MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SOMATOM DEFINITION EDGE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	10590000
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has initiated a technical investigation of the reported event.The root cause has not yet been identified.A supplemental report will be submitted upon the completion of the investigation.
Event or Problem Description
It was reported to siemens that during an interventional procedure of an (b)(6) year- old female child (biopsy procedure), the software froze and did not respond.After the scanner was restarted successfully, the procedure was finished by scanning one additional topogram (low dose overview image), and three low dose spiral scans.No other injury has been reported to us, except the x-ray dose from the additional ct scans.This report has been filed with an abundance of caution.The reported event occurred in (b)(6).
Additional Manufacturer Narrative
Siemens completed the technical investigation of the reported event.Since a root cause of the software freeze could not be determined with the available logfiles, the siemens service engineer enabled trace files for additional logging at this system.The siemens local service engineer was not able to reproduce the error until 2/9/2021.Based on the available data, no general design issue was identified.If the complaint issue reoccurs with this system, a new complaint investigation will be opened.

• Brand Name: SOMATOM DEFINITION EDGE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 11011875
• Report Number: 3004977335-2020-56433
• Device Sequence Number: 4496855
• Product Code: JAK
• UDI-Device Identifier: 04056869006949
• UDI-Public: 04056869006949
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K190578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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: 10590000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 11 YR