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

Model Number	10742326
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	04/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed if additional information becomes available.
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom force ct system.It was reported that after an 87-year-old female patient was positioned on the table and prepared for cardio scans, the system hung up and was not able to start the scan.The operator had to hard reset the machine twice.During the system reset, the patient collapsed, and resuscitation attempts were initiated.Even though the cardiologist and the cardiac team were present on site, cpr was not successful, and the patient died.Currently it is unclear if the ct scanner caused or contributed to the patient's death.Siemens has requested additional information in order to conduct an investigation of the reported event.Therefore, this report has been submitted with an abundance of caution.A supplement report will be filed upon completion of the investigation.
Additional Manufacturer Narrative
Siemens completed a thorough investigation of the reported incident.When the incident occurred, the user performed a hard shutdown of the system before pulling logfiles, which resulted in incomplete system logging.Siemens collected all available logfiles of the reported event from the concerned system and tried thoroughly reproducing the issue in test labs.The issue was not reproducible at the lab, therefore, siemens made multiple appointments with the customer (on (b)(6) 2025), where siemens specialists attended the user performing similar cardiac examinations.The issue did not re-occur.The customer site has been monitored; however, no reoccurrences have been reported.Accordingly, our experts have not been able to determine a root cause for the potential system freeze.The ics (image control system) software was successfully re-installed to prevent the issue from re-occurring.The customer confirmed that a timely provision of images did not affect the treatment strategy.Therefore, there is no correlation between the patient's death and the failure of the scan.No systematic product issue could be identified.

• Brand Name: SOMATOM FORCE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 -or-; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 21949271
• Report Number: 3004977335-2025-00060
• Device Sequence Number: 8382380
• Product Code: JAK
• UDI-Device Identifier: 04056869006956
• UDI-Public: (01)04056869006956
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,Followup
• Report Date (Section B): 07/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 10742326
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Death
• Patient Age: 87 YR
• Patient Sex: Female