ACHIEVA 3T
Received Jan 16, 2010 · Event occurred Dec 18, 2009
Report 1594263 · MDR key 1594263
Device
Generic name
Mri, 3t
Manufacturer
Philips Medical SystemsModel number
RELEASE 2.6.3.4Catalog number
*
Lot number
*
Product problems
- Insufficient Device Problem Information
Patient
73 YR
- Erythema
- Burning Sensation
Narrative
Description of Event or Problem
PATIENT WAS GETTING AN MRI SCAN INVOLVING HER PELVIS WHEN PATIENT COMPLAINED OF A BURNING SENSATION ON HER LEFT SIDE. THE PATIENT SQUEEZED THE EMERGENCY BALL AND TWO TECHNOLOGISTS WENT IN TO INVESTIGATE. THE PATIENT HAD REDNESS TO THE SKIN AND THE APPARATUS USED IN THE PROCEDURE WAS QUITE WARM. ON SITE PERSONNEL FROM PHILIPS WAS CALLED AS WELL AS OUR ON PHYSICIST WAS NOTIFIED.THE COIL IN USE WHEN THE PATIENT COMPLAINED OF HEAT WAS THE 6 CHANNEL CARDIAC COIL FOR THE CLINICAL 3T SCANNER. THIS COIL WAS IMMEDIATELY REMOVED BY THE TECHS FOR THE COMPLETION OF THE SCAN. THE PHILIPS SERVICE ENGINEER AND I INSPECTED THE COIL. THERE WAS VISIBLE WEAR AT ONE OF RF BALUN COMPONENTS. THE SERVICE ENGINEER REMOVED THE PLASTIC COVERING OF THIS BALUN TO REVEAL THAT THE SOLDER AROUND GROUND SHIELD SLEEVE WAS MECHANICALLY BROKEN ESSENTIALLY AROUND THE ENTIRE CIRCUMFERENCE OF THE SLEEVE. I SPECULATE THE HIGH IMPEDANCE PATH TO GROUND AT THIS FAILURE POINT WAS THE SOURCE OF HEATING FELT BY THE PATIENT. THE COIL WAS REMOVED FROM SERVICE FOR REPAIR/REPLACEMENT BY PHILIPS.