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

Model Number 60726807

Device Problems Smoking (1585); Defective Device (2588); Electrical Overstress (2924); Environmental Particulates (2930)

Patient Problem No Patient Involvement (2645)

Event Date 06/27/2018

Event Type  malfunction  

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 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.

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
• Type of Device: CT INJECTION SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 7710244
• MDR Text Key: 114701346
• Report Number: 2520313-2018-00049
• Device Sequence Number: 1
• Product Code: DXT
• UDI-Device Identifier: 00616258008943
• UDI-Public: (01)00616258008943
• Combination Product (y/n): N
• PMA/PMN Number: K082905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1