MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-24 for ULTIMAX manufactured by Canon Medical Systems Corporation.
[146074727]
Toshiba / canon ultimax x-ray machine started on fire in the middle of the night. The equipment was powered off and not in use. The x-ray staff heard a popping noise 12:30 - 1 am and when they walked into the room, smoke was coming from the cabinet. They extinguished the fire and called in the fire dept to make sure the fire was out. The covers were removed from the cabinet by the fire dept to verify the fire was out. The oems service vendor came onsite on monday the 20th and removed the chiller and start repairing the machine. The chiller that started on fire has been moved by the biomed dept until everything is resolved and the chiller is no longer needed. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086878 |
| MDR Report Key | 8640499 |
| Date Received | 2019-05-24 |
| Date of Report | 2019-05-22 |
| Date of Event | 2019-05-17 |
| Date Added to Maude | 2019-05-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTIMAX |
| Generic Name | SYSTEM, X-RAY, ANGIOGRAPHIC |
| Product Code | IZI |
| Date Received | 2019-05-24 |
| Model Number | ULTIMAX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CANON MEDICAL SYSTEMS CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-24 |