FDA.reportPublic FDA data

MAUDE MDR 9587117

MDR report key
9587117
Report number
2020563-2020-00001
Event key
0
Event type
3
Date of event
2019-12-19
Date received
2020-01-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
PAUL BIGGINS
Address
2441 MICHELLE DRIVE TUSTIN CA 92780 US
Phone
714-714-7147
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CANONMAGNETIC RESONANCE IMAGING SYSTEMCANON MEDICAL SYSTEMS CORPORATIONLNHMRT-1503/P3Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-1401. O

Event Narratives#

N

Patient 1

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.

D

Patient 1

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.