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

Model Number 3007301

Device Problems Fire (1245); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2014

Event Type  Other  

Event Description

The site reported the following: a ct technologist observed smoke and a small flame at the connection between one of the heat maintainers and the stellant ct injector head.The subject heat maintainer that disengaged from the system and fell to the floor.There was no injury or adverse event reported as a result.

Manufacturer Narrative

Bayer service performed a service checkout of the stellant injector (b)(4) and determined that the injector system's 48 volt supply was operating correctly.Bayer r& i quality assurance product analysis received and examined the subject heat maintainer and associated parts.Visual examination found thermal damage present on the heat maintainer connectors and power wires.The cause of the reported problem was a short circuit within the heat maintainer connector from movement and wear of the cable behind the connector.The short circuit led to localized heating of the connector assembly, ultimately resulting in the reported occurrence.

• Brand Name: STELLANT DUAL CT INJECTOR
• Type of Device: CT INJECTION SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; indianola PA
• Manufacturer Contact: susan sherwin ; 1 bayer drive; indianola, PA 15051 ; 7249408678
• MDR Report Key: 3688094
• MDR Text Key: 4242679
• Report Number: 2520313-2014-00012
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3007301
• Device Catalogue Number: SCT D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2009
• 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