MAUDE Adverse Event Report: FUJIFILM HEALTHCARE AMERICAS CORPORATION SYNAPSE PACS; PICTURE ARCHIVING AND COMMUNICATION 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	07/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, fujifilm healthcare americas corporation became aware of a product problem involving synapse pacs v7.3.It was reported that there is an incorrect equation for lv mass (2d bullet) calculation.The formula that equates the mass of the left ventricle is incorrectly calculating the lv wall thickness causing the difference to vary depending on the amount of thickness that exists in the ventricle.Thicker lv walls will cause a larger difference in the results.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: PICTURE ARCHIVING AND COMMUNICATION SYSTEM
• Manufacturer (Section D): FUJIFILM HEALTHCARE AMERICAS CORPORATION; 79 tw alexander drive; building 4501, suite 300; durham NC 27709
• Manufacturer (Section G): FUJIFILM HEALTHCARE AMERICAS CORPORATION; 79 tw alexander dr.; building 4501, suite 300; durham NC 27709
• Manufacturer Contact: randy vader ; 79 tw alexander dr.; building 4501, suite 300; durham, NC 27709 ; 3603566821
• MDR Report Key: 17607600
• Report Number: 3004972322-2023-00002
• Device Sequence Number: 17713068
• Product Code: LLZ
• UDI-Device Identifier: 00854904006008
• UDI-Public: (01)00854904006008(10)0703000
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial

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: 07/24/2023
• Initial Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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