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

Model Number	10431700
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hypersensitivity/Allergic reaction (1907)
Date of Event	11/11/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom drive ct system.It was reported that a female patient was scheduled for a ct scan with contrast medium.After the contrast medium injection, the patient developed dyspnea and soon after required cpr for approximately 45 minutes.The hospital reported that the patient died.Although the patient most likely died due to an allergic reaction to the contrast medium, a technical investigation was initiated.The log files from three weeks prior to the event up to (b)(6) 2022, were analyzed.No scan aborts were detected on (b)(6) 2022, only during resume which was initiated by the customer.Twenty-six patients were scanned on (b)(6) 2022, without any problems.No scan aborts were detected in the period from (b)(6) 2022, either.Based on the available information, the death of the patient was not related to the somatom drive ct system.
Additional Manufacturer Narrative
According to the technical investigation, the ct system worked as specified.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.Based on the available information, the death of the patient was not related to the somatom drive ct system.

• Brand Name: SOMATOM DRIVE
• 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: 15832965
• Report Number: 3004977335-2022-52830
• Device Sequence Number: 12270803
• Product Code: JAK
• UDI-Device Identifier: 04056869006970
• UDI-Public: 04056869006970
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 11/21/2022

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: 10431700
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 11/21/2022
• 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 Sex: Female