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

Model Number	11061640
Medical Device Problem Code	Failure to Select Signal (1582)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to siemens that the mobile tablet associated with the somatom go.Top lost its wireless connection to the ct scanner during an interventional biopsy procedure on (b)(6) 2021.The pancreas biopsy was continued without the optional tablet, using the console of the scanner instead.Furthermore, it was reported that the user didn't use the measurement function at the scanner console.The distance that needed to be measured had been assessed visually only.The inaccuracy of this method resulted in additional and unnecessary patient bleeding.Aside from the additional blood loss, the patient did not suffer any negative health consequences.It was decided that the patient should stay one additional day at the hospital for monitoring.The patient was discharged after the 24-hour follow-up examination in good health and without adverse symptoms.In a worse-case scenario, the patient bleeding could become life-threatening if the major vessels (e.G., aorta) was punctured.This event has been reported with an abundance of caution.The reported event occurred in (b)(6).
Additional Manufacturer Narrative
Siemens has initiated a technical investigation of the reported event.A first, the investigation pointed to use error.In such situations the procedure must be terminated or can be continued with the functionality provided at the scanner console.Nevertheless, the technical investigation will be completed to determine the root cause of the lost wireless communication.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
Siemens has completed the technical investigation of the reported event.The root cause of the issue was a problem in the license evaluation due to a failing query in the database.This appears to be a sporadic problem.After some rebooting of the system, the query works well and so does the licensing.An acceptable workaround is available as follows: after rebooting the system, the system functions as intended.At times, multiple reboots are needed.The tablet is an option only, as all functions are available at the system console as well.A change request has been initiated to evaluate a potential fix for the identified issue with a future service pack or software version.This improvement will be considered a device enhancement.

• Brand Name: SOMATOM GO.TOP
• Common Device Name: 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 19355 ; 6104486484
• MDR Report Key: 13042780
• Report Number: 3004977335-2021-07730
• Device Sequence Number: 5424321
• Product Code: JAK
• UDI-Device Identifier: 04056869151571
• UDI-Public: 04056869151571
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K211373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11061640
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown