MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH-CT NAEOTOM ALPHA; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	11330003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	08/24/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the naetom alpha ct system.Siemens was notified that a patient with a suspected pulmonary embolism could not be scanned on (b)(6) 2022.The patient passed away, although, the exact time of death is unknown at the time.During initial analysis, the siemens service specialist found that no valid customer scan protocol for pulmonary embolism with contrast agent was available.A technical investigation has been started to determine whether the ct scanner or the contrast agent injector (3rd party device) may have contributed to the event.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.On site analysis of the naeotom alpha ct system was conducted by a siemens healthineers engineer.The planned contrast-scan protocol selected by the customer for the user-specific examination was not available.It was reconstructed based on logfiles showing this specific protocol was deleted by the user on july 27, 2022.As a result, the user-specific and predefined examination was made useless and caused an applicable error message.Based on the technical investigation and according to the assessment from our medical experts, the ct system works as specified and the device did not cause or contribute to the patient's death.

• Brand Name: NAEOTOM ALPHA
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1 -or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1 -or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 15309899
• Report Number: 3004977335-2022-42132
• Device Sequence Number: 2658140
• Product Code: JAK
• UDI-Device Identifier: 04056869263168
• UDI-Public: 04056869263168
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K220814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2022

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: 11330003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 10/03/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 45 YR
• Patient Sex: Male