MAUDE Adverse Event Report: MRI SCAN MACHINE; SYSTEM, NUCLEAR MAGNETIC, RESONANCE IMAGING

Device Problem Mechanical Problem (1384)

Patient Problems Erythema (1840); Swelling (2091)

Event Date 07/02/2019

Event Type  Injury  

Event Description

I was having a brain mri and noticed my ears got very warm and then hot.This happened before i was injected with any contrast material.I mentioned this to the tech who told me i was fine.I reported this incident to the radiologist and the office manager.My ears became red and swollen.I have pictures that were taken right after the scan.Of note: this mri machine was down due to mechanical problems 2 weeks prior on (b)(6) 2019.I did speak briefly with the (b)(6), md, facr, president and ceo who was kind but i have no idea what steps he is taking to avoid having another episode like this with another pt.Ears burned during brain mri at (b)(6).Fda safety report id # (b)(4).

• Brand Name: MRI SCAN MACHINE
• Type of Device: SYSTEM, NUCLEAR MAGNETIC, RESONANCE IMAGING
• MDR Report Key: 8772865
• MDR Text Key: 150681800
• Report Number: MW5087972
• 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: Patient
• Type of Report: Initial
• Report Date: 07/04/2019

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?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 73