MAUDE Adverse Event Report: SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. MAGNETOM ESSENZA DOT; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	10836666
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens checked the system maintenance history and found that the pms done on time and no tales replacement is due.The room temperature was normal, and the patient cooling fan was running well.There have not been rf-related errors recently reported by customer.A post-incident system safety check was performed, and no deviation was found in system.Strict instruction was given to customer to follow safety precautions before performing any patient study.Siemens will submit a supplemental report if any additional reportable information available.Internal id# (b)(4).
Event or Problem Description
It was reported that a patient was burned during an mri shoulder study using the magnetom essenza dot system and a flex 4 large coil.The burn symptoms were observed on an area of skin one day after the scan.Based on the information obtained by siemens so far, the patient has skin disease and wore a metal accessory during the scan near the scan area.The burn was observed in the area where the metal accessory was worn.The degree and extent of the burn area and the necessity of medical intervention are unknown.System maintenance information provided by the engineer reported the system was not faulty and no allegation of complaint against the system is alleged.This report is being submitted to address the burn injury sustained by the patient.The patient burn is considered a serious injury.The reported event occurred in india.
Additional Manufacturer Narrative
Siemens completed the analysis of the reported event and obtained additional event and patient information.It was clarified that the patient felt skin tenderness at the area near the scan (neck and arm) and skin redness was observed in these areas one day after the examination.No medical treatment was necessary.The following analysis results were based on information obtained from the local customer service engineer (cse), qa and bc tuning reports, examination of the complaint system and logs, and expert review: 1.The patient wore a gold chain (metal material 30cm in length) around her neck and her arm above the upper abdominal area during the scan.The patient did not have tattoos in the complaint area and wore cotton clothing.2.According to the system operator manual (m4-06001.621.03.01.02), "metal chain is one of the contraindications for an mr examination.3.The dicom image of the examination was analyzed, and a metal artifact was detected in the shoulder image.4.Qa and bc tuning reports were checked by experts.All test items were found to be correct.5.No rf-related errors were reported by the customer recently (exact timeframe unknown), and according to the system save log provided by the local cse, no errors were reported.6.The sar monitoring works well based on the relevant test results which all passed.The specific energy dose in this case was 740.23 j/kg and was below the limit of 14,4000 j/kg as listed in iec 60601-2-23 "particular requirements for safety of magnetic resonance equipment for medical diagnosis".7.It was confirmed that the squeeze ball, patient fan, and coil power loss, were in good condition before and during the patient's examination.The patient didn't feel uncomfortable during the examination and did not press the squeeze ball to alert the operator.In conclusion, no system malfunction was detected, and the system worked as specified.The patient experienced skin redness and tenderness because she wore a gold chain during the examination.Magnetic fields can induce an eddy current within the gold object.The eddy current will form high impedance at the interface between metal and skin, then generate heat, which can result in burns.As a "metal chain" is one of the contraindications for an mr exam according to the system operator manual, the root cause of the issue is user error.This complaint has been closed.

• Brand Name: MAGNETOM ESSENZA DOT
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; gaoxin c ave.; 2nd, hi-tech industrial park; shenzhen, 51805 7; CH 518057
• Manufacturer (Section G): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; gaoxin c ave.; 2nd, hi-tech industrial park; shenzhen, 51805 7; CH 518057
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 15751155
• Report Number: 3004754211-2022-51844
• Device Sequence Number: 12312862
• Product Code: LNH
• UDI-Device Identifier: 04056869006789
• UDI-Public: 04056869006789
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K161795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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
• Operator of Device: Health Professional
• Device Model Number: 10836666
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Female