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

Model Number	08098027
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation revealed that at 12:47, the ct system was not completely functional after a successful patient scan.The customer tried to run image reconstructions for approx.1.5 hours.The requested reconstructions were performed with a stroke head protocol, head and neck protocol and a pulmonary embolism (pe) study.Despite reports that multiple restarts did not solve the issue, only one reboot of the image reconstruction system (irs) was made at 14:13, although the patient had been closed and loaded several times.The scanner was operational again at 14:23.The patient was loaded again and reconstruction was finished at 14:49.The affected patient was loaded again at 16:12 and additional reconstructions were performed until 16:31.Based on our information the patient died at 16:40.During the investigation, the customer was contacted directly to clarify the reported situation.During this phone call on (b)(6) 2024, with a healthcare professional, the customer confirmed the described order of occurrences and confirmed that the device did not cause or contribute to patient's death.The patient was admitted to the hospital as exceptionally ill.Initial diagnosis was clinical cardio shock, acute hypoxic respiratory failure and multiple organ failures.The customer confirmed that even if the reconstructed data would have been available earlier, the patient would have died due to the severe health condition.The final technical investigation result shows that the simultaneous requested complex reconstructions, started by the customer, caused a very high system workload, resulting in the system delay.If the recommended restart of the system would have been made earlier, the reconstruction could have been finished earlier.As it is confirmed by the customer that the device did not cause or contribute the patient death and also the technical investigation did not show a systematic or design issue, this report is filed with an abundance of caution.
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom definition as ct system.On (b)(6) 2024, image reconstruction for an adult female emergency patient took very long.It was reported that the patient later died due to her severe health conditions.

• 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: 18655804
• Report Number: 3004977335-2024-00014
• Device Sequence Number: 6885086
• 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): 02/07/2024

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: 08098027
• Device Catalogue Number: 08098027
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female