MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION SUPRIA TRUE64 WHOLE-BODY X-RAY CT SYSTEM; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number	N/A
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, fujifilm healthcare americas corporation received a complaint involving the supria true64 whole-body x-ray ct system.The event described in this report occured twice in one day during two different patient studies.This report addresses the first of the two events.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.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: SUPRIA TRUE64 WHOLE-BODY X-RAY CT SYSTEM
• Common Device Name: 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: 15154116
• Report Number: 1528028-2022-00055
• Device Sequence Number: 14783130
• Product Code: JAK
• UDI-Device Identifier: 04580292766601
• UDI-Public: (01)04580292766601(11)200130(250)G1Z0098019
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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: 07/21/2022
• Device Age: 30 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown