MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC IMRIS HC300 IOHV2 HEAD FLEX COIL; MAGNETIC RESONANCE IMAGING COILS

Model Number	HC300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Head Injury (1879)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The burn to the patient's forehead appeared to have been caused by the mr-conditional medtronic axiem stealth array device that was applied to the patient's forehead prior to and during intraoperative scanning.This was the hospital or staff's conclusion.A flex coil involved in the procedure was returned for evaluation.It was functionally tested/ inspected and found that the signal to noise ratio did not meet specification.It appeared that the coil had been dropped because there the pre-amps were found to be loose.It was concluded that, although the coil did not meet snr, it did not contribute to the burn on the patient's forehead.
Event or Problem Description
A neurological procedure with intraoperative scan took place on a (b)(6) month old pediatric patient.After the mri scan was completed and the patient was undraped, a full-thickness burn was noted to the patient's forehead.Per the hospital and their investigation, it was determined that the cause of the burn was a medtronic mr conditional axiem stealth array that was in place on the patient's forehead.There were two factors involved in the burn: first, there was a disconnect between the or and the mr technician that the device was in use and still on the patient's forehead prior to and during the scan; secondly, the instructions for use for the medtronic array was not followed for use within an mri, thus creating a full-thickness burn to the patient's forehead by the uncoiled wire that connects to the array.At the time of the scan, imris flex coils were being utilized however; there does not appear to be any relationship between the imris components and the patient burn.A hospital staff reported the incident to medtronic.

• Brand Name: IMRIS HC300 IOHV2 HEAD FLEX COIL
• Common Device Name: MAGNETIC RESONANCE IMAGING COILS
• Manufacturer (Section D): IMRIS - DEERFIELD IMAGING, INC; 5101 shady oak road; minnetonka MN 55343 4100
• Manufacturer (Section G): IMRIS - DEERFIELD IMAGING, INC; 5101 shady oak road; minnetonka MN 55343 4100
• Manufacturer Contact: kwaku amoah ; 5101 shady oak road; minnetonka, MN 55343-4100 ; 7632036344
• MDR Report Key: 13440837
• Report Number: 3010326005-2019-00028
• Device Sequence Number: 4304515
• Product Code: MOS
• UDI-Device Identifier: 00857534006226
• UDI-Public: 00857534006226
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K103506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace,Inspection
• Type of Report: Initial
• Report Date (Section B): 08/27/2019

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
• Operator of Device: Health Professional
• Device Model Number: HC300
• Device Catalogue Number: 110833-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 2 MO
• Patient Sex: Unknown