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

Model Number	N/A
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3004972322-2022-00003
• Device Sequence Number: 7848159
• Product Code: LLZ
• UDI-Device Identifier: 00854904006008
• UDI-Public: (01)00854904006008(10)0701000
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K190232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/26/2022

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: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 09/26/2022
• 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: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown