MAUDE Adverse Event Report: FUJIFILM HEALTHCARE AMERICAS CORPORATION SYNAPSE PACS; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Model Number	SYNAPSE SOFTWARE
Medical Device Problem Codes	Incorrect Measurement (1383); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint number (b)(4).Fujifilm healthcare americas corporation is conducting a voluntary correction for synapse pacs v7.4.Here is the initial investigation.Patient age at study time is as an important information when rendering a diagnosis and treatment plans.The age should be computed correctly and displayed using the following conditions: in days for patients less than 3-month-old, in month for patients between the ages of 3 to 36 months, in years and month for patients the age of 3 years to 18 years, in years for patients older or equal 18 years.Review of the complaints found that the age is incorrectly calculated and displayed for patients less than 3 months old under the following condition: the patient was born in the prior year of the study being taken and is less than 3-month-old.The issue is not restricted to patients less than 3 month.The issue can also happen for small children.For small children the wrong age would be displayed in month instead of days.The incorrect value can be off in the range of minus values up to a few month.The minus value display can be detected very easily as reported but any positive incorrect values may not be detectable by the radiologist or cardiologist.The issue presents itself only on the synapse pacs vx image viewer component.Any other component including but not limited to the zero viewer, thin viewer, series viewer are correct.Clinical impact: the diagnosis and/or the treatment plans could be incorrect for infants or small children.The likelihood of this issue happening is high (probable).
Event or Problem Description
On (b)(6) 2025, fujifilm healthcare americas corporation became aware of a product problem involving with synapse software version 7.4.2.It was reported that the patient's age is showing as one month earlier than it should be on pediatric studies in the vx viewer.Scrolling through the images sometimes fixes the issue.This happens on multiple workstations, both in the production and test environment.The image sender is missing in swat's overlay and using the default text overlay.

• Brand Name: SYNAPSE PACS
• Common Device Name: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): FUJIFILM HEALTHCARE AMERICAS CORPORATION; 81 hartwell avenue; suite 300; lexington MA 02421
• Manufacturer (Section G): FUJIFILM HEALTHCARE AMERICAS CORPORATION; 81 hartwell avenue; suite 300; lexington MA 02421
• Manufacturer Contact: randy vader ; 81 hartwell avenue; suite 300; lexington, MA 02421 ; 3603566821
• MDR Report Key: 21273940
• Report Number: 3004972322-2025-00002
• Device Sequence Number: 8080633
• Product Code: LLZ
• UDI-Device Identifier: 00854904006008
• UDI-Public: (01)00854904006008(10)0704200
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K190232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 01/30/2025

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: SYNAPSE SOFTWARE
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown