MAUDE Adverse Event Report: CANON MEDICAL SYSTEMS CORPORATION CANON; MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Model Number MRT-1550/VO

Device Problem Device Handling Problem (3265)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/15/2022

Event Type  Injury  

Event Description

It was reported that while two technologists moved a dockable table into the imaging room, before connecting the dockable table to the gantry, a wheel came over the foot of a female radiology technologist who was assisting on the far-right side facing the gantry and fractured her toe.

Manufacturer Narrative

An investigation determined that there was no malfunction of the device.The reported issue was determined to be user error.The device has a nameplate warning against caster foot pinching, which is explained in the operation manual and the safety manual.The cause was judged to be insufficient attention by the user when moving the dockable table.

• Brand Name: CANON
• Type of Device: MAGNETIC RESONANCE DIAGNOSTIC DEVICE
• 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 ; 7146697808
• MDR Report Key: 15771374
• MDR Text Key: 303425216
• Report Number: 2020563-2022-00007
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MRT-1550/VO
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other