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

Model Number 10742326

Device Problem Program or Algorithm Execution Problem (4033)

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

Event Date 04/16/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens has completed the investigation of the reported event.The root cause was identified as a known issue.In the event any parameter has been modified for a scan which has been already loaded, the system does not trigger a cancel command and will not reload the scan with the new parameters.This defect, associated trend complaint number and details were reported to the fda on (b)(6) 2020 as part of the initial recall report for ct057/20/s, res# 8707, z-0771-2021.Upon further review of this case, it was determined that this event is mdr reportable event.The technical solutions have been implemented via system software updates vb20a_sp3 via ct056/20/s and vba20_sp4 via ct087/20/s and the issue has been resolved.

Event Description

It was reported to siemens that during a contrast enhanced dual energy head-neck scan of an (b)(6) male patient, the scan started too early without the planned delay of 13 seconds.Since the contrast enhancement was not sufficient during the early scanning, the scan was immediately repeated by the operator without any additional contrast media needed.Aside from the additional x-ray dose from the repeated scan, no patient injury was reported to siemens.This report has been filed with an abundance of caution.

• Brand Name: SOMATOM FORCE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 11807964
• MDR Text Key: 250846261
• Report Number: 3004977335-2021-77220
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869006956
• UDI-Public: 04056869006956
• 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,health
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/11/2021

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
• Device Operator: Health Professional
• Device Model Number: 10742326
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/10/2021
• Initial Date FDA Received: 05/11/2021
• 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
• Removal/Correction Number: Z-0771-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 11 YR