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

Device Problem Electromagnetic Interference (1194)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2020

Event Type  Injury  

Event Description

Metal procedure table pulled into the bore of a 3t magnet.

• Brand Name: GE ARCHITECT
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE
• Manufacturer (Section D): GE HEALTHCARE MANUFACTURING LLC.
• MDR Report Key: 9829297
• MDR Text Key: 184057094
• Report Number: MW5093741
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other