    1287519 PROSOUND F-75 PROSOUND F-75. IYN FUJIFILM HEALTHCARE CORPORATION N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other