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 Consequences Or Impact To Patient (2199)

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

The issue was evaluated and replicated in the fmsu lab.The cause was traced to a software configuration.A bug fix was developed and provided to fix the issue.If any additional relevant information becomes available, a supplemental report will be submitted.Ref: (b)(4).

Event Description

On june 26, 2020 fujifilm medical systems usa, inc.(fmsu) service department received a customer inquiry for assistance with synapse pacs powerjacket.When opening the powerjacket and selecting a patient off the worklist, the powerjacket displayed incorrect patient information.The doctor indicated that the issue occurred again when selecting another patient and the powerjacket again displayed a different patient.The fujifilm customer service representative did not identify any issues within the iis logs of the customer and the issue could not be reproduced.On july 08, 2020 a risk assessment was performed to investigate the risk to patient safety.There was no patient involvement, 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.

Manufacturer Narrative

Updated information is provided in section h7, h9, and h10 (additional narrative).Fujifilm initiated a recall on 9/11/2020 to correct the powerjacket issue by providing a software upgrade to synapse pacs 5.7.200us.C&r report (1000513161-09/17/2020-001-c) was submitted to the fda.On 01/16/2021, the recall was classified by fda as class ii and assigned the recall number z-0878-2021.No further investigation is necessary.

• Brand Name: SYNAPSE PACS
• Type of Device: SYNAPSE PACS
• Manufacturer (Section D): FUJIFILM MEDICAL SYSTEMS U.S.A., INC.; 3020 carrington mill blvd; ste 500; morrisville, nc
• MDR Report Key: 10376510
• MDR Text Key: 233710677
• Report Number: 3004972322-2020-00003
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00854904006008
• UDI-Public: (01)00854904006008(10)0505002
• 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: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• 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: 01/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: SEE H10
• Patient Sequence Number: 1