MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION ECHELON XL 1.5T MRI SYSTEM; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 07/13/2023

Event Type  Injury  

Manufacturer Narrative

The ifus describe guidelines for proper patient placement during imaging scans and advise against placing the patient in direct contact with any part of the device.The technician placed the call bell cord over the patient's wrist.Therefore, the root cause is determined to be a usage error due to incorrect patient setting.Fujifilm is monitoring the facility for similar issues.

Event Description

On (b)(6) 2023, fujifilm healthcare corporation became aware of an event involving echelon xl 1.5t mri system.It was reported that the patient complained of being burnt on her left wrist by the call bell cord during a scan of the lumbar spine.The patient experienced temporary redness/warming of the affected area and was observed at the facility.There were no visible signs of blistering and the patient was released without need for medical treatment or surgical intervention.There was no death associated with the event.

• Brand Name: ECHELON XL 1.5T MRI SYSTEM
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• Manufacturer (Section G): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• Manufacturer Contact: yasuo okamoto ; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0-804 ; JA 277-0804
• MDR Report Key: 17501313
• MDR Text Key: 320877631
• Report Number: 3018423337-2023-00007
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2023
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Other
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 91 KG