MAUDE Adverse Event Report: GENERAL ELECTRIC CO. GENERAL ELECTRIC 1.5T MRI SCANNER ; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number SIGNA 1.5T

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 04/01/2019

Event Type  Injury  

Event Description

Four days following an mri lumbar scan, pt called to state she had been burned by scanner.Fda safety report id # (b)(4).

• Brand Name: GENERAL ELECTRIC 1.5T MRI SCANNER
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GENERAL ELECTRIC CO. ; waukesha WI 53188
• MDR Report Key: 8564947
• MDR Text Key: 143601198
• Report Number: MW5086253
• 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: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SIGNA 1.5T
• 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 Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 151