• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CANON MEDICAL SYSTEMS CORPORATION CANON; MAGNETIC RESONANCE DIAGNOSTIC DEVICE Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10714503
MDR Text Key212383126
Report Number2020563-2020-00006
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 NumberMRT-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 Received10/21/2020
Supplement Dates Manufacturer Received10/23/2023
Supplement Dates FDA Received11/17/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-