MAUDE Adverse Event Report: CANON MEDICAL SYSTEMS CORPORATION CANON; MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Model Number MRT-1510/U4

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

Due to covid-19, the investigation at the site with all affected parties has been delayed and the manufacturer will submit a follow-up report upon completion of the investigation.

Event Description

Customer alleged that mri tech was performing a head scan and entered mri suite to inject patient for the last five minutes of the scan.Tech alleges that she did not notice anything out of the ordinary in mri suite at this time.After the scan had completed and while retrieving patient, the tech alleged that she smelled smoke and upon investigation, saw smoke near the bellows.Tech states that she promptly removed patient from mri suite to a safe distance.

Event Description

Customer alleged that mri tech was performing a head scan and entered mri suite to inject patient for the last five minutes of the scan.Tech alleges that she did not notice anything out of the ordinary in mri suite at this time.After the scan had completed and while retrieving patient, the tech alleged that she smelled smoke and upon investigation, saw smoke near the bellows.Tech states that she promptly removed patient from mri suite to a safe distance.

Manufacturer Narrative

The investigation confirmed that the terminal block was severely burned and that the bolts were loosened.In addition, it was discovered that the bolt in question had been removed during service and there was an issue with the service performed.The contact resistance increased over time, and heat generation and discharge caused the resin block of the terminal to melt and burn and fire spread to the cover plate.The cover plate was designed with a flame-retardant grade of v-0 but was installed with a lower flame-retardant grade equivalent to hb causing the fire to spread.The bolts on the terminal block in question are managed as important fastening parts, and normally a torque wrench is used.Over the course of the investigation we discovered that the proper torque wrench was not used at this site.Therefore, we instructed the service team to thoroughly carry out the work in (b)(6) 2021.Regarding the use of hb flame retardant materials in equipment, we decided to use flame retardant grade v-0 and changed the process to manage them as quality-critical parts.For existing sites, we replaced the plate with the correct flame-retardant material.During the replacement work, we confirmed that the bolts on the terminals were tightened, that there were no foreign objects caught in them and that the cables were properly secured.We explained the nature of the problem to customers using the equipment shipped by our company and completed the repair by changing the parts to specifications and inspecting the devices.

• Brand Name: CANON
• Type of Device: MAGNETIC RESONANCE DIAGNOSTIC DEVICE
• Manufacturer (Section D): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, tochigi 324-8 550; JA 324-8550
• Manufacturer (Section G): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, tochigi 324-8 550; JA 324-8550
• Manufacturer Contact: paul biggins ; 2441 michelle drive; tustin, CA 92780 ; 7146697808
• MDR Report Key: 10714503
• MDR Text Key: 212383126
• Report Number: 2020563-2020-00006
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MRT-1510/U4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 10/23/2023
• Supplement Dates FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1