SENSE 7CH 1.5T BREAST COIL
Received Jul 9, 2012 · Event occurred Jun 5, 2012
Report 1056069-2012-00005 · MDR key 2651116
Device
Manufacturer
InvivoModel number
4522-150-40213Product problems
- Improper or Incorrect Procedure or Method
Patient
56 YR
- Bone Fracture(s)
Narrative
Description of Event or Problem
THE PT WAS PLANNED FOR AN MRI EXAMINATION. SHE WAS PLACED IN PRONE POSITION WITH AN IN VIVO 7CH BREAST COIL UNDERNEATH HER CHEST. WHEN THE TECHNOLOGIST MOVED THE PT INTO THE MR SCANNER (PHILIPS ACHIEVA 1.5T NOVA SYSTEM), THE PT WAS SQUEEZED BETWEEN THE TOP OF THE MAGNET BORE AND THE BREAST COIL. THE PT PANICKED AND STARTED TO MOVE IN AN ATTEMPT TO EXIT THE BORE OF THE MR SCANNER. THE PT WAS DIAGNOSED WITH A RIB FRACTURE.
Additional Manufacturer Narrative
(B)(4). 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.¿