MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC SOMATOM DEFINITION AS; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 8098027

Device Problems Display or Visual Feedback Problem (1184); Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 01/11/2022

Event Type  malfunction  

Event Description

Patient was to have gated chest only tavi with venous chest delay.Non con and arterial images were completed and then the scanner flashed two errors quickly and would let the scanner load the delay phase chest.Had to hit "continue" on the scanner and then close out and reopen exam appending on chest to get it to load.Cardiac reading room called and approved to give 75 ml more contrast for the venous phase chest.Test completed and patient sent back to room.Clinical engineering called for scanner.

• Brand Name: SOMATOM DEFINITION AS
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC; 40 liberty boulevard; mailcode: 64-1a; malvern PA 19355
• MDR Report Key: 13415282
• MDR Text Key: 284808522
• Report Number: 13415282
• 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: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8098027
• Device Catalogue Number: 8098027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/21/2022
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Sex: Female