MAUDE Adverse Event Report: CANON MEDICAL SYSTEMS CORPORATION CANON; MRI SYSTEM

Model Number MRT-2020/J1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 01/06/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturer conducted an investigation into the cause of this incident and determined that the mri system and the coil (16ch flex speeder medium) used functioned as designed and no defects were found.The system is not considered the cause of the patient burn.The patient had second and third degree burns on both of his calves.At the initial set up of the exam, the patient's calves were not in contact with each other, but when the patient moved during the exam, there was a possibility that his calves touched.This contact would cause the formation of a high frequency current loop of both legs.If a high frequency current flows in the loop,the skin at the point of contact or near-contact heats up, resulting in a burn.The manufacturer will notify the customer that foam pads or there appropriate material should be used to prevent skin to skin touching, therefore eliminating the possibility of the forming of a high frequency current loop.Customer will also be instructed to inform the patient to press the call button during the exam iif he feels any heat or pain and the exam will be stopped.This incident occurred in (b)(6).

Event Description

A patient had an mri examination near his left knee which used a 16ch flex speeder medium coil following th exam, the patient returned home and noticed that there were blisters on his calves.He was diagnosed with a low temperature burn by his doctor.

• Brand Name: CANON
• Type of Device: MRI SYSTEM
• Manufacturer (Section D): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, 324-8 550; JA 324-8550
• Manufacturer (Section G): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, 324-8 550; JA 324-8550
• Manufacturer Contact: paul biggins ; 2441 michelle drive; tustin, CA 92780 ; 7147305000
• MDR Report Key: 8753666
• MDR Text Key: 149807303
• Report Number: 2020563-2019-00004
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MRT-2020/J1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/09/2018
• Initial Date FDA Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other