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

Model Number 0863172

Device Problems Use of Device Problem (1670); Loss of Data (2903); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

Possibility to recover data from the encrypted lts is currently being assessed by siemens.However, with currently available information, it can be confirmed that the syngo.Plaza system did not contribute to the data loss.

Event Description

Siemens became aware of a ransomware virus attack on the syngo.Plaza server.The name of the virus is unknown; however, it comes from the family of ransomware viruses.The syngo.Plaza server was not infected, only the files accessible through samba (smb) shares were encrypted as a result of the attack.The virus attacked the syngo.Plaza through the clients or other computers in the network.At the time of the attack the antivirus was not installed on the syngo.Plaza server.Access to share was not limited as recommended by the syngo.Plaza product documentation as it was set with permission to "everyone" with "read, write, execute".The attack resulted in 310,075 sops (service object pairs) in the sts (short term storage) to be encrypted.These sops belong to 50,504 series (fully or partially affected) out of 665,628 stored series in the sts.Multiple separate lts (long term storage) systems were affected by this attack as well.This incident occurred in (b)(6).

• Brand Name: SYNGO.PLAZA
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 16; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkestrasse 16; erlangen, 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd, mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 8532094
• MDR Text Key: 153112483
• Report Number: 3002808157-2018-55625
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K132532
• 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: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0863172
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other