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	10/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported issue was evaluated and replicated in the hcus lab, and the cause was traced to a software configuration.It is considered to be a rare occurrence in a clinical environment and highly detectable by a healthcare professional.Fujifilm initiated a recall on march 2, 2021 to alert customers of several patient mismatch issues existing in all synapse pacs 5 versions.Fujifilm submitted c&r report 1000513161-03/11/2021-001-c to fda, which has been classified as class ii and has ongoing recall under recall number z-1348-2021.
Event or Problem Description
On october 6, 2022, fujifilm healthcare americas corporation became aware of an event involving synapse pacs v5.7.212.It was reported that the user experienced a patient mismatch issue between powerjacket and the viewer.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; 3020 carrington mill blvd; suite 500; morrisville NC 27560
• Manufacturer (Section G): FUJIFILM HEALTHCARE AMERICAS CORPORATION; 3020 carrington mill blvd; suite 500; morrisville 27560
• Manufacturer Contact: randy vader ; 3020 carrington mill blvd; suite 500; morrisville, NC 27560
• MDR Report Key: 15638949
• Report Number: 3004972322-2022-00005
• Device Sequence Number: 12229387
• Product Code: LLZ
• UDI-Device Identifier: 00854904006008
• UDI-Public: (01)00854904006008(10)0507212
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/20/2022

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: 10/06/2022
• Initial Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2021
• 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: SEE H10
• Patient Sequence Number: 1
• Patient Sex: Unknown