MAUDE Adverse Event Report: CANON MEDICAL SYSTEMS CORPORATION ULTIMAX; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number ULTIMAX

Device Problems Fire (1245); Smoking (1585); Noise, Audible (3273)

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

Event Date 05/17/2019

Event Type  Injury  

Event Description

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).

• Brand Name: ULTIMAX
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): CANON MEDICAL SYSTEMS CORPORATION
• MDR Report Key: 8640499
• MDR Text Key: 146074727
• Report Number: MW5086878
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ULTIMAX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other