MAUDE Adverse Event Report: DEERFIELD IMAGING, INC. IMRIS HC300 IOHV2 HEAD FLEX COIL; HEAD IMAGING COIL

Model Number HC300 IOHV2

Device Problem Insufficient Information (3190)

Patient Problem Burn, Thermal (2530)

Event Date 02/13/2019

Event Type  Injury  

Manufacturer Narrative

The head coil in question is in the root cause evaluation stage and investigation is on-going as to whether the patient burn was caused by the flex coil, or personnel not following instructions for use, or other reasons.A follow-up report shall be submitted once sufficient information is available to determine the seriousness of the patient burn and the root cause evaluation.

Event Description

A patient experienced a burn on his left forearm, approximately 5cm x 2 cm, during a procedure.The burn was not discovered until after the case and was reported to imris personnel as soon as it was determined that it most likely occurred from the mr scan during the procedure.The mri or director stated that she was not aware of any medical intervention required regarding the burn or how the hospital classified the burn.

• Brand Name: IMRIS HC300 IOHV2 HEAD FLEX COIL
• Type of Device: HEAD IMAGING COIL
• Manufacturer (Section D): 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: todd sperling ; 5101 shady oak road; minnetonka, MN 55343-4100 ; 7632036344
• MDR Report Key: 8414797
• MDR Text Key: 138641097
• Report Number: 3010326005-2019-00003
• Device Sequence Number: 1
• Product Code: MOS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HC300 IOHV2
• Device Catalogue Number: 110840-000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 127