MAUDE Adverse Event Report: CANON MEDICAL SYSTEMS CORPORATION CANON; MAGNETIC RESONANCE IMAGING SYSTEM

Model Number MRT-1510

Device Problem Use of Device Problem (1670)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/30/2019

Event Type  Injury  

Manufacturer Narrative

The investigation attributed the cause of this accident to user error, in that the safety manual instructions and the posted magnet safety signage were not observed and followed.The magnetic field near the magnet is strong enough to attract metal objects with great force, potentially causing serious injury or death.This is a well-recognized risk among mri system users.Furthermore, warning signs depicting the risk of magnetization of objects were posted appropriately at the mr facility when the incident occured.The technician sustained injuries to his hands and right rib.No additional injuries were reported, and he was able to continue working the next work day, (b)(6) 2019.No corrective action is necessary for this case because the accident resulted from a secondary user error.The user should not have tried to remove the floor polisher from the magnet after it was initially magnetized.The product safety manual states, "do not attempt to remove a ferromagnetic object attracted by the magnet if the magnet is still in the energized state.Even if the object can be removed, it may be pulled to the magnet again or move in an unexpected manner, resulting in a further accident." as a preventative action, the manufacturer will give an mr safety video to the affected facility for use during staff training, and will ask the facility to manage the mri room door-lock for untrained personnel, such as cleaning workers.

Event Description

Customer alleged that a cleaning contractor worker brought a ferromagnetric floor polisher into the mri room after the worker contacted the hospital technician.Customer reported that when the worker attempted to begin cleaning the mri room, the ferromagnetic floor polisher was attracted to the front of the magnet.The worker then reported this to the hospital technician.The technician then attempted to pull off the floor polisher from the magnet.Customer alleged that while attempting to remove the floor polisher from the magnet, the technician became stuck between the magnet and the floor polisher.The technician was allegedly able to escape from between the magnet and the floor polisher, but he injured his left hand: ring ringer, right hand: middle finger, ring finger, pinky finger laceration, and right rib (no.9 fracture).

• Brand Name: CANON
• Type of Device: MAGNETIC RESONANCE IMAGING SYSTEM
• Manufacturer (Section D): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, tochigi 324-8 550; JA 324-8550
• Manufacturer (Section G): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, tochigi 324-8 550; JA 324-8550
• Manufacturer Contact: paul biggins ; 2441 michelle drive; tustin, CA 92780 ; 7147305000
• MDR Report Key: 9501018
• MDR Text Key: 178314990
• Report Number: 2020563-2019-00011
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial
• Report Date: 12/19/2019

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?: No
• Device Operator: No Information
• Device Model Number: MRT-1510
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other