MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION OASIS MRI SYSTEM; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 01/05/2022

Event Type  malfunction  

Manufacturer Narrative

This incident was determined to be caused by the user's lack of attention in bringing a metal wheelchair into an active mr room.Fujifilm has recommended the user to be retrained on safety warnings described in the device labeling.

Event Description

On 10 january 2022, fujifilm healthcare corporation was informed of an incident related to oasis mri system.Event description is as follows: technician was trying to take a patient out of the room with a ferrous wheelchair.As the technician backed the wheel chair into the room, wheelchair was pulled in by the magnet.She had the breath knocked out of her and was pinned by her hand but was able to get free.The technician had to go to urgent care for minor injuries.She had a sprained thumb, bruised shoulder, and twisted her knee.Patient was not in the path of the chair, therefore there were no injuries to the patient.There is no patient injury or death associated with event.

• Brand Name: OASIS MRI SYSTEM
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi; chiba-ken 277-0 704; JA 277-0704
• Manufacturer (Section G): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 704; JA 277-0704
• Manufacturer Contact: yasuo okamoto ; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0-704 ; JA 277-0704
• MDR Report Key: 13423231
• MDR Text Key: 287253958
• Report Number: 3018423337-2022-00001
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 04580292768186
• UDI-Public: (01)04580292768186(11)181215(250)G210131918
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Female