CANON MRT-1503/P3

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-14 for CANON MRT-1503/P3 manufactured by Canon Medical Systems Corporation.

Event Text Entries

[174910114] 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.
Patient Sequence No: 1, Text Type: N, H10


[174910115] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020563-2020-00001
MDR Report Key9587117
Report SourceUSER FACILITY
Date Received2020-01-14
Date of Report2020-01-14
Date of Event2019-12-19
Report Date2020-01-06
Date Reported to Mfgr2020-01-06
Date Mfgr Received2020-01-06
Device Manufacturer Date2003-08-01
Date Added to Maude2020-01-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPAUL BIGGINS
Manufacturer Street2441 MICHELLE DRIVE
Manufacturer CityTUSTIN CA 92780
Manufacturer CountryUS
Manufacturer Postal92780
Manufacturer Phone7147305000
Manufacturer G1CANON MEDICAL SYSTEMS CORPORATION
Manufacturer Street1385 SHIMOISHIGAMI
Manufacturer CityOTAWARA-SHI, 324-8550
Manufacturer CountryJA
Manufacturer Postal Code324-8550
Single Use3
Remedial ActionNO
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCANON
Generic NameMAGNETIC RESONANCE IMAGING SYSTEM
Product CodeLNH
Date Received2020-01-14
Model NumberMRT-1503/P3
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCANON MEDICAL SYSTEMS CORPORATION
Manufacturer Address1385 SHIMOISHIGAMI OTAWARA-SHI, 324-8550 JA 324-8550


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-14

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