MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH - MR MAGNETOM AVANTO; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	07391167
Medical Device Problem Code	Electromagnetic Compatibility Problem (2927)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.
Event or Problem Description
It was reported to siemens that an adverse event occurred following examination on the magnetom avanto system.It was reported that a patient suffered a burn and area of necrosis when using ecg electrodes.The injuries occurred in the area of the ecg electrodes used (covidien kendall 630 foam electrodes conductive adhesive hydrogel, radiolucent, lot number: 000652x).The patient was evaluated by a dermatologist for curative care and released.We are unaware of any further impact to the state of health of the patient involved.Siemens has requested additional information in order to conduct an investigation of the reported event.
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.It was reported that there has been a patient skin redness and burns with necrosis when using ecg electrodes.After the examination, the nurse noticed burns at three locations where the ecg leads were attached.The customer did not give many details about the treatment, only that after the examination the patient went to a dermatologist and had curative treatment and was sent home.Our experts analyzed the images generated during the patient's examination.The complete examination of the patient's head/neck lasted 144.85 min with an active scanning time of 120.81 min.No abnormality was found which would indicate a system malfunction.The complete measurement was performed in the normal operating mode.The sar values were within the limits defined by the mr safety standard (iec 60601-2-33), i.E., the maximum applied sar was (b)(4) of the normal mode limit.The applied rf in this case should not represent a risk under normal circumstances and scan conditions.Furthermore, the patient absorbed 99.16 wmin/kg which is below the limit of 240 wmin/kg defined in the mr safety standard (iec 60601-2-33).The mr system has been checked.Although some tests have failed in correlation with the rf power amplifier, it is very unlikely that these hardware deviations could be a cause of the injuries.The root cause for the injuries could be the use of non-mr compatible ecg leads or the applied hydrogel, which is electrically conductive.The following ecg leads were used: covidien kendall 630 foam electrodes - conductive adhesive hydrogel, radiolucent.It seems that the electrodes used are mainly designed for use in ct scans and not for mri scans.Each external device must be checked for mr safety and mr compatibility before using it in mri.Corresponding information can be found in the magenetom family - operator manual - mr-system - syngo mr b19 (pages 27 to 28).Print no.Mr-01501g.621.01.02.02.Additionally, our experts noticed that apparently no distance cushions have been used to assure a minimal distance between the patient's arms and torso.This could lead to a rf current loop which may be generated when parts of the body touch.This effect and the preventive measures are described in the operator manual mentioned above on pages 19 to 21.In summary no hardware or software problem was found by our system that would explain the patient's burn.

• Brand Name: MAGNETOM AVANTO
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 13692972
• Report Number: 3002808157-2022-17748
• Device Sequence Number: 1944237
• Product Code: LNH
• UDI-Device Identifier: 04056869006611
• UDI-Public: 04056869006611
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K123938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2022

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: 07391167
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 05/09/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown