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 05/08/2022

Event Type  malfunction  

Event Description

On may 08, 2022 fujifilm healthcare americas corporation received a complaint regarding scenaria view ct.It was reported that one patient was scanned multiple times on 2 different devices at the same location over the period of two days.The error occurred while scanning patient information that contained specific words.Because of the error images weren't reconstructed and rawdata was not displayed.Due to this one patient was scanned multiple times.The patient was successfully scanned on this device, but on (b)(6) 2022 it was confirmed that the patient received 106.78 msv in radiation across the two days.Fujifilm healthcare americas corporation was informed that the manufacturer has initiated a recall on july 12, 2022 to correct this issue.There was no death or injury reported with this event.The other system involved in this incident is being reported under 1528028-2022-00051.

• 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 277-0 704; JA 277-0704
• MDR Report Key: 15074305
• MDR Text Key: 296300183
• Report Number: 1528028-2022-00050
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04573596200544
• UDI-Public: (01)04573596200544(11)210909(250)G1Z0128621
• 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: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• 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: 07/05/2022
• Device Age: 10 MO
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1