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.
[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
| Report Number | 2020563-2020-00001 |
| MDR Report Key | 9587117 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-14 |
| Date of Event | 2019-12-19 |
| Report Date | 2020-01-06 |
| Date Reported to Mfgr | 2020-01-06 |
| Date Mfgr Received | 2020-01-06 |
| Device Manufacturer Date | 2003-08-01 |
| Date Added to Maude | 2020-01-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAUL BIGGINS |
| Manufacturer Street | 2441 MICHELLE DRIVE |
| Manufacturer City | TUSTIN CA 92780 |
| Manufacturer Country | US |
| Manufacturer Postal | 92780 |
| Manufacturer Phone | 7147305000 |
| Manufacturer G1 | CANON MEDICAL SYSTEMS CORPORATION |
| Manufacturer Street | 1385 SHIMOISHIGAMI |
| Manufacturer City | OTAWARA-SHI, 324-8550 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 324-8550 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CANON |
| Generic Name | MAGNETIC RESONANCE IMAGING SYSTEM |
| Product Code | LNH |
| Date Received | 2020-01-14 |
| Model Number | MRT-1503/P3 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CANON MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | 1385 SHIMOISHIGAMI OTAWARA-SHI, 324-8550 JA 324-8550 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-14 |