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

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

Patient Problems Sweating (2444); Burn, Thermal (2530); Alteration In Body Temperature (2682)

Event Date 11/20/2018

Event Type  Injury  

Event Description

Pt's wife called our centralized scheduling office on (b)(6) 2018 to report a burn noted after mri lumbar spine with and without on (b)(6) 2018.The scheduled called the site and was told to instruct the pt to f/u with his family practitioner.The mri technologist called to f/u with pt later that day.The pt stated that he had not noticed any burns after the mri, but did state that he was hot and sweaty.When he arrived home after the mri exam, he noticed a small burn on thumb (knuckle) and hip.He thought nothing of it, but his wife insisted he call the office.He declined requests to f/u with a physician.The pt was imaged on a siemens espree 1.5t mri unit.Serial # (b)(4).Our siemens engineer evaluated the equipment and his report found "tests, checks, inspections and / or repairs have been performed in accordance with the specific service task.The system is functioning properly based upon completion of the specific service task undertaken by siemens." post operative mri lumbar spine due to pain / radiculopathy.

• Brand Name: ESPREE MRI UNIT
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS AG / SIEMENS HEALTHCARE GMBH; 40 liberty blvd; mailcode 65-10; malvern PA 19355
• MDR Report Key: 8151008
• MDR Text Key: 130307557
• Report Number: MW5082000
• 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: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 77