MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION SCENARIA¿ VIEW -128 SLICE CT SYSTEM; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number N/A

Device Problem Computer Software Problem (1112)

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

Event Date 03/25/2022

Event Type  malfunction  

Event Description

On march 25, 2022, fujifilm healthcare americas corporation received a complaint involving the scenaria view ct.It was reported that while performing a scanogram, an error occurred during a patient study.The error was due to specific search strings containing lowercase letters entered in the patient information fields.The images were not reconstructed because of the error and the rawdata was not displayed in the worklist.The patient was successfully scanned using another device.This issue was initially identified as non-reportable because there was no death, patient injury, or concern of overexposure associated with the event.However, fujifilm healthcare americas corporation was informed that the manufacturer initiated a recall on july 12, 2022 to correct this issue.As such, it was determined that this complaint should be reported in an abundance of caution.

• Brand Name: SCENARIA¿ VIEW -128 SLICE CT SYSTEM
• Type of Device: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• MDR Report Key: 15102705
• MDR Text Key: 296585676
• Report Number: 1528028-2022-00054
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04580292766694
• UDI-Public: (01)04580292766694(11)191220(250)G560052219
• 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: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• 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: 07/07/2022
• Device Age: 31 MO
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1