MAUDE Adverse Event Report: BAYER MEDICAL CARE, INC. MEDRAD MR INJECTOR; SOLARIS INJECTOR

Model Number 58746812

Device Problem Smoking (1585)

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

Event Date 09/21/2017

Event Type  malfunction  

Manufacturer Narrative

A bayer service representative visited the site and replaced the battery and several components.Product analysis received and examined the returned components.The solaris ep battery, electronics housing, head sensor printed circuit board (pcb), stand base interface pcb, and drive train assembly were found to be in normal condition with no abnormalities observed.Visual examination of the power drive pcb confirmed that several of the components were thermally degraded.Product analysis determined that the visualized smoke occurred as a result of an electronic fault of the power drive card which led to thermal degradation of its components and the adjacent servo/cpu card.

Event Description

The customer had reported seeing smoke coming out of the medrad® solaris ep injector base.The injector was powered down, unplugged from the wall, and removed from the mr suite.No injury or adverse event was reported.

• Brand Name: MEDRAD MR INJECTOR
• Type of Device: SOLARIS INJECTOR
• 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: diane eckert ; 1 bayer drive; indianola, PA 15051 ; 7249408677
• MDR Report Key: 6945827
• MDR Text Key: 90324118
• Report Number: 2520313-2017-00066
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: 58746812
• Device Catalogue Number: SOLARIS EP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2012
• 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