MAUDE Adverse Event Report: FUJIFILM HEALTHCARE AMERICAS CORPORATION SYNAPSE PACS; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Model Number N/A

Device Problem Computer Software Problem (1112)

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

Event Date 08/16/2022

Event Type  malfunction  

Manufacturer Narrative

The reported issue was evaluated and replicated in the hcus lab, and the cause was traced to a software configuration.It is considered to be a rare occurrence in a clinical environment and highly detectable by a healthcare professional.

Event Description

On (b)(6) 2022, fujifilm healthcare americas corporation became aware of an event involving synapse pacs v7.1 that occurred on (b)(6) 2022.It was reported that the user experienced a patient mismatch issue between powerjacket and the viewer.There was no patient involvement reported.As such, this report is being submitted in an abundance of caution.

• Brand Name: SYNAPSE PACS
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): FUJIFILM HEALTHCARE AMERICAS CORPORATION; 3020 carrington mill blvd; suite 500; morrisville NC 27560
• Manufacturer (Section G): FUJIFILM HEALTHCARE AMERICAS CORPORATION; 3020 carrington mill blvd; suite 500; morrisville 27560
• Manufacturer Contact: randy vader ; 3020 carrington mill blvd; suite 500; morrisville, NC 27560
• MDR Report Key: 15486165
• MDR Text Key: 306350517
• Report Number: 3004972322-2022-00003
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00854904006008
• UDI-Public: (01)00854904006008(10)0701000
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K190232
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• 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: 09/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1