MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION ARIETTA 850

Model Number N/A

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2022

Event Type  malfunction  

Event Description

On may 20, 2022, fujifilm healthcare americas corporation received a complaint regarding the arietta 850 ultrasound system.The site reported that the image output is frequently black and the system must be rebooted for the images to reappear.The studies are able to continue following a system reboot.There is no death or serious injury associated with this event.As such, this report is being submitted in an abundance of caution.

• Brand Name: ARIETTA 850
• Type of Device: ARIETTA 850
• Manufacturer (Section D): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• MDR Report Key: 14551621
• MDR Text Key: 293086339
• Report Number: 1528028-2022-00044
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 04573596214046
• UDI-Public: (01)04573596214046(11)210903
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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: 05/20/2022
• Device Age: 8 MO
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1