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

Model Number 10431700

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

Patient Problems Cardiac Arrest (1762); Hypersensitivity/Allergic reaction (1907)

Event Date 11/11/2022

Event Type  Death  

Event 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.

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
• 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: 15832965
• MDR Text Key: 303991115
• Report Number: 3004977335-2022-52830
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869006970
• UDI-Public: 04056869006970
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10431700
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/11/2022
• 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 Sex: Female