MAUDE Adverse Event Report: BAYER MEDICAL CARE, INC. STELLANT DUAL CT INJECTOR; CT INJECTION SYSTEM

Model Number	60726807
Medical Device Problem Codes	Smoking (1585); Defective Device (2588); Electrical Overstress (2924); Environmental Particulates (2930)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the limited information, we are unable to determine the root cause of the alleged incident; however, the equipment is scheduled to return to pittsburgh for a full evaluation.Once the evaluation is completed, a follow-up report will be submitted.This information does not constitute an admission that the device, the company, or its employees caused or contributed to a reportable event.
Event or Problem Description
A bayer representative had reported seeing smoke coming out of the stellant ct injector base unit.The injector was powered down and unplugged from the wall.No injury or adverse event was reported.
Additional Manufacturer Narrative
Bayer service replaced the base unit and confirmed system functionality.Bayer product analysis received and examined the returned base unit.Visual examination confirmed that there were degraded components on the 15v power supply which are consistent with a typical electronic fault.The power supply is centrally located within a metal electronic chassis of the base unit of the stellant injector and is well isolated from the patient and user.Therefore, there is no injury or property damage risk if the fault were to recur.

• Brand Name: STELLANT DUAL CT INJECTOR
• Common Device Name: CT INJECTION SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 7710244
• Report Number: 2520313-2018-00049
• Device Sequence Number: 14098406
• Product Code: DXT
• UDI-Device Identifier: 00616258008943
• UDI-Public: (01)00616258008943
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K082905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2018

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
• Operator of Device: Health Professional
• Device Model Number: 60726807
• Device Catalogue Number: SCT W CERTEGRA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1