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

Model Number 08098027

Device Problem Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 08/02/2021

Event Type  malfunction  

Event Description

Patient was having ct scan and gantry kept shutting down.Had to abort study.Images are on machine but unable to reconstruct.Service was called for repair.Will only call patient back for repeat if the images can not be retrieved by engineer.Currently waiting for engineer to arrive.

• Brand Name: SYSTEM SOMATOM DEFINITION AS
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 40 liberty boulevard; mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 12539883
• MDR Text Key: 273592970
• Report Number: 12539883
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2021
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 09/28/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1