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 05/04/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, fujifilm healthcare americas corporation received a complaint involving the scenaria view ct.It was reported that while performing a double 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.As a result, the images were not reconstructed 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 (b)(6) 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: 15102698
• MDR Text Key: 296599064
• Report Number: 1528028-2022-00052
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04580292766694
• UDI-Public: (01)04580292766694(11)201020(250)G1Z0001220
• 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: 21 MO
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1