MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC.; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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

Patient Problem Burn, Thermal (2530)

Event Date 04/29/2019

Event Type  malfunction  

Event Description

Patient presented with three distinct burns on right distal calf, ankle and 5th digit following mri.Parents were getting a patient dressed when they noticed an area under the patient's cotton sock and pulled the sock off.The area on the 5th digit and ankle were focal blisters; the lesion on the right lateral calf was approximately 6-8 cm long with 2 cm extending outside of the patient's sock.The patient had a cotton sock on the other foot and there was no lesion on that side.The machine was evaluated to see if there was any source of focal heating.No item was identified.The sheet, sock, and patient id which was on the right ankle was retained.None of them appear to have been a conductive risk.Our medical physicist and credentialed mr safety expert was contacted to evaluate the delivery of radiofrequency radiation.Evaluation of the sar values for each sequence is being done currently.The radiology team has notified siemens of incident.At this point, there is no known cause for these burns.

• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 40 liberty boulevard; mailcode: 64-1a; malvern PA 19355
• MDR Report Key: 8678200
• MDR Text Key: 147316164
• Report Number: 8678200
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/04/2019,05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1095 DA