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

Device Problem Unintended Movement (3026)

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

Event Date 01/28/2021

Event Type  Injury  

Event Description

Mri event- glidescope brought into zone 4.No injuries.Ge able to remove glidescope no problem.No damage to equipment.During an intubation in zone 4, a cna brought in a glidescope, and it was sucked into the magnet.No injuries, and we were able to pull the item out of the magnet.There were no issues with the magnet or image quality once qc was performed after the incident.Mri supervisor out on vacation, so that's why delayed notification.

• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE HEALTHCARE MANUFACTURING LLC
• MDR Report Key: 11313541
• MDR Text Key: 231983009
• Report Number: MW5099346
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): Y
• 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: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1