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

Model Number 11330003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 08/24/2022

Event Type  Death  

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 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.

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
• Type of Device: 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
• MDR Text Key: 298763346
• Report Number: 3004977335-2022-42132
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869263168
• UDI-Public: 04056869263168
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K220814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 11330003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 08/29/2022
• Supplement Dates Manufacturer Received: 09/30/2022
• Supplement Dates FDA Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 45 YR
• Patient Sex: Male