Summary of MedSun Reports Describing Adverse Events With Magnetic Resonance Imaging Machine (MRI)
MedSun: Newsletter #43, December 2009

An MRI machine is a vital diagnostic tool used by clinicians, but it presents some unique safety issues. Patients have been injured when ferromagnetic metal objects have become airborne when drawn toward the magnet's bore and other medical devices have been affected by the MRI's strong magnetic field. Also, some patients have received burns under certain circumstances, caused by the highly intense RF field. These are generally well known risks, largely preventable by vigilant screening of patients, proactive training of users, as well as implementation and observance of safety practices and signage. Nevertheless, FDA continues to receive reports of these occurrences.

Over the past 2 years, MedSun has received 14 adverse event reports associated with the magnetic resonance imaging device manufactured by 5 different firms. These reports were submitted by 10 hospitals between July 2007 and July 2009. The reported device problems were:
• Patient burns (8)
• MRI magnet pulled object across the room (4)
• Patient hearing affected (2)

No reports involved a patient death. The patient injuries listed below were reported in 12 of these 14 reports.
• Patient received burns/swelling (8)
• Patient or Nurse injured by flying metal object drawn in by MRI magnet (2)
• Patient received hearing damage or experienced tinnitus (2)

Of the reports that listed patient age, 1 had a patient age listed as less than 21 years and 10 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 7 reports involved female patients and a total of 5 reports involved male patients. These MedSun reports contributed to FDA awareness of the device problems.

