MAUDE Adverse Event Report: CANON MEDICAL SYSTEMS CORPORATION CANON MAGNETIC RESONANCE IMAGING SYSTEM

Model Number MRT-1503/P3

Device Problems Fire (1245); Smoking (1585); Misassembly During Maintenance/Repair (4054)

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

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

The investigation attributed the cause of this accident to the use of an incompatible and unapproved component with the canon mr system. It appears that a previous service provider of the site cut the power cable to the cold head compressor and added a plastic connector. It is judged that the connector failed, which allegedly caused the incident. The site is currently between third party service providers, and therefore notified canon directly of the incident. Canon engineer went on-site to replace the cable and test the system. He reported that everything appeared to be functioning as intended after the cable replacement. The customer then communicated to canon that this modification has been done at their other sites as well. Canon engineer reached out to the customer's current service provider, entech banner. Canon engineer stated that he visited two other customer sites and found that both canon systems had the unauthorized hubble connector in the compressor power line. From the engineer's examination, he noted that at least one other site had dark "age" spots in the white plastic of the connector. Canon recommended to entech banner to replace the current cable configuration as soon as possible with factory-approved parts as a safety precaution. Entech banner noted that these modifications were likely installed some time ago, and have agreed to schedule the replacement of these unauthorized parts. It is reported that two site employees were examined by a doctor after breathing in black smoke from the incident, and that both employees were cleared for work the next day.

Event Description

Customer called canon customer engineer to report a fire in the equipment room involving a hubbell connector in the refrigerator compressor power line. Black smoke and flames were reported. The customer entered the equipment room and quickly flipped off several pcdu breakers as well as a main wall panel breaker to remove power from the system, which put out the flames. When the canon customer engineer arrived on-site, he discovered that a hubbell connector that had been inserted in the power line to the compressor was melted and burned. Upon inspection, burn marks were present on the wall and floor panel near where the hubbell connector was sitting. The hubbell connector was not a manufacturer-authorized modification. Canon customer engineer replaced the entire cable from the pcdu to the compressor with a manufacturer-approved replacement. Two site employees were sent to a doctor, as they had allegedly breathed in black smoke from the incident.

• Brand Name: CANON
• Type of Device: MAGNETIC RESONANCE IMAGING 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: 9587117
• Report Number: 2020563-2020-00001
• 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: Notification
• Type of Report: Initial
• Report Date: 01/06/2020,01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: MRT-1503/P3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 01/06/2020
• Date Manufacturer Received: 01/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

• Patient Outcome(s): Other