MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SOMATOM EMOTION 16 SLICE (DE); SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 10046789

Device Problem Computer Operating System Problem (2898)

Patient Problem No Information (3190)

Event Date 09/06/2017

Event Type  malfunction  

Event Description

Ct would not come back up after re-starting.System unable to boot up after several power re-settings called for service.System reporting a database problem and error logger reporting network problem.System cleanup and shutdown did not fix the problem.Systems database reset (all images deleted), system able to boot up.Completed checkup and okay on quality assurance.Navigator console shut itself off.After power restored all test of system performance and image quality was run multiples times without error.Ct replaced, device retired now.

• Brand Name: SOMATOM EMOTION 16 SLICE (DE)
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; robert phillips; 40 liberty boulevard mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 6943985
• MDR Text Key: 89130485
• Report Number: 6943985
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 10046789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1