SENSE 7CH 1.5T BREAST COIL

Description of Event or Problem

THE PT WAS PREPARED FOR A MAGNETIC RESONANCE (MR) IMAGING BREAST EXAMINATION USING AN IN VIVO 7-CHANNEL BREAST COIL ACCESSORY DEVICE. WHEN THE OPERATOR MOVED THE PT INTO THE MR SCANNER (PHILIPS ACHIEVA 1.5T MODEL), THE PT SCREAMED. THE HEALTH CARE FACILITY REPORTED THAT THE PT SUSTAINED A BROKEN RIB.

Additional Manufacturer Narrative

(B)(4). METHOD/RESULTS: OPERATIONAL CONTEXT CAUSED EVENT. CONCLUSIONS: USER ERROR CAUSED EVENT. THE INJURY WAS ATTRIBUTED TO OPERATOR ERROR DURING MOVEMENT OF THE PT INTO THE BORE OF THE MAGNET SYSTEM. THE INSTRUCTIONS FOR USE PROVIDED FOR THE IN VIVO BREAST COIL DEVICE CAUTIONS THE USER TO ¿ASSURE THAT THE PT IS NOT TOUCHING THE BORE¿.