Adverse Event Table
ManufacturerDevice Device Identifiers Event Description
GE Medical Systems, LLC MRI machine Device model #:1.5T;MR1-734647MR The patient called to complain that she was burned from an MRI 4 days earlier. She had her MRI and called four days later to say she had a red burn on both her shoulders after having her MRI, but didn't let anyone know about it. She said the redness is gone, but there is some swelling on one shoulder. I asked her to contact her PCP and let them know about it. The Tech who scanned this patient didn't know there was anything wrong, because the patient never said anything to her.
Philips Medical Systems MRI machine Unknown IV nurse entered MRI suite and brought her metal IV cart halfway in doorway of MRI suite. The force of the MRI magnet caused the IV cart to lift up and it flew through the air, on to the MRI machine. Patient was lying outside of the MRI, on the MRI table at the time. The cart did not hit him. Another Nurse was on right side of patient and was looking for venous access in his right arm at the time of the incident. She was not injured. No injury for any individual - lots of potential for injury! The IV nurse had been called to access the patient located in MRI. She did not realize the power of the MRI magnet especially when the patient was not in the MRI. She intended to leave the cart at the door, but should not have entered the room. This is being reported not because of a device malfunction but as an alert of an incident regarding an MRI and need for better vigilance and perhaps education regarding the fact that MRI magnets are ALWAYS on and the need for better safety.
Siemens Medical Solutions USA, Inc. MRI machine Unknown Patient had MRI of knee. Used ear protection with no music. Scan went as normal with no indication of problem. Days later the patient contacted hospital and reported hearing damage received during scan. Scan went as normal and no abnormal sounds detected. Patient did not indicate by voice or by facial expressions any discomfort during scan.
Siemans Medical Solutions USA, Inc MRI machine Device model #:7391167; Device catalog #:7391167 Patient from ED room one with MRI wheelchair said she would prefer to go on stretcher. After taking patient to the department, I took out MRI stretcher. Before moving patient to MRI stretcher I had to do MRI screening. Patient was complaining of her pain and said lets get the scan done. I was standing at the head of the stretcher and started to pull it in the room, not remembering patient had not been transferred. By the time I notice the pull on the stretcher it was too late. I was between the stretcher and the magnet. I used my body to reduce the impact. The patient was removed to the MRI stretcher and sent back to the ER.
IGC-Medical Advances, Inc. MRI machine Device model #:415GE - 64A Patient was screened for metal before procedure. No metal found and patient cleared for MRI. Shoulder coil placed on patient and put into magnet. During scan patient felt a shock in his abdomen and burning on shoulder. No metal found anywhere on patient
Philips Medical Systems MRI machine Device model #:ACS Intera Technicians were moving the IV pole and approached the 5 gauss line inside the MRI room. At that time, the IV pole was caught in the magnetic field and started moving toward the MRI machine. Technologist was struck on the arm by the pole as it moved towards the MRI machine.
Invivo Research, Inc. MRI machine Device model #:3155MVS; Took monitored patient out of MRI tube to insert dye. Noticed limb was cyanotic. Removed blanket from patient, and noted that patient was asystole and cyanotic to shoulders. The Invivo monitor showed a heart rate of 146 and pulse oximetry of 93. Invivo monitor continued to show HR of 146 at same time as another monitor showed asystole
GE Medical Systems, LLC MRI machine Device model #:2395001-2 This patient reported while having an MRI procedure, the noise that was transmitted was higher than on previous scans. During the scan, he reports he experienced tinnitus and that the tinnitus has persisted subsequently a month later.
GE Medical Systems, LLC MRI machine Device model #:2226300 Patient had an MRI on his left leg. The body coil was used for this procedure. The patient was properly oriented and padded to avoid contact with the magnet bore wall. When the patient arrived home he noticed two red raised areas (one on his left heel and one on his right wrist). He called the next day to report it to MRI and during the call he noticed the red areas had almost disappeared.
Philips Medical Systems MRI machine Unknown The Intravenous (IV) Team was called to start an IV on a patient who was to undergo a MRI. The IV nurse arrived in the MRI patient holding area with supply items on a wheeled metal cart. The MRI technician questioned the IV nurse regarding possession of any metal inside and outside of his/her body. The nurse removed all metal items and parked the metal supply cart in the patient holding area. Both a MRI supervisor and the technician cleared the nurse (by questioning and checking for any metal objects) before he/she entered the MRI scanning room. The technician and nurse assessed the patient; determined hot towels were needed to place on the patient's arms and left the scanning room to obtain necessary supplies. The nurse went to his/her metal supply cart left in the patient holding area to obtain supplies. As the technician turned to gather the towels, the technician heard a loud bang and crashing sound and observed that the nurse was no longer in the patient holding area. The technician ran into the scanning room and saw that the nurse had brought the metal supply cart into the scanning room and the cart was stuck to the side of the MRI magnet. The technician immediately took action and removed the patient from the scanning room. The patient was not harmed, nor was the nurse. Service was called immediately and the metal supply cart and other metal items were removed from the MRI magnet. A root cause analysis will be conducted.
Siemens Medical Solutions USA, Inc. MRI machine Device model #:7104719 Patient having an MRI prior to radiation therapy treatment. Patient was asked to lie on a carbon fiber and styrofoam positional immobilization board, which is MRI safe. After the scan was completed, the patient reported a burning sensation around their shoulder area. There were three areas of concern: one small black area anterior to two blisters located just posterior to the clavicle.
GE Medical Systems, LLC MRI machine Device model #:1.5T Patient was having a bilateral knee MRI. Because she was so large the pads were not used to protect the patient. The patient's thighs (both)received second degree burns from the MRI because they were touching the MRI bore of the magnet. Silvadene cream applied after incident. Referred to burn center.
Philips Medical Systems MRI machine Device model #:43000-588 Patient reported that he was burned by a "hot" wire under his wrist during an MRI scan. The radiology tech took the patient out of the tube to assess him and did not see evidence of any burn. The patient was re-wrapped with the sheet and placed back into the cylinder. The patient reported again feeling burned, and at the completion of the study, reported his complaint to the nurse on his unit. An area of redness 5 cm by 2cm was noted on his right wrist, and this resolved with lotion. Phillips staff were notified to check the machine. Of note, the patient body habitus was upper limit for MRI accessibility which may have contributed to the proximity of the coil.
GE Medical Systems, LLC MRI machine Device model #:MR1-734647MR Incident occurred on a 300 lb patient. Halfway thru the exam she pressed the emergency button stating that her arms were hot and hurt. I pulled her out and looked at them. They were hot to the touch. Within a minute, the patient stated that the sensation turned to a prickling feeling. Shortly after that the "painful" sensation was gone and it became dull. Once out of the exam room I personally examined her again before she left the building. Much of the redness had gone down. The patient had dark skin so it was difficult to tell the severity of the injury. I am solely going on her physical complaints.



Recall Table
Recall NumberManufacturer Device Recall Number Reason for Recall
Z-1824-2008 Resonance Technology Inc M.R. Vision 2000 Ultra Audio System Headset 2 Potential safety concerns - Use of this product with a MRI may result in the headset's cord overheating and patients experiencing burns to the skin.
Z-1042-2008 Siemens Medical Solutions USA Inc Magnetom Harmony 2 Magnet Quench unintended- magnet of a mobile MRI system quenched into the exam room.





MedSun Newsletters are available at www.fda.gov/cdrh/medsun