MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON S2000 ULTRASOUND SYSTEM; ULTRASOUND DEVICE

Model Number ACUSON S2000

Device Problems Computer Software Problem (1112); Computer System Security Problem (2899)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2017

Event Type  Injury  

Manufacturer Narrative

No ultrasound systems have been reported to be infected with the wannacry virus.However, there is the potential for the virus to affect these products and halt system functionality.The resulting harm to the patient would be a possible delay in a procedure for a sedated patient, a reinsertion of a transesophageal transducer or catheter, or repeat of a stress echo exam.A hot fix will be issued to patch vulnerable systems.These hot fixes will follow the december 2016 postmarket management of cybersecurity in medical devices from the fda guidance for 806 reportability.

Event Description

It was reported that the system experienced a blue screen during a non-invasive study.It is presumed that the network was infected with a "wannacry" virus.The system was disconnected from the network and the patients' study was completed on a different system.There was no patient adverse event reported.No additional information was provided.The "wannacry" virus is reportable event based on the potential for death or serious injury to occur.

Manufacturer Narrative

This supplemental report is being submitted to retract the medical device report (mdr) that was initially submitted on 06/16/2017.For this complaint, when it was originally received on 06/08/2017, the investigation had not been completed and therefore, it was initially classified as a safety issue to file an initial mdr in order to prevent a late report submission.It was not until a later investigation it became apparent that for s-family products, the wanna-cry virus can be introduced into the system only through service back-up and restore function.The port is closed for all network traffic for s-family products, therefore, the probability of harm is low.Based on these findings, this supplemental mdr is to correct the previously submitted report which stated this issue could cause harm.

• Brand Name: ACUSON S2000 ULTRASOUND SYSTEM
• Type of Device: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view CA 94043 4050
• Manufacturer Contact: scott christiansen ; 685 east middlefield road; mountain view, CA 94043-4050 ; 4255571625
• MDR Report Key: 6648064
• MDR Text Key: 77788522
• Report Number: 3009498591-2017-00249
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ACUSON S2000
• Device Catalogue Number: 10041461
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other