MAUDE Adverse Event Report: FUJIFILM CORPORATION ARIETTA 50; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	ARIETTA 50
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We determined that this issue, which occurred during catheter insertion, could potentially lead to health risks such as vascular or organ damage.We are currently collecting and analyzing the device's log data.We have not received any reports of this incident recurring.
Event or Problem Description
When the physician was inserting a central venous catheter into a patient, the power of arietta 50 was being used to monitor the catheter's placement suddenly shut down.The physician temporarily paused the procedure, turned arietta 50 back on, and, since it restarted successfully, resumed the procedure, which was completed without incident.No harm to the patient's health occurred.

• Brand Name: ARIETTA 50
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): FUJIFILM CORPORATION; 3-1-1 higashikoigakubo; kokubunji-shi; tokyo, 185-0 014; JA 185-0014
• Manufacturer (Section G): FUJIFILM CORPORATION; 3-1-1 higashikoigakubo; kokubunji-shi; tokyo, 185-0 014; JA 185-0014
• Manufacturer Contact: 3-1-1 higashikoigakubo; kokubunji-shi; tokyo, 185-0-014
• MDR Report Key: 25226289
• Report Number: 3019784575-2026-00003
• Device Sequence Number: 9810423
• Product Code: IYN
• UDI-Device Identifier: 04573596213971
• UDI-Public: (01)04573596213971(11)220117
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K220295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ARIETTA 50
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown