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

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	03/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, fujifilm healthcare americas corporation became aware of an event involving synapse pacs v7.1.It was reported that a measurement issue occurred while measuring a pediatric catheterization image.There was no patient involvement reported.As such, this report is being submitted in an abundance of caution.

• Brand Name: SYNAPSE PACS
• Common Device Name: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): FUJIFILM HEALTHCARE AMERICAS CORPORATION; 79 tw alexander dr.; bldg. 4501, ste. 300; durham NC 27709
• Manufacturer (Section G): FUJIFILM HEALTHCARE AMERICAS CORPORATION; 79 tw alexander dr.; bldg. 4501, ste. 300; durham NC 27709
• Manufacturer Contact: randy vader ; 79 tw alexander dr.; bldg. 4501, ste. 300; durham, NC 27709 ; 3603566821
• MDR Report Key: 16791846
• Report Number: 3004972322-2023-00001
• Device Sequence Number: 17501738
• Product Code: LLZ
• UDI-Device Identifier: 00854904006008
• UDI-Public: (01)00854904006008(10)0701000
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K160108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown