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

Model Number 8098027

Device Problem Unintended Movement (3026)

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

Event Date 04/21/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens conducted a technical investigation of the reported event.From the provided dose protocol, it was determined that the scanned body area was the thorax.Siemens service specialists identified that the issue was caused by the patient movement during the examination.The system detected the unintended table movement and consequently stopped the acquisition.No device malfunction has been identified.No further action is warranted at this time.

Event Description

It was reported to siemens that during a chest ct examination of a pregnant woman, the gantry resumed during the contrast injection in the bolus tracking phase.The patient was rescanned (topogram and bolus tracking) and was reinjected with 90ml of contrast media ((xenetics 350).Aside from the additional x-ray dose and contrast media, no additional injury was reported.This report has been filed with an abundance of caution.The reported event occurred in (b)(6).

• Brand Name: SOMATOM DEFINITION AS
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 11847598
• MDR Text Key: 251389422
• Report Number: 3004977335-2021-78409
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869003665
• UDI-Public: 04056869003665
• Combination Product (y/n): N
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8098027
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/27/2021
• 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: 43 YR
• Patient Weight: 85