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

Model Number 10590000

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2021

Event Type  malfunction  

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 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
• 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 19355 ; 6104486484
• MDR Report Key: 11363271
• MDR Text Key: 234329193
• Report Number: 3004977335-2021-65339
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869006949
• UDI-Public: 04056869006949
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10590000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/25/2021
• 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
• Patient Age: 40 YR
• Patient Weight: 61