MAUDE Adverse Event Report: SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. MAGNETOM ESSENZA DOT; MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Model Number	10837633
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is on-going.A supplemental report will be submitted if additional information becomes available.
Event or Problem Description
It was reported to siemens that an adverse event occurred following examination on the magnetom essenza dot system.One patient showed some redness on the right arm during an examination.The examination was stopped and the patient was repositioned.Another patient complained of heat in his wrist during a wrist exam.The procedure was re-started and successfully completed.The user also observed that most patients are sweating during the mri scans.The reported events occurred in (b)(6).
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.Two patients complained of an overheating sensation during examination.The first patient reported redness on the right arm and did not require any medical treatment, however, no further details could be provided by the customer.The second patient reported overheating on the wrist during a wrist exam.In this event, the procedure was interrupted, the patient was repositioned and the exam was restarted and ran normally.During the investigation the r&d experts reviewed the reports and images which were provided by the service engineer.Neither patient had tattoos on the skin.It was confirmed that the squeeze ball was in good condition before and during the examination and the patients were informed of the use of the squeeze ball.Neither patient pressed the squeeze ball during examination and the scanning continued after evaluation by the doctor.There was a sar message pop-up for one patient with warming sensation during the scanning.Review of the qa and tune-up reports, especially for the qa report of foot/ankle coil, found no abnormality.The coil power loss was not provided, however, no suspicious findings were noted in the qa reports.The dicom image of the examination was deleted and no longer unavailable for analysis.Therefore, the specific energy dose could not be evaluated.No savelog was caputured when the incident occurred, therefore, it cannot be checked whether any abnormal situation ocurred during the scanning.The air filter of the patient fan was set to minimum during the scanning.The service engineer set it to the maximum during evaulation.It is suspected that the warming of the patient's forearm was caused by contact with the body coil based on the feedback from the service engineer.It is recommended to review patient positioning and provide cushions to avoid any touch to the body coil or any current loop during the scanning.The room temperature is set as 24.2 celsius degree while the technical documentation (id: m4-060.891.01.08.02) requires the examination room temperature is +18 to +22celsius degree.It is strongly recommended that the customer set the room temperature as the t-doc states.It is suggested that the customer set the filter fan to the maximum setting to keep the patient cool during the scanning.No further actions are planned by the manufacturer as no system malfunction was identified.

• Brand Name: MAGNETOM ESSENZA DOT
• Common Device Name: MAGNETIC RESONANCE DIAGNOSTIC DEVICE
• Manufacturer (Section D): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; gaoxin c ave.; 2nd, hi-tech industrial park; shenzhen, 51805 7; CH 518057
• MDR Report Key: 11029478
• Report Number: 3004754211-2020-59477
• Device Sequence Number: 16310765
• Product Code: LNH
• UDI-Device Identifier: 04056869006772
• UDI-Public: 04056869006772
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2020

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: 10837633
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other