MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SYNGO.PLAZA; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Model Number 10863171

Device Problems Use of Device Problem (1670); Loss of Data (2903)

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

Event Date 01/09/2018

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report as per fda on 4/3/2019.Activities are ongoing to evaluate the exact amount of affected studies and the possibility of restoring them.No issue from syngo.Plaza software since syngo.Plaza did not contribute to the data loss at the site.No consequences have been reported, neither from this customer nor from the installed base.(b)(6).

Event Description

Per the potential complaint report, there was no injury associated with this issue.No mix-up occurred, hence, no patient rescan was required.Customer reported that certain studies cannot be found in syngo.Plaza patient browser.The system was migrated and upgraded from an old syngo.Plaza version to a new server and new sw version vb20a in (b)(6) 2017.During the analysis of this issue it has been identified that an incorrect license file is present on the system.Thus studies were not archived to syngo.Plaza's long term archive.The affected studies were present in the online storage for reporting of current examinations.After a certain fill level was reached in the online storage, the studies were removed by autodeletion function.The affected studies range from 01/2017 to 07/2017 and are not available for prior comparison.The reported event occurred in (b)(6).

• Brand Name: SYNGO.PLAZA
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 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 19355 ; 6104486478
• MDR Report Key: 8560715
• MDR Text Key: 162362491
• Report Number: 3002808157-2018-12788
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K093612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/12/2018

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
• Device Model Number: 10863171
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other