MAUDE Adverse Event Report: GENERAL ELECTRIC COMPANY DISCOVERY MR 750 3.0T; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	DISCOVERY MR750 3.0T
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Mr's control panel had an electrical shortage thought to be from the use of saturated cleaning wipes which caused corrosion.This morning when entering the scan room to run the morning acr, techs noticed the room had an odd odor.It was then noticed that the control panel had melting plastic and extreme heat coming from it.Service was notified and the emergency power off was pressed.Service came, evaluated, and fixed the scanner.

• Brand Name: DISCOVERY MR 750 3.0T
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GENERAL ELECTRIC COMPANY; 3000 n. grandview blvd; waukesha WI 53188
• MDR Report Key: 13341780
• Report Number: 13341780
• Device Sequence Number: 17133137
• Product Code: LNH
• UDI-Device Identifier: 00840682115872
• UDI-Public: 00840682115872
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2022
• Report Date (Section F): 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DISCOVERY MR750 3.0T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 13 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/13/2022