• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC.; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SIEMENS MEDICAL SOLUTIONS USA, INC.; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn, Thermal (2530)
Event Date 04/29/2019
Event Type  malfunction  
Event Description
Patient presented with three distinct burns on right distal calf, ankle and 5th digit following mri.Parents were getting a patient dressed when they noticed an area under the patient's cotton sock and pulled the sock off.The area on the 5th digit and ankle were focal blisters; the lesion on the right lateral calf was approximately 6-8 cm long with 2 cm extending outside of the patient's sock.The patient had a cotton sock on the other foot and there was no lesion on that side.The machine was evaluated to see if there was any source of focal heating.No item was identified.The sheet, sock, and patient id which was on the right ankle was retained.None of them appear to have been a conductive risk.Our medical physicist and credentialed mr safety expert was contacted to evaluate the delivery of radiofrequency radiation.Evaluation of the sar values for each sequence is being done currently.The radiology team has notified siemens of incident.At this point, there is no known cause for these burns.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS USA, INC.
40 liberty boulevard
mailcode: 64-1a
malvern PA 19355
MDR Report Key8678200
MDR Text Key147316164
Report Number8678200
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/04/2019,05/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/04/2019
Event Location Hospital
Date Report to Manufacturer06/07/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/07/2019
Type of Device Usage N
Patient Sequence Number1
Patient Age1095 DA
-
-