InjuryMOS
SENSE 7CH 1.5Y BREAST COIL
Received Jul 9, 2012 · Event occurred Jun 21, 2010
Report 1056069-2012-00004 · MDR key 2651115
Device
Manufacturer
InvivoModel number
4522-150-40213Product problems
- Device Operates Differently Than Expected
Patient
62 YR
- Bone Fracture(s)
Narrative
Description of Event or Problem
THE PT WAS PLACED ON THE SENSE BODY COIL AND BREAST PAD AND SLOWLY MOVED INTO THE MACHINE IN A PRONE POSITION. THE PT WAS ADVISED TO ALERT THE OPERATORS IF SHE WAS IN ANY DISCOMFORT. ONCE THE PT WAS IN POSITION, SHE JOLTED AND TOLD THE TECHS TO GET HER OUT. AFTERWARDS 9 RIB FRACTURES (4 ON RIGHT 5TH, 6TH, 7TH AND 8TH AND 5 ON LEFT 4TH, 5TH, 6TH 7TH AND 8TH) WERE OBSERVED.
Additional Manufacturer Narrative
(B)(4). RESULTS: UNUSUAL EVENT. CONCLUSIONS: THE INJURY WAS ATTRIBUTED TO MOVEMENT OF THE PT WHILE INSIDE THE BORE OF THE MAGNET SYSTEM.