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	01/04/2022
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.Synapse pacs (b)(4) was designed as the correction for the ongoing recall of synapse pacs versions (b)(4) to (b)(4) (z-1348-2021).(b)(4) reduced the risk of patient mismatch to a level that was deemed acceptable, and the company accepts that this issue may still occur at a remote frequency.If any additional relevant information becomes available, a supplemental report will be submitted.Ref: internal complaint number (b)(4).
Event or Problem Description
On 01/04/2022, 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 synapse pacs 5.7.230 patient mismatch issue occurred with desktop agent on lrmc radiology diagnostic workstation lrmcmd112177 (col (b)(6)).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.
Additional Manufacturer Narrative
Fujifilm initially determined that this incident was the same patient mismatch issue for which a recall is ongoing.However, upon receipt of additional information, it has been determined that this is an unrelated mismatch issue.It was discovered that too many studies were loaded onto the worklist, causing the worklist to refresh slowly.Because of the slow refresh, the user intended to open one study but another study was opened instead.The user manual includes a warning to not overload the worklist.This refresh problem would not cause a misdiagnosis because the worklist is used to navigate between studies but is not used for diagnosis.Ref: internal complaint number (b)(4).

• 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: 13307166
• Report Number: 3004972322-2022-00002
• Device Sequence Number: 19669607
• Product Code: LLZ
• UDI-Device Identifier: 00854904006008
• UDI-Public: (01)00854904006008(10)0507230
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

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: 01/04/2022
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2021
• 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: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown