MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG SEIMENS SOMATOM DEFINITION AS64; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 08098027

Patient Problem Insufficient Information (4580)

Event Date 01/07/2024

Event Type  Death  

Event Description

Patient arrived to our emergency department in acute distress; workup required to rule out multiple diagnosis.Most of which required several ct (computed tomography) imaging studies.While conducting several ct images and processes, the ct machine froze and the user lost control of the program/machine.This required the unit to be restarted which takes additional time to reboot.After which, the technician proceeded with the remaining studies, however the unit froze again, causing and additional delay.A repair ticket was placed with seimens at that time.Since, the ct machine has once again froze and was required to be rebooted; an additional ticket was placed at that time.Seimens repair technician informed the radiology leader that this may be a potential software issue.We have requested additional information, guidance, and a resolution from seimens, but have yet to receive feedback.Although this issue and the subsequent delay may not have changed the outcome for this particular patient, we feel this needs to be voiced as to identify if other cases have been reported.

• Brand Name: SEIMENS SOMATOM DEFINITION AS64
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; malvern PA 19355
• MDR Report Key: 18739678
• MDR Text Key: 335864848
• Report Number: MW5151767
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08098027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White