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

Model Number	08098027
Medical Device Problem Codes	Computer Software Problem (1112); Delayed Program or Algorithm Execution (4034)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom definition as ct system.On (b)(6) 2024, the customer stated that the scan of a stroke patient was not able to be performed.Therefore, the patient was transferred to another facility for scanning.The delay lasted approximately 90 minutes.No further patient information was provided by the customer and no negative health consequence was reported.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.Based on event log analysis it was determined that the patient scan could not be loaded because some scan parameters were evaluated by the system as invalid and needed to be corrected by the operator.Therefore, the load button was not enabled / usable for the customer and the examination could not be performed.The investigation of the tube history showed no abnormalities.Furthermore, the event log showed that another patient was successfully scanned approximately 15 minutes after the affected stroke patient.The customer has not reported this failure again.The investigation of the reported event has not identified a general design or systematic issue.

• 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., mc 65-1a; malvern, PA 19355 ; 4843231631
• MDR Report Key: 19392257
• Report Number: 3004977335-2024-00056
• Device Sequence Number: 7799941
• Product Code: JAK
• UDI-Device Identifier: 04056869003665
• UDI-Public: 04056869003665
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

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: 04/29/2024
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male