MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION ARIETTA 850

Model Number N/A

Device Problems Display or Visual Feedback Problem (1184); Visual Prompts will not Clear (2281); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 02/18/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, fujifilm healthcare americas corporation (formerly hitachi medical systems u.S.A., inc.) received a complaint regarding arietta 850 ultrasound.The site reported that the system booted up and was able to scan but then they lost the main image.The ultrasound system went dark.This incident occured while the patient was under anesthesia.The site was using another manufacturer's probe, an olympus linear probe uct180.The site was unable to get an image using a new maj cable and the procedure was aborted.Information regarding the type of procedure, patient information, or the status of the patient was not provided.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.

• 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: 13688763
• MDR Text Key: 291396362
• Report Number: 1528028-2022-00009
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 02/18/2021
• Device Age: 1 YR
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other