SIGNA EXCITE 1.5T
Received Oct 20, 2006 · Event occurred Mar 16, 2006
Report 778448 · MDR key 778448
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
56 YR
- Blister(s)
- Bruise/Contusion
- Pain
- Tingling
- Rupture
Narrative
Description of Event or Problem
PATIENT HAD MRI BILATERAL BREAST EXAM PERFORMED. DURING THE PROCEDURE THE PATIENT EXPERIENCED TINGLING OF BOTH THUMBS, BUT NO WARMTH OR REDNESS WERE NOTED. AFTER DISCHARGE HOME, A BLISTER DEVELOPED ON THE LEFT THUMB. A PHYSICIAN CONFIRMED ONE THUMB HAD ECCHYMOSIS UNDER THE THUMBNAIL AND WAS PAINFUL TO THE PATIENT AND THE OTHER THUMB HAD A SURFACE ABNORMALITY WITH ESCHAR CONSISTENT WITH BLISTER AND RUPTURE. THERE WERE NO COILED WIRES/LEADS, ETC. ATTACHED TO PATIENT. NO HANDS AND/OR FINGERS WERE TOUCHING THE SCANNER WALLS. THE PATIENT REPORTS THEY DID NOT HAVE NAIL POLISH OR JEWELRY ON. THE PATIENT WAS RECEIVING INTRAVENOUS SOLUTION AND THE IV POLE WAS IN THE ROOM. THE PATIENT WAS PRONE POSITIONED WITH FEET FIRST WITH ARMS AND HANDS OUT FRONT WITH PALMS DOWN ON THE TABLE. A SIMILAR EVENT OCCURRED WITHIN THE SAME WEEK WITH ANOTHER PATIENT. (THIS PATIENT HAD AN IV ALSO BUT THERE IS NO OTHER INFORMATION AVAILABLE CONCERNING THE PATIENT.)BOTH PATIENTS WERE IMAGED IN THE 7 CHANNEL MRI DEVICES COIL UTILIZING VIBRANT SINGLE PHASE AND MULTI-PHASE PROTOCOLS. IN BOTH INSTANCES, THE PATIENT WAS POSITIONED FOR A BREAST MRI. THE IV POLE AND LACK OF PADDING MAY HAVE CONTRIBUTED TOWARD THE EVENT. THE IV POLE MAY HAVE REDIRECTED THE RF ENERGY. SINCE THIS EVENT, 1 CM THICK PADDING HAS BEEN ADDED TO THE MRI STRETCHER. MANUFACTURER PROVIDED IV POLES WILL BE REMOVED FROM MRI. AS AN ADDITIONAL PRECAUTION, A METAL DETECTOR WILL BE INSTALLED AT THE ENTRANCE TO THE MAGNET DOOR. WE HAVE NOT RECEIVED ANY OTHER INFORMATION PERTAINING TO THE BURNS FROM EITHER OF THE VENDORS.