MAUDE Adverse Event Report: 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	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The issue was evaluated and replicated in the fmsu lab; the cause was traced to a software configuration.The issue was resolved after upgrading to version 5.7 and installing a software component that enhanced the cache management.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.If any additional relevant information becomes available, a supplemental report will be submitted.Ref: internal complaint number comp(b)(4).
Event or Problem Description
On (b)(6) 2019, fujifilm medical systems u.S.A., inc.(fmsu) received a customer inquiry for assistance with synapse pacs.There was an issue noted that is described below: when the user attempts to open a report for patient a, study details for patient b are displayed.This error is easily identified since name displayed does not match.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
• MDR Report Key: 12129429
• Report Number: 3004972322-2021-00019
• Device Sequence Number: 4411477
• Product Code: LLZ
• UDI-Device Identifier: 00854904006008
• UDI-Public: (01)00854904006008(10)0505000
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2021

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: 10/01/2019
• Initial Report FDA Received Date: 07/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2018
• 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