BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIETTA 850

    MDR report key: 13687462 · Received March 8, 2022

    Report

    Report Number
    1528028-2022-00012
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    July 29, 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 (B)(6) 2021, FUJIFILM HEALTHCARE AMERICAS CORPORATION (FORMERLY HITACHI HEALTHCARE AMERICAS CORPORATION) RECEIVED A COMPLAINT REGARDING ARIETTA 850 ULTRASOUND. THE SITE REPORTED THAT THE SYSTEM DISPLAYED A "PROBE NOT CONNECTED" ERROR MESSAGE THAT THEY WERE UNABLE TO CLEAR. THEY ATTEMPTED TO REBOOT THE SYSTEM TO CLEAR THE MESSAGE BUT SYSTEM WOULD NOT RESTART AFTER SHUTDOWN. THIS INCIDENT OCCURRED WHILE THE PATIENT WAS UNDER ANESTHESIA. THE PROCEDURE HAD TO BE ABORTED AND RESCHEDULED AT A LATER DATE. THERE WAS NO INJURY/HARM OR DEATH REPORTED WITH THIS 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
    1167052 ARIETTA 850 ARIETTA 850 IYN FUJIFILM HEALTHCARE CORPORATION N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other