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

Device Problems Improper or Incorrect Procedure or Method (2017); Device-Device Incompatibility (2919)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

Oxygen tank pulled into mri scanner at (b)(6) hospital in (b)(6).Patient was in the scanner at the time and was struck on the feet.Patient was under anesthesia at the time.Event was never reported and a company other than the manufacturer was solicited to remove the tank.Event was covered up.Reference report: mw5118277.

• Brand Name: GE MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE HEALTHCARE MANUFACTURING LLC
• MDR Report Key: 17097508
• MDR Text Key: 316898494
• Report Number: MW5118276
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• 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: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male