MAUDE Adverse Event Report: SIEMENS AG/SIEMENS HEALTHCARE GMBH SENSATION 64; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number CT-SENSATION 64

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 05/19/2022

Event Type  malfunction  

Event Description

After contrast injection, the scan was loaded and began, but ct scanner cut off during the first slice.The scan was repeated but took only 3 slices before shutting off for the second time.The patient had to be moved to another scanner to finish the scan.This patient¿s same anatomy was scanned 3 times due to scanner malfunction.Patient was scanned at 5 minutes after contrast injection, so contrast bolus was lost.

• Brand Name: SENSATION 64
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS AG/SIEMENS HEALTHCARE GMBH; 40 liberty boulevard; malvern PA 19355
• MDR Report Key: 14711754
• MDR Text Key: 294130632
• Report Number: 14711754
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CT-SENSATION 64
• Device Lot Number: CE018943
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female