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

Model Number 8162815

Device Problem Computer Operating System Problem (2898)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A thorough investigation into the reported issue is being conducted and a supplemental report will be submitted upon completion.Customer address: (b)(6).

Event Description

Siemens was notified on (b)(6) 2017 that the user reported a potential wrong lateral table offset value was shown in the adaptive targeting tab on rt therapist.The customer noticed the large offset of 2 cm before applying the shifts for patient positioning prior to patient treatment.Therefore the user acquired a second cone beam ct and checked the new offset value.The new offset value was plausible.There is no report of injury or mistreatment to the patient.This reported issue occurred in (b)(6).

Manufacturer Narrative

Exemption number e2017019.(b)(4).Siemens was not provided the requested information from the customer and the root cause of the reported issue could not be identified.A second issue was reported by the customer on (b)(6) 2017 that was similar in description.Requested information was provided and siemens has concluded that the customer's system was running on rt therapist 4.3.1_mr2, which has a known issue regarding the offset calculation when using multiple isocenter treatment plans.Siemens distributed a customer safety notice (th011/15/s) in regard to the reported issue that was delivered to the customer on (b)(6) 2017, making them aware of the issue.Depending on the user's workflow and whether they are aware of a mis-calculated offset, there is the possibility of critical injury to a patient due to dose delivery to the wrong treatment location and siemens has disclosed this information to the customer.The fix for the issue is available under update instruction th004/16/s, however, the customer has refused the update.Logfiles and software evaluation.

• Brand Name: SYNGO RT THERAPIST
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; advanced therapy; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; advanced therapy; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mc: 65-1a; malvern, PA 19355-9998 ; 6104486471
• MDR Report Key: 6818021
• MDR Text Key: 83634887
• Report Number: 3002466018-2017-93091
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K103606
• 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,Followup
• Report Date: 10/31/2017,08/23/2017

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2017
• Distributor Facility Aware Date: 08/23/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2017
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 08/24/2017
• Supplement Dates Manufacturer Received: 10/26/2017
• Supplement Dates FDA Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1