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

Model Number MAGNETOM ALTEA

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 10/06/2023

Event Type  Injury  

Event Description

Patient had minor thermal burns to inner thighs from mri of the knee.Patient experienced redness to top of thighs and small blisters on the inside of thighs.

• Brand Name: SIEMENS MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS AG/SIEMENS HEALTHCARE GMBH
• MDR Report Key: 17949569
• MDR Text Key: 326006374
• Report Number: MW5147005
• 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: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAGNETOM ALTEA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White