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U.S. Department of Health and Human Services

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

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SIEMENS AG/SIEMENS HEALTHCARE GMBH SIEMENS AERA 1.5T SCANNER SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
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).
 
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Brand NameSIEMENS AERA 1.5T SCANNER
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
SIEMENS AG/SIEMENS HEALTHCARE GMBH
MDR Report Key13425260
MDR Text Key285062263
Report NumberMW5107141
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received02/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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