MAUDE Adverse Event Report: SIEMENS AG / SIEMENS HEALTHCARE GMBH SIEMENS MRI AVANTO 1.5T; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Use of Device Problem (1670)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 02/27/2023

Event Type  Injury  

Event Description

Proximity rf(radio frequency) burn to right elbow during mri(magnetic resonance imaging) of left shoulder.

• Brand Name: SIEMENS MRI AVANTO 1.5T
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS AG / SIEMENS HEALTHCARE GMBH
• MDR Report Key: 16487470
• MDR Text Key: 310822375
• Report Number: MW5115436
• 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: 02/28/2023

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White