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	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The issue was evaluated and replicated in the (b)(6) 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 previously reported by the user on (b)(6) 2021, which was reported to the fda in 3004972322-2021-00007.The user site was upgraded from (b)(4), but the new patch did not correct the issue.Fujifilm 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 assigned 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 (b)(6) 2021 fujifilm medical systems usa, inc.(fmsu) was made aware of an incident with synapse pacs.A url call from ris results in a patient/study mismatch.On (b)(6) 2021 a risk assessment was performed to investigate the risk to patient safety.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: 11665957
• Report Number: 3004972322-2021-00008
• Device Sequence Number: 14227482
• Product Code: LLZ
• UDI-Device Identifier: 00854904006008
• UDI-Public: (01)00854904006008(10)0507212
• 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: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/14/2021

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: 04/01/2021
• Initial Report FDA Received Date: 04/14/2021
• 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: 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