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

Model Number MRT-2020

Device Problem Inadequate or Insufficient Training (1643)

Patient Problem Burn(s) (1757)

Event Date 02/07/2019

Event Type  Injury  

Manufacturer Narrative

It has been determined by the manufacturer that the cause of the patient's burn is user error.The instructions to avoid a burn during a procedure are described in the safety and operation manuals.It was found that the gap between the patient's left hand and left thigh was inadequate.If skin surface of two different parts of the patient's body come into contact or almost come into contact, a conductive loop may form in the patient's body.When a high frequency magnetic field is generated during scanning, an electromotive force is induced causing a high frequency current to flow in the conductive loop.The skin at the point of contact or near-contact will heat, resulting in a burn.Please note that this issue occured at a hospital in (b)(6).

Event Description

Burn on left hand of patient.

• 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: 8919034
• MDR Text Key: 157487448
• Report Number: 2020563-2019-00007
• 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: company representative,user f
• Type of Report: Initial
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MRT-2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 38 YR