OtherMOS
MRI DEVICES CORP
Received Sep 5, 2000 · Event occurred Aug 24, 2000
Report MW1019834 · MDR key 294206
Device
Generic name
Small Extremity Mri Coil
Manufacturer
Mri Devices Corp.Model number
EXSCatalog number
EXS-635 YM
Lot number
JULY/2000
Product problems
- Heat
- Overheating of Device
- Replace
Patient
61 YR
- Erythema
Narrative
Description of Event or Problem
DURING MRI OF LEFT UPPER ARM PT COMPLAINED OF A VERY WARM FEELING AT THE SITE OF EXAMINATION. RPTR WENT INTO THE SCAN ROOM AND BROUGHT THE PT OUT OF THE MAGNET AND NOTICED THAT THE COIL WAS VERY WARM, EVEN HOT AT ONE PART. REMOVED THE COIL AND REPLACED IT WITH ANOTHER COIL AND FINISHED THE EXAM. SOME REDNESS WAS NOTED DURING COIL CHANGE. WHEN EXAM WAS OVER RPTR CHECKED PT AND NO REDNESS WAS THERE AND PT STATED THEY WERE ALRIGHT. PT LEFT THE IMAGING CENTER WITH NO PROBLEMS.