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

Model Number N/A

Device Problem Computer Software Problem (1112)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2023

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 313816636
• Report Number: 3004972322-2023-00001
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00854904006008
• UDI-Public: (01)00854904006008(10)0701000
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• 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
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1