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

Model Number 3032458

Device Problems Nonstandard Device (1420); Smoking (1585)

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

Event Date 06/14/2016

Event Type  malfunction  

Manufacturer Narrative

Bayer service performed a site visit and replaced the aioc (all-in-one computer) display and the system was restored to normal operation.Bayer radiology product analysis received and examined the returned aioc display.Visual examination found the hard drive power cable insulation was thermally degraded.Our investigation determined that a high current condition within the display module had occurred which caused material deformation and degradation of the surrounding plastic connectors and wiring insulation.On august 3, 2016, bayer medical care distributed a field safety notice recalling affected certegra® workstation all-in-one computers (aioc) with part number 3030896 that are used in conjunction with the medrad® stellant® ct injection system.

Event Description

The following information was received from a bayer representative: a customer reported smoke was seen coming from the medrad stellant ct injection system all-in-one computer (aioc) display.No injury or adverse event was reported.

• 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
• Manufacturer (Section G): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• Manufacturer Contact: lois miller ; 1 bayer drive; indianola, PA 15051 ; 7249407497
• MDR Report Key: 5893579
• MDR Text Key: 53671573
• Report Number: 2520313-2016-00058
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Radiologic Technologist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: 3032458
• Device Catalogue Number: SCT W/CERTEGRA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1