SENSE 7-CHANNEL BREAST COIL 1.5T
Received May 18, 2012 · Event occurred Nov 18, 2011
Report 1056069-2012-00001 · MDR key 2583187
Device
Product problems
- Improper or Incorrect Procedure or Method
Patient
Not reported
- Bone Fracture(s)
- Pain
- Physical Entrapment
Narrative
Additional Manufacturer Narrative
THE ADVERSE EVENT WAS DETERMINED TO BE USER ERROR. WHEN THE PT WAS PLACED IN THE MR SCANNER USING THE SENSE MR COIL THERE WAS AN OBVIOUS INTERFERENCE BETWEEN THE PT'S BACK AND THE MRI BORE. THE INSTRUCTIONS FOR USE PROVIDED WITH THE MR COIL DEVICE CAUTIONS THE USER TO "ASSURE THAT THE PT IS NOT TOUCHING THE BORE".
Description of Event or Problem
IN PREPARATION FOR AN MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE, A FEMALE PT WAS PLACED IN A PRONE POSITION WITH A SENSE BREAST COIL IN PLACE UNDERNEATH THE CHEST. THE PT COMPLAINED OF PAIN IN HER SIDE AT THE TIME. WHEN THE TECHNOLOGIST MOVED THE PT INTO THE BORE, THE PT WAS SQUEEZED BETWEEN THE TOP OF THE MR SCANNER BORE AND THE SENSE BREAST COIL ACCESSORY DEVICE. WHEN THE TECHNOLOGIST NOTICED THE SITUATION, THE PT WAS REMOVED FROM THE BORE. THE MR SCAN WAS NOT COMPLETED. AFTER LEAVING THE MRI FACILITY, THE PT REC'D X-RAYS THAT SHOWED BROKEN RIBS.