inforMED
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

EXS

Catalog 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.