MAUDE Adverse Event Report: GENERAL ELECTRIC CO. GE MRI MACHINE - ARTIST; SYSTM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number ARTIST 1.5 TESLA

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Itching Sensation (1943)

Event Date 01/08/2020

Event Type  Injury  

Event Description

This pt had an mri thoracic spine and afterwards she complained that her chest was itchy and red.No tests were required.The radiologist evaluated the pt and told her to take some oral benadryl for the itching.Fda safety report id# (b)(4).

• Brand Name: GE MRI MACHINE - ARTIST
• Type of Device: SYSTM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GENERAL ELECTRIC CO.
• MDR Report Key: 9580791
• MDR Text Key: 175053988
• Report Number: MW5092159
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ARTIST 1.5 TESLA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 73