MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC. GE EXCITE HDX; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2022

Event Type  Injury  

Event Description

Patient was taken into the mri with metal waistband from the correctional facility on and the patient got stuck to the mri machine.The officer that was with the patient/inmate was not cleared but entered the room to help and was pulled to the mri machine and stuck to the mri machine as well.The mri machine had to be turned off (quenched) to relieve both the patient and the officer from the mri machine.

• Brand Name: GE EXCITE HDX
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC.
• MDR Report Key: 16610600
• MDR Text Key: 312022933
• Report Number: MW5115950
• 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: Unknown
• Type of Report: Initial
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Female