MAUDE Adverse Event Report: FUJIFILM HEALTHCARE AMERICAS CORPORATION SYNAPSE PACS

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	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The issue was evaluated and replicated in the hcus lab; the cause was traced to a software configuration.This issue is very rare and requires many tries with large studies to reproduce; it is considered to be a very rare occurrence in a clinical environment.This issue was initially identified as a non-reportable event.During a retrospective review, it was determined that this complaint should be reported in an abundance of caution.Fujifilm has initiated a recall on 3/2/2021 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.If any additional relevant information becomes available, a supplemental report will be submitted.Ref: internal complaint number (b)(4).
Event or Problem Description
On 04/14/2021, fujifilm healthcare americas corporation received a customer inquiry for assistance with synapse pacs.There was a issue noted is as follows: it was reported that the patient history did not refresh after study change.The previous patient information is displayed.There was no patient impact, serious injury or death associated with this event.The issue is considered highly detectable by a healthcare professional; however this report is being submitted in abundance of caution.

• Brand Name: SYNAPSE PACS
• Common Device Name: SYNAPSE PACS
• 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 NC 27560
• Manufacturer Contact: randy vader ; 81 hartwell avenue; suite 300; lexington, MA 02421-7838 ; 3603566821
• MDR Report Key: 13291402
• Report Number: 3004972322-2022-00001
• Device Sequence Number: 4599411
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 01/19/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• 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: Unknown
• 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