MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SYNGO RT THERAPIST; ACCELERATOR, LINEAR, MEDICAL

Model Number 8162815

Device Problem Installation-Related Problem (2965)

Patient Problem No Patient Involvement (2645)

Event Date 05/21/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens has conducted a detailed technical investigation of the reported event.A root cause could not be determined.The customer service engineer re-installed the software and activated the embedded control.(b)(6).

Event Description

It was reported to siemens that during analysis of savelogs, customer service discovered the embedded control anti-virus software was not installed within the syngo.Rt therapist system.If the system remains unprotected the system might become infected by a virus which could cause in a worst case scenario, a mistreatment of moderate severity to a patient which would require medical treatment.No patient mistreatment or injury was reported to have occurred in relation to this issue.The reported event occurred in (b)(6).

• Brand Name: SYNGO RT THERAPIST
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486484
• MDR Report Key: 8670082
• MDR Text Key: 147067232
• Report Number: 3002466018-2019-82745
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8162815
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/21/2019
• Initial Date FDA Received: 06/05/2019
• 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: Reuse
• Patient Sequence Number: 1