MAUDE Adverse Event Report: FUJIFILM MANUFACTURING SYNAPSE SELECT (VIDISTAR); SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Model Number	H305686
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ref (b)(4).The customer received production upgraded on 1/3/24 from fujifilm engineer via service support.
Event or Problem Description
It was reported that there is a data point there in between (b)(6) 2023.No echocardiogram was performed on patient during that time, therefore unknown source of synapse select (vidistar) data point.Unknown impact to patient.No additional information provided.
Additional Manufacturer Narrative
Ref (b)(4).Investigation concluded that the data point on the chart plot was not incorrect.Though it appeared that the chart spiked, it spiked correctly.The data point was an actual value from a prior report in their system for that patient that was charted.The actual measurement of the data point remains correct.The data point can come from a dicom sr send-to synapse select or be manually input via the report functionality.In either case, the cardiologist must sign off on the correctness of the value, which he did for the prior report.However, it was found that the data point was plotted forward in time, making it appear misplaced.The misplacement happened due to an issue discovered in how time zones and daylight savings time are handled.The misplacement of the data point is a minor issue since that will not impact the diagnosis.The customer comment on clinical care was that the value was "high," which made the chart appear spiked.There was no device issue, the data point was high and was supposed to show a high value.

• Brand Name: SYNAPSE SELECT (VIDISTAR)
• Common Device Name: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): FUJIFILM MANUFACTURING; 79 tw alexander dr bldg 4501,; suite 300,; durham NC 27709
• Manufacturer (Section G): FUJIFILM MANUFACTURING; 79 tw alexander dr bldg 4501,; suite 300,; durham, NC 27709
• Manufacturer Contact: randy vader ; 79 tw alexander dr bldg 4501,; suite 300,; durham,, NC 27709 ; 3603566821
• MDR Report Key: 18576449
• Report Number: 3004972322-2024-00001
• Device Sequence Number: 8925978
• Product Code: LLZ
• UDI-Device Identifier: 00869047000431
• UDI-Public: (01)00869047000431(11)231213(240)4.5.0.202312131507
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H305686
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown