MAUDE Adverse Event Report: SYNGO.VIA; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Model Number	10496180
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens stopped distribution of the affected software and is working on a corrective action for the reported issue.Internal id#: (b)(4).
Event or Problem Description
The reported issue was identified internally by siemens r&d department on the syngovia systems with version vb50 in the lungcad navigation tool.An incorrect nodule gets corrected in the lungcad navigation tool after accepting the currently edited nodule for the 2nd time.Correction focus does not switch to the new nodule and affects previous nodule, on which correction pen was invoked.As a result, incorrect information may contribute to medical diagnosis as a different nodule quantification is changed and it could lead to a wrong nodule assessment.Wrong nodule assessment may contribute to inadequate clinical patient management.The described issue is detectible to the user; however, the user may not realize that values had been changed for the accepted findings.

• Brand Name: SYNGO.VIA
• Common Device Name: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• MDR Report Key: 11728405
• Report Number: 3004977335-2021-76165
• Device Sequence Number: 3830887
• Product Code: LLZ
• UDI-Device Identifier: 04056869259802
• UDI-Public: 04056869259802
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K191040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2021

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: 10496180
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 04/26/2021
• 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: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other