IMRIS HC300 IOHV2 HEAD FLEX COIL
Received Mar 12, 2019 · Event occurred Feb 13, 2019
Report 3010326005-2019-00003 · MDR key 8414797
Device
Generic name
Head Imaging Coil
Manufacturer
Deerfield Imaging, Inc.Model number
HC300 IOHV2Catalog number
110840-000
Lot number
N/A
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
25 YR
- Burn, Thermal
- Burn, Thermal
Narrative
Additional 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.
Description of Event or Problem
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.
Remedial action
- Replace
- Inspection