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

Model Number	08098027
Medical Device Problem Codes	Program or Algorithm Execution Problem (4033); Delayed Program or Algorithm Execution (4034)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthineers has requested additional information in order to conduct a thorough investigation of the reported event.Should the investigation identify a general design or systematic issue, or any other reason as a root cause of this issue, a supplemental report will be filed.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom definition as ct system.On (b)(6) 2023, a 14-year-old female, polytrauma patient was taken to the emergency department for a head, spine, and thorax examination.The head scan was completed successfully, however, due to a technical issue, the operator could not continue the planned spine and thorax examinations.The customer decided to transfer the patient to the radiology department where the spine and thorax examinations could be completed successfully with a delay of 20 minutes.It was reported that the patient passed away approximately five hours later.According to the customer, the delay in procedure did not cause nor contribute to the patient¿s death.The customer confirmed by phone that the patient death was directly related to the serious injuries caused by a traffic accident.This report is submitted with an abundance of caution.

• Brand Name: SOMATOM DEFINITION AS
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1~or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1~or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 17689016
• Report Number: 3004977335-2023-00106
• Device Sequence Number: 12291319
• Product Code: JAK
• UDI-Device Identifier: 04056869003665
• UDI-Public: 04056869003665
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K230421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/06/2023

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: 08098027
• Device Catalogue Number: 08098027
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Sex: Female