MAUDE Adverse Event Report: GE HEALTHCARE MANUFACTURING LLC MRI; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 1-5T-MR450W WGEM

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

Event Date 03/21/2024

Event Type  Injury  

Event Description

Patient on vent came to mri(magnetic resonance imaging) department on monitor.Patient unhooked from monitor.Patient taken into mri room, where monitor was inadvertently left on the mri table.Monitor flew into magnet.No injury to patient or staff.Monitor was able to be removed from the magnet.

• Brand Name: MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE HEALTHCARE MANUFACTURING LLC
• MDR Report Key: 18994115
• MDR Text Key: 338936261
• Report Number: MW5153322
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1-5T-MR450W WGEM
• Was Device Available for Evaluation?: Yes
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White