MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION ARIETTA 850

Model Number N/A

Device Problem No Display/Image (1183)

Patient Problem Insufficient Information (4580)

Event Date 03/18/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, fujifilm healthcare americas corporation received a complaint regarding the arietta 850 ultrasound system.The site reported that during the exam, the unit disconnected on its own from the scope and monitor went black with just the name on the top.The patient status has not been confirmed.As such, this event is being reported 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 277-0 704; JA 277-0704
• MDR Report Key: 14115945
• MDR Text Key: 289508628
• Report Number: 1528028-2022-00018
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/18/2022
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1