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

Model Number	10590000
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter's telephone number is: (b)(6).Siemens completed a technical investigation of the reported event.Based on the event log, an application error could not be detected during the workflow.The operator did not perform a topogram and then performed the spiral scan and repeated it twice (three scans in total).This event was determined to be a user error since no system error was found in the available log files and a topogram was not performed.A savelog was not created by the user, therefore, a more detailed investigation is not possible.No general design issue or product malfunction were identified based on the available data and information.
Event or Problem Description
It was reported to siemens that during a pelvimetry ct examination of a (b)(6)-year-old, pregnant woman using the somatom definition edge system, an issue occurred requiring the patient to be rescanned.The customized scan protocol did not include a topogram (low dose overview image) and following spiral scan was planned and executed without the assistance of the topogram.The primary function of a topogram is to be the planning base for the subsequent spiral scan.After the spiral scan was performed, the operator realized that the acquisition images did not contain the entire area of interest and the patient had to be rescanned.According to the patient protocol, the patient was scanned three times with a dose-length product (dlp) of 21mgy-cm for each scan range, resulting in a total dlp of 63mgy-cm.There has been no report of patient or fetal injury as of the date of this report.This report has been submitted with an abundance of caution.The reported event occurred in (b)(6).

• 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: 11363271
• Report Number: 3004977335-2021-65339
• Device Sequence Number: 11050604
• 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
• Report Date (Section B): 02/22/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 61