MAUDE Adverse Event Report: SIEMENS AG/ SIEMENS HEALTHCARE GMBH MRI MAGNETOM ESPREE; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/08/2023

Event Type  Injury  

Event Description

(b)(6) hospital mri(magnetic resonance imaging) service provided by akumin service comes one day per week to provide mri service to prisoners throughout the (b)(6).Mri safety event occurred (b)(6) 2023 patient was brought onto mri trailer by corrections officer and screened for mri safety satisfactory by two technologists.Officer was told to remove restraints as they cannot go into scan room because of magnetic field.Patient was released from restraints and brought into scan room by one technologist as he was registered into system by second tech.As the tech was putting the anterior knee coil over the patient without incident the officer was standing at doorway observing as usual blocked by line of site to second scanning tech by exam room door.Suddenly i could see the officer running toward bore of magnet and i jumped up and ran into the room and positioned myself between the machine and the officer and ordered him to let go of the restraints stuck to the bore and get out of the room immediately to prevent further harm.After repeating my command several times i herded him out of the room and told him not to go back in as he could cause further harm.I instructed the other tech (b)(6) to remove the patient from the room and closed the door and notified radiology manager (b)(6) and doc control desk that there had been a serious incident and the pt and officer had suffered minor injuries.The pt who was positioned feet first into the magnet with the table in the raised position had not yet been sent into the machine and he felt his toes were hit by the restraints as they flew through the bore.He was wearing white leather nike sneakers at the time and described his injury as minor.The officer hurt his left arm holding onto the restraints and trying to pull them off the machine were and also described his injury as minor.The patient and officer were evaluated by radiology nurse (b)(6), and taken to acc(after care clinic) clinic to be evaluated.Officers generally leave restraints under patient chair at far end of trailer zone 3 and stand at the door and observe.I do not know why he chose to enter the room or cross the threshold with restraints in hand as there was no problem with the patient or any reason to enter.He was already instructed restraints come off they cannot enter the room.I believe he lost control of leg restraints that flew threw bore of magnet possibly hitting patients toe.He then ran toward machine and lost control of arm and body restraints which stuck to the exterior of the bore where he was wrestling them when i stepped in and told him to let go and get out of the room.The leg restraints were stuck on top of the far side of the bore.Siemens was called and all patients had to be cancelled for the day and the following day when they will ramp down the magnet to remove shackles.This facility has a poor understanding of mri safety and a severe lack of mri training for non mri personnel.Other safety reports have been filed and the best team, radiologists, and risk prevention have met with me before outlining that a continued lack of training in mri safety would result in a sentinel event at this institution.Calls for improved mri safety have gone unanswered at this facility.Pt was there for this test when accident occurred.

• Brand Name: MRI MAGNETOM ESPREE
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS AG/ SIEMENS HEALTHCARE GMBH
• MDR Report Key: 18131638
• MDR Text Key: 328160942
• Report Number: MW5148091
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White