MAUDE Adverse Event Report: SIEMENS HEALTHCARE SYSTEM SOMATOM DEFINITION AS; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 08098027

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/21/2017

Event Type  malfunction  

Event Description

During computed tomography angiography the system stopped scanning.The scanner was operational after reboot but it was decided not to use the system for cta studies.

• Brand Name: SYSTEM SOMATOM DEFINITION AS
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE; 40 liberty boulevard; mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 7247089
• MDR Text Key: 99201473
• Report Number: 7247089
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 08098027
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2018
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES.