MAUDE Adverse Event Report: SIEMENS AG SYNGO MULTIMODALITY WORKPLACE; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/13/2016

Event Type  malfunction  

Manufacturer Narrative

**resubmission of initial report as per fda on (b)(6) 2020** our experts were able to reproduce the reported issue.The reported issue is under investigation and a supplemental report will be submitted if additional information becomes available.Customer's address: (b)(6).

Event Description

Siemens received feedback from the customer reporting that the displayed standard uptake value (suv) was incorrect during the case as it was not reconstructed from the very beginning.This occurred when the customer viewed the list mode reconstruction data with mi applications on the syngo multimodality workplace, which was installed on customer's biograph 40 unit.According to the customer, the displayed suv was wrong in the reported case as it was not being reconstructed from the very beginning.Incorrect suv may lead to a potential misdiagnosis and incorrect patient treatment.The reported issue occurred in (b)(6).

• Brand Name: SYNGO MULTIMODALITY WORKPLACE
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): SIEMENS AG; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, pa ; 4486478
• MDR Report Key: 5619402
• MDR Text Key: 204216338
• Report Number: 2240869-2016-30400
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/13/2016
• Initial Date FDA Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other