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

Model Number 10091805

Device Problems Use of Device Problem (1670); Data Back-Up Problem (2902)

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

Event Date 07/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation of the reported issue showed that the user's it group did not maintain their server environments with the available ms security patches designed for the wannacry virus as recommended by siemens in the update instruction sy027/17/s.The historical image studies are considered to be unrecoverable at this point of time.The syngo dynamics product did not cause or contribute to the loss of data.

Event Description

It was reported that the radiology server at the medical facility was infected by the wannacry virus.The sever was down for three weeks with no request from the user for recovery assistance.It was determined that the user no longer has the historical study images available if a comparison with newer images is desired.However, the previous clinical study reports generated from the read of the image studies are available in the syngo dynamics for clinical comparison.There was no injury associated with this issue.No data mix-up or loss occurred which result in the need for a patient would rescan.

• Brand Name: SYNGO DYNAMICS
• 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: 8560512
• MDR Text Key: 153977226
• Report Number: 3002808157-2017-87041
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102150
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/06/2017

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: 10091805
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/02/2017
• Initial Date FDA Received: 04/29/2019
• 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