MAUDE Adverse Event Report: SYNAPSE PACS

Model Number N/A

Device Problem Computer Software Problem (1112)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information: unknown.The issue was evaluated and replicated in the fmsu 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.If any additional relevant information becomes available, a supplemental report will be submitted.Ref: internal complaint number (b)(4).

Event Description

On november 09, 2020 fujifilm medical systems usa, inc.(fmsu) service department received a customer inquiry for assistance with synapse pacs powerjacket.The powerjacket window can become out of sync and display the details for the previously loaded patient.On november 25, 2020 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.

Manufacturer Narrative

Fujifilm initiated a recall on 03/02/2021 to alert customers of several patient mismatch issues existing in all synapse pacs 5 versions up to 5.7.210.Fujifilm submitted c&r report (1000513161-03/11/2021-001-c) to the fda, which was classified as class ii and assigned recall number z-1348-2021 on 04/02/2021.No further investigation is necessary.

• Brand Name: SYNAPSE PACS
• Type of Device: SYNAPSE PACS
• MDR Report Key: 11056905
• MDR Text Key: 243967264
• Report Number: 3004972322-2020-00009
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00854904006008
• UDI-Public: (01)00854904006008(10)0507200
• Combination Product (y/n): N
• PMA/PMN Number: K160108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: SEE H10
• Patient Sequence Number: 1