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

Model Number N/A

Device Problems Improper or Incorrect Procedure or Method (2017); Inadequate User Interface (2958)

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

Event Date 12/29/2020

Event Type  Injury  

Manufacturer Narrative

Unknown.The ef value is selected by the user via a drop-down menu.Once the drop-down menu has been selected, the ef value can be changed by the up and down arrow keys.The user did not change focus from the drop-down menu in the advanced reporting window to the viewer window before using the arrow keys in an attempt to move to the next image.This caused the selected ef value to unknowingly changed.If any additional relevant information becomes available, a supplemental report will be submitted.Ref: internal complaint number (b)(4).

Event Description

On (b)(6) 2021 fujifilm medical systems usa, inc.(fmsu) service department received a customer notification regarding an adverse event related to synapse pacs.Two reports changed from a qualitative ejection fraction (ef) value of 55-60% to one reported as <20%.The issue led to one patient receiving an unnecessary invasive coranary angio procedure.A second patient was unaffected because the error was caught prior to assessment.The patient has been reported to us as being healthy with no issues and was discharged.

• 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 27560
• MDR Report Key: 11185394
• MDR Text Key: 230339863
• Report Number: 3004972322-2021-00002
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00854904006008
• UDI-Public: (01)00854904006008(10)0700102
• Combination Product (y/n): N
• PMA/PMN Number: K190232
• 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
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 01/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other