MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SOMATOM GO.UP; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	11061628
Medical Device Problem Code	Application Program Version or Upgrade Problem (2881)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is a siemens affiliate.Reporting facility telephone number is: (b)(6).Siemens investigated the reported event.This problem is related to the following software/workflow: syngo.Via rt image suite can be used as advanced application on somaris10 ct scanners.It offers the feature to do patient marking with an external laserbridge in conjunction with a ct scan for cancer treatment planning.To determine the correct mechanical distance between the laserbridge and the isocenter of the ct scanner gantry, the user must perform a new calibration and to record the measured "calibration offset parameter".All further actions will be reported to the fda separately as a voluntary recall action, starting with the customer safety advisory notice (csan) sy051/20/s.
Event or Problem Description
It was reported to siemens that due to a software problem, when the software version is updated from (b)(4), the "calibration offset parameter" which determines the distance between the external lasers for patient marking and the ct central image plane, is silently overwritten to the factory default settings (50.0cm).As of the date of this report, no injury has been reported to siemens.In a worst-case scenario, if the user doesn't realize this change and does not perform a re-calibration, this change may result in an incorrect patient marking and subsequently to a radiation dose applied to wrong location during the cancer treatment.This worst-case scenario can only occur if some other process steps such as, position verification at the linear accelerator before the treatment, do not clearly show any deviation.This problem is related to the following software/workflow: syngo.Via rt image suite can be used as advanced application on somaris10 ct scanners.The reported event occurred in (b)(6).

• Brand Name: SOMATOM GO.UP
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10333382
• Report Number: 3004977335-2020-38487
• Device Sequence Number: 3623825
• Product Code: JAK
• UDI-Device Identifier: 04056869051321
• UDI-Public: 04056869051321
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K200524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/28/2020

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
• Operator of Device: Health Professional
• Device Model Number: 11061628
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1