MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION ARIETTA 850

Model Number	N/A
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, fujifilm healthcare americas corporation received a complaint regarding the arietta 850 ultrasound system.The site reported that they suddenly lost ability to use the panel buttons.The screen was grayed out, except for the probe select and the patient data buttons.They reselected the probe and were able to complete the procedure successfully.There was no impact or injury to the patient reported.There is no death or serious injury associated with this event.This issue was initially identified as a non-reportable event.During a retrospective review, it was determined that this complaint should be reported in an abundance of caution.

• Brand Name: ARIETTA 850
• Common Device Name: ARIETTA 850
• Manufacturer (Section D): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi; chiba-ken 277-0 804; JA 277-0804
• MDR Report Key: 14286404
• Report Number: 1528028-2022-00033
• Device Sequence Number: 20154602
• Product Code: IYN
• UDI-Device Identifier: 04573596214046
• UDI-Public: (01)04573596214046(11)220113
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2022

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: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/04/2022
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown