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

Model Number 11061628

Device Problem Application Program Version or Upgrade Problem (2881)

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

Event Date 07/14/2020

Event Type  malfunction  

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 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
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, pa ; 4486484
• MDR Report Key: 10333382
• MDR Text Key: 205009619
• Report Number: 3004977335-2020-38487
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869051321
• UDI-Public: 04056869051321
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K200524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11061628
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/16/2020
• 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