MAUDE Adverse Event Report: FUJIFILM MEDICAL SYSTEMS U.S.A. INC SYNAPSE PACS

Model Number N/A

Device Problem Computer Software Problem (1112)

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

Event Date 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

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.This issue was initially identified as a non-reportable event.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 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 Description

On 09/11/2019, 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 study for patient a, study details for patient b are displayed.There was no patient impact, serious injury or death associated with this event.The issue is considered highly detectable by a healthcare professional.

• Brand Name: SYNAPSE PACS
• Type of Device: SYNAPSE PACS
• Manufacturer (Section D): FUJIFILM MEDICAL SYSTEMS U.S.A. INC; 3020 carrington mill blvd; suite 500; morrisville NC 27560
• MDR Report Key: 12127987
• MDR Text Key: 263397209
• Report Number: 3004972322-2021-00011
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00854904006008
• UDI-Public: (01)00854904006008(10)0505000
• 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,foreig
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2018
• 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