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

Device Problem Use of Device Problem (1670)

Patient Problems Burning Sensation (2146); Partial thickness (Second Degree) Burn (2694)

Event Date 12/29/2021

Event Type  Injury  

Event Description

On (b)(6) 2021 an elderly, male inpatient underwent an mri left hip on a siemens aera 1.5t scanner and sustained what ended up being a 2nd degree rf thermal burn to the right hip region.The patient was dressed only in a hospital gown prior to being brought down for the exam.No residual stickers or metallic components remained from the floor, the patient's skin was properly protected from the inside of the scanner bore, and he was scanned in normal mode with vitals monitored by a rad rn due to his mr conditional pacemaker.The patient was not given the squeeze ball before starting the exam.Approx 1/3 into exam, rn went into mri room to check on pt and reposition monitoring equipment to get a better reading.Pt was laying flat at the time.They decided to prop his head and chest up with pillows to help him breathe better.The mri was continued and the technologist updated the patient multiple times on scan time remaining.The tech confirmed that the speaker was turned on for a brief moment during his updates in order to hear any response from the patient, which there was none.After the mri, the patient mentioned feeling a burning sensation to the right hip area that occurred during the exam.When asked why he didn't say during the mri, the patient replied that he did not want to move and ruin the study.Mri tech examined the area and only noticed slight redness.The tech then appropriately filled out an internal report as possible thermal injury and notified his upline and the mrso.Upon return to his room, the patient noted the burning sensation to his rn.From then on, daily documented follow-up and dressing changes were conducted throughout the remainder of the patient's admission.Wound consult: initial consult on (b)(6) and exiting consult on (b)(6) 2022 suggested skin ulcer over burn.Site is healing.Conversations with wound team experts to be had to ensure proper education for how mri burns occur.The elderly patient had loose abdominal tissue that folded over his waist area.When the patient was propped up, this increased the fold and resulted in skin to skin contact.It's believed that the diffuse rf heating from the mri hip study caused sweat to accumulate in the skin fold which created a focal e-field pathway, resulting in a burn.Fda safety report id# (b)(4).

• Brand Name: SIEMENS AERA 1.5T SCANNER
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS AG/SIEMENS HEALTHCARE GMBH
• MDR Report Key: 13425260
• MDR Text Key: 285062263
• Report Number: MW5107141
• 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: 01/29/2022

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: 02/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 114 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